Safety
Enforcement Report for January 19, 2011
January 19, 2011 11-03
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Food Club Creamy Frosting Vanilla, packaged in 16-oz. plastic tubs, 12/case, UPC 0-36800-70235-6. Recall F-0326-2011
CODE
Tub code - JUL 27 11 XMC; case code AUG 23 11XW
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilster-Mary Lee Corp., Chester, IL, by e-mail on November 1, 2010.
Manufacturer: Gilster-Mary Lee Corp., Mc Bride, MO. Firm initiated recall is ongoing.
REASON
Some containers of chocolate frosting containing milk were mislabeled as vanilla frosting
VOLUME OF PRODUCT IN COMMERCE
130/12-tub cases
DISTRIBUTION
OH, VA, AL, and TX
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PRODUCT
1) Liz Lovely Cowboy Cookies pack size, 2 cookies UPC 8-93410-00001-8. Recall # F-0327-2011;
2) Liz Lovely Cowgirl Cookies pack size, 2 cookies UPC 8-93410-00005-6. Recall # F-0328-2011;
3) Liz Lovely Peanut Butter Classics cookies pack size, 2 cookies UPC 8-93410-00002-5. Recall # F-0329-2011;
4) Liz Lovely Gluten Free Chocolate Fudge pack size, 2 cookies UPC 8-93410-00100-8. Recall # F-0330-2011;
5) Liz Lovely Gluten Free Triple Chocolate Mint cookies pack size, 2 cookies UPC 8-93410-00112-1. Recall # F-0331-2011;
6) Liz Lovely Lovely Oh's cookies 8 oz container UPC 8-93410-00211-1. Recall # F-0332-2011;
7) Liz Lovely Mint Lovely Oh's cookies 8 oz container UPC 8-93410-00215-9. Recall # F-0333-2011;
8) Liz Lovely Peanut Butter Lovely Oh's cookies 8 oz container UPC 8-93410-00228-9. Recall # F-0334-2011;
9) Liz Lovely Organic Pretzels 8 oz container UPC 8-93410-00208-1. Recall # F-0335-2011
CODE
1) Lots 00497, 00504, 00515;
2) Lots 00493, 00503, 00512;
3) Lots 00496, 507;
4) Lots 00499, 00415, 00514;
5) Lots 00506
6) – 9) Lots 00501, 00513
RECALLING FIRM/MANUFACTURER
Liz Lovely, Inc., Waitsfield, VT, by telephone and letter on November 15, 2010. Firm initiated recall is ongoing
REASON
Undeclared milk allergen in cookie products labeled "Dairy Free”.
VOLUME OF PRODUCT IN COMMERCE
1403 cases, 12 packs/case; 103 cases, 6 containers/case
DISTRIBUTION
Nationwide except Alaska and Hawaii
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PRODUCT
Organic Tahini Butter in 16 oz. jars. Recall # F-0336-2011
CODE
Lot 90811
RECALLING FIRM/MANUFACTURER
Premier Organics, Oakland, CA, by letters and press release on September 4, 2010. FDA initiated recall is complete.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
840 (16 oz.) cases
DISTRIBUTION
Nationwide
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PRODUCT
Golden Dipt Fry Easy All-Purpose Batter, 10 ounce carton, UPC Code 4123470111. Packed as 12 cartons/case. Recall # F-0337-2011
CODE
"BEST BY" date of NOV 17 11 AH
RECALLING FIRM/MANUFACTURER
McCormick & Company, Inc., Hunt Valley, MD, by press release, letter and e-mail on November 29, 2010. Firm initiated recall is ongoing.
REASON
Ingredients containing egg were packaged into retail product which did not declare the egg on the label.
VOLUME OF PRODUCT IN COMMERCE
23 cases
DISTRIBUTION
Southeastern US
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
'Leal's Best' Flour Tortillas. 12 tortilla/bag (7" and 8" flour tortillas). Packaged in a large, clear plastic bag placed in a cardboard packaging box. 20 Dozen/Case. Recall # F-0338-2011
CODE
Date code: 11/01/10
RECALLING FIRM/MANUFACTURER
Leals Tortilla Factory & Restaurant, Muleshoe, TX, by email on November 3, 2010. Firm initiated recall is ongoing.
REASON
The product has been recalled to clarify "Allergen declarations" on the product (or case) label. Product list whey but not milk and contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
Approx. 6000 lbs
DISTRIBUTION
NM, TX
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PRODUCT
Plain Pound Cake is packaged in 14 oz. in a Nova tray, wrapped in sealed clear plastic packing. The product has the UPC 7 17887 16720 6. Product labeling reads in part: "***QFC Plain POUND CAKE Baked fresh by SCHWARTZ BROTHERS BAKERY***INGREDIENTS: Creme Cake Mix***Wheat Flour***Soybean Oil, Modied Food Starch, Dried Whey, Palm Oil, Leavening***Wheat Gluten, Salt***Whole Eggs, Canola Oil*** Water*** Contains: Egg, Soy, Wheat***May Contain Milk, Peanuts, Tree Nuts...Net Wt 14 oz. (396g). Recall # F-0339-2011
CODE
SELL BY 42209
RECALLING FIRM/MANUFACTURER
John Schwartz, Gretchens Mathers, Bill Schwartz DBA Schwartz, Seattle, WA. by telephone and letter beginning April 17, 2009. Firm initiated recall is complete.
REASON
Pound cakes declared whey on ingredient statement, but did not declare milk on label.
VOLUME OF PRODUCT IN COMMERCE
153 loaves
DISTRIBUTION
WA
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PRODUCT
Eagle Flats Queso Cheese Dip Mild, UPC 0 93072 00005 4, and Eagle Flats Queso Cheese Dip Hot, UPC 0 93072 00004 7, 16 oz (454g) l lb. Recall # F-0340-2011
CODE
All lots distributed within the last 2 years (December 2008 to December 2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: austin-paige, inc - dba 'eagle flats', Vernon, TX, by telephone on December 17, 2010.
Manufacturer: Hell On The Red, Inc., Telephone, TX. Firm initiated recall is ongoing.
REASON
Undeclared source of cheese on product labeling.
VOLUME OF PRODUCT IN COMMERCE
5,132 cases with 12 jars each
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
1) Metoprolol Tartrate Tablets, USP, 50 mg, a) 100 count bottles (NDC 0781-1223-01), b) 1000 count bottles (NDC 0781-1223-10), Rx only. Recall # D-162-2011;
2) Metoprolol Tartrate Tablets, USP, 100 mg, a) 100 count bottle (NDC 0781-1228-01), b) 1000 count bottles (NDC 0781-1228-10), Rx only. Recall # D-163-2011
CODE
1) Lot #: a) NDC 0781-1223-01: 170048, Exp 11/10; 170900, Exp 01/11; 173554, Exp 02/11; 176221, Exp 06/11; 176225, Exp 04/11; 184025, Exp 04/12; 188709, Exp 08/12; 191185, Exp 10/12; 192071, Exp 01/13; 192692, Exp 02/13; 196857, Exp 06/13; V09014, Exp 02/12; V09018, Exp 06/12 b) NDC 0781-1223-10: 169335, Exp 10/10; 169336, Exp 10/10; 170045, Exp 09/10; 170608, Exp 12/10; 170609, Exp 12/10; 170896, Exp 01/11; 170897, Exp 01/11; 170898, Exp 01/11; 170899, Exp 01/11; 170901, Exp 01/11; 170902, Exp 02/11; 170903, Exp 02/11; 170904, Exp 02/11; 171021, Exp 10/10; 171023, Exp 12/10; 172801, Exp 12/10; 172802, Exp 12/10; 172803, Exp 12/10; 173553, Exp 02/11; 173554, Exp 02/11; 173555, Exp 03/11; 173556, Exp 03/11; 173557, Exp 04/11; 173558, Exp 04/11; 173559, Exp 05/11; 173560, Exp 06/11; 173570, Exp 05/11; 173721, Exp 02/11; 173722, Exp 05/11; 175127, Exp 03/11; 176218, Exp 05/11; 176219, Exp 04/11; 176220, Exp 06/11; 176221, Exp 06/11; 176222, Exp 06/11; 176223, Exp 07/11; 176224, Exp 07/11; 176225, Exp 04/11; 176367, Exp 07/11; 176368, Exp 04/11; 176369, Exp 04/11; 177270, Exp 07/11; 177273, Exp 08/11; 177371, Exp 08/11; 179061, Exp 08/11; 179062, Exp 09/11; 179063, Exp 09/11; 179064, Exp 09/11; 179065, Exp 09/11; 179066, Exp 09/11; 179067, Exp 09/11; 179068, Exp 09/11; 179069, Exp 08/11; 179071, Exp 07/11; 179768, Exp 08/11; 179769, Exp 08/11; 180034, Exp 10/11; 180035, Exp 10/11; 180036, Exp 10/11; 180520, Exp 11/11; 180521, Exp 11/11; 180538, Exp 09/11; 181703, Exp 12/11; 181704, Exp 12/11; 181705, Exp 12/11; 181706, Exp 01/12; 182792, Exp 01/12; 183338, Exp 01/12; 184025, Exp 04/12; 186109, Exp 04/12; 186141, Exp 04/12; 187299, Exp 06/12; 187300, Exp 06/12; 188707, Exp 07/12; 188708, Exp 07/12; 188709, Exp 08/12; 188988, Exp 08/12; 188989, Exp 09/12; 188991, Exp 06/12; 190235, Exp 08/12; 190236, Exp 09/12; 190237, Exp 11/12; 191185, Exp 10/12; 192068, Exp 11/12; 192069, Exp 12/12; 192070, Exp 12/12; 192071, Exp 01/13; 192072, Exp 01/13; 192073, Exp 02/13; 192074, Exp 01/13; 192075, Exp 01/13; 192692, Exp 02/13; 192693, Exp 03/13; 193923, Exp 03/13; 194782, Exp 02/13; 195270, Exp 04/13; 195271, Exp 04/13; 196317, Exp 06/13; 196856, Exp 06/13; 196858, Exp 06/13; 197460, Exp 06/13; V07059, Exp 10/10; V09012, Exp 02/12; V09013, Exp 02/12; V09014, Exp 02/12; V09017, Exp 06/12; V09018, Exp 06/12; V09019, Exp 05/12;
2) Lot #: a) NDC 0781-1228-01: 169343, Exp 10/10; 169344, Exp 10/10; 169475, Exp 11/10; 170615, Exp 12/10; 170616, Exp 12/10; 170618, Exp 01/11; 170620, Exp 01/11; 170908, Exp 02/11; 171439, Exp 03/11; 171440, Exp 03/11; 171443, Exp 03/11; 172147, Exp 04/11; 172149, Exp 04/11; 172150, Exp 04/11; 172151, Exp04/11; 172152, Exp 04/11; 172861, Exp 12/10; 172862, Exp 01/11; 172863, Exp 01/11; 175128, Exp 05/11; 175129, Exp 04/11; 176227, Exp 06/11; 176228, Exp 06/11; 176230, Exp 04/11; 176236, Exp 05/11; 176373, Exp 05/11; 177274, Exp 07/11; 177276, Exp 07/11; 177644, Exp 06/11; 177645, Exp 05/11; 178448, Exp 06/11; 178449, Exp 06/11; 179075, Exp 08/11; 179076, Exp 08/11; 179077, Exp 09/11; 179078, Exp 09/11; 179080, Exp 09/11; 179082, Exp 10/11; 179638, Exp 10/11; 179639, Exp 10/11; 179640, Exp 10/11; 180038, Exp 10/11; 180039, Exp 10/11; 180061, Exp 11/11; 180762, Exp 09/11; 180763, Exp 09/11; 181708, Exp 12/11; 181710, Exp 01/12; 181711, Exp 01/12; 181712, Exp 12/11; 181713, Exp 12/11; 182785, Exp 01/12; 182786, Exp 01/12; 182788, Exp 01/12; 182790, Exp 01/12; 184754, Exp 02/12; 187305, Exp 06/12; 187307, Exp 07/12; 187781, Exp 07/12; 188711, Exp 08/12; 190238, Exp 09/12; 191513, Exp 01/13; 192076, Exp 11/12; 192079, Exp 12/12; 192694, Exp 02/13; 192695, Exp 02/13; 193928, Exp 03/13; 194785, Exp 03/12; 195276, Exp 05/13; 195277, Exp 05/13; 196321, Exp 06/13; V07075, Exp 12/10; V07076, Exp 12/10; b) NDC 0781-1228-10: 169474, Exp 11/10; 170613, Exp 12/10; 170614, Exp 12/10; 170617, Exp 12/10; 170619, Exp 01/11; 170907, Exp 02/11; 170909, Exp 02/11; 171438, Exp 02/11; 171442, Exp 03/11; 172145, Exp 10/10; 172148, Exp 04/11; 172152, Exp 04/11; 173723, Exp 02/11; 175130, Exp 05/11; 176004, Exp 05/11; 176229, Exp 04/11; 176234, Exp 06/11; 176236, Exp 05/11; 177275, Exp 07/11; 177277, Exp 07/11; 177279, Exp 06/11; 177281, Exp 05/11; 177643, Exp 05/11; 179073, Exp 08/11; 179074, Exp 08/11; 179079, Exp 09/11; 179637, Exp 10/11; 180040, Exp 11/11; 180062, Exp 11/11; 180524, Exp 11/11; 180526, Exp 12/11; 180812, Exp 09/11; 181707, Exp 12/11; 181709, Exp 01/12; 182784, Exp 01/12; 182787, Exp 01/12; 182789, Exp 01/12; 183025, Exp 01/12; 183341, Exp 02/12; 183342, Exp 02/12; 183343, Exp 03/12; 183344, Exp 03/12; 183345, Exp 03/12; 184071, Exp 03/12; 184072, Exp 03/12; 184751, Exp 03/12; 184755, Exp 02/12; 185508, Exp 05/12; 185510, Exp 04/12; 186110, Exp 05/12; 187301, Exp 05/12; 187302, Exp 05/12; 187303, Exp 05/12; 187304, Exp 06/12; 187306, Exp 06/12; 187637, Exp 07/12; 187638, Exp 07/12; 187782, Exp 07/12; 188710, Exp 07/12; 188712, Exp 08/12; 188713, Exp 08/12; 188992, Exp 08/12; 188993, Exp 09/12; 188994, Exp 09/12; 188995, Exp 09/12; 189276, Exp 07/12; 189487, Exp 07/12; 190239, Exp 09/12; 190240, Exp 09/12; 191188, Exp 10/12; 191189, Exp 10/12; 191514, Exp 11/12; 191515, Exp 11/12; 192077, Exp 12/12; 192078, Exp 12/12; 192080, Exp 01/13; 192081, Exp 01/13; 192084, Exp 01/13; 192085, Exp 01/13; 192088, Exp 01/13; 192089, Exp 02/13; 193924, Exp 02/13; 193925, Exp 02/13; 193926, Exp 03/13; 193927, Exp 03/13; 194786, Exp 03/13; 194787, Exp 03/13; 195273, Exp 04/13; 195274, Exp 04/13; 195275, Exp 05/13; 196319, Exp 06/13; 196320, Exp 06/13; 196322, Exp 07/13; V07077, Exp 12/10
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letter on November 18, 2010. Firm initiated recall is ongoing
REASON
Failed USP Content Uniformity Requirements: Metoprolol batches may exhibit non-homogenous granulation.
VOLUME OF PRODUCT IN COMMERCE
100 count: 2,043,192 bottles; 1000 count 724,482 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Valacyclovir Hydrochloride Tablets, 1 gram, 30 count bottle. Recall # D-164-2011
CODE
Lot No. 059791A, Expiration Date 04/22/2010 to 04/26/2010
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Roxane Inc., Columbus, OH, by letter, on October 28, 2010. Firm initiated recall is ongoing.
REASON
This recall is being conducted due to a stability failure on dissolution testing. All other product parameters were within specifications and there have been no adverse events reported for the affected lot.
VOLUME OF PRODUCT IN COMMERCE
12,950 units
DISTRIBUTION
AL, CA, FL, IL, NY, PA, TX
___________________________________
PRODUCT
1) Oxytocin Injection, USP (Synthetic), 10 units/1 mL, 1 mL Single Dose Vial (NDC 0703-6271-01), packaged in 25 Vials per carton (NDC 0703-6271-04), Rx only. Recall # D-165-2011;
2) Oxytocin Injection, USP (Synthetic), 100 units/10 mL (10 units/mL), 10 mL Multiple Dose Vial (NDC 0703-6275-01), packaged in 10 Vials per carton (NDC 0703-6275-03), Rx only. Recall # D-166-2011
CODE
1) Lot #: 31308757B, Exp 12/10; 31309622B, Exp 01/11, and 31310805B, Exp 04/11
2) Lot #: 31309831B, Exp 02/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, letters on November 10, 2010.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: The product doesn't meet impurity specifications through expiry.
VOLUME OF PRODUCT IN COMMERCE
462,490 vials
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
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PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0057-11
CODE
Unit: K181142
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on December 15, 2005.
Manufacturer: Puget Sound Blood Center and Program, Renton West Renton, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0198-11
CODE
Unit: W020004104897
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Navy, Bethesda, MD, by facsimile on January 17, 2006.
Manufacturer: National Naval Medical Center Building, Bethesda, MD. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0199-11
CODE
Unit: W227010026988
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone on November 16, 2010 and by facsimile on November 17, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0200-11
CODE
Unit: W227010026985
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone on November 16, 2010 and by letter on November 17, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0252-11
CODE
Unit: W038510313999
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on October 28, 2010. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC, GA
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-0254-11;
2) Red Blood Cells. Recall # B-0255-11
CODE
1) Unit: 011KM39410;
2) Units: 011KM38645, 011KM39410
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on July 18, 2010 and letter on August 3, 2010 and by letter on September 7, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MO, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0353-11
CODE
Unit: W091010277180
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute Tulsa Center, Tulsa, OK, by telephone on October 1, 2010 and by facsimile on November 11, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0354-11
CODE
Unit: W037909187447
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on March 08, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0453-11
CODE
Unit: 72E61018X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc, Birmingham Region, Birmingham, AL, by fax on June 27, 2008. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0462-11
CODE
Unit: G211812
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by fax on October 24, 2005.
Manufacdturer: Puget Sound Blood Center and Program, Olympia, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0538-11
CODE
Units: TA2098990, TA2099167, TA2099772, TA2100033, TA2100587, TA2100876, TA2101440, TA2101741, TA2102676, TA2103035, TA2103473, TA2103761, TA2104408, TA2104625, TA2105121, TA2105526
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax on July 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0571-11
CODE
Unit # 49GP35324
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on August 31, 2007. Firm initiated recall is complete.
REASON
Blood product, collected using an apheresis kit which has been opened greater than 8 hours, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0572-11
CODE
Unit: 0155151
RECALLING FIRM/MANUFACTURER
United States Blood Bank, Inc., Miami, FL, by facsimile on October 31, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested repeat reactive for the hepatitis C virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0580-11
CODE
Unit: 49GN62122
RECALLING FIRM/MANUFACTURER
American National Red Cross, SW Region – HT, Tulsa, OK, by telephone on May 8, 2008. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-0581-11
CODE
Unit: EQ038621
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc of Wisconsin, Madison, WI, by fax and telephone on October 14, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a current physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0582-11;
2) Platelets. Recall # B-0583-11;
3) Fresh Frozen Plasma. Recall # B-0584-11;
4) Recovered Plasma. Recall # B-0585-11
CODE
1) Units: 4843759; 4416022;
2) and 3) Unit: 4843759;
4) Unit: 4416022
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on January 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MS, TX, MI, OK, and Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0588-11;
2) Plasma Frozen. Recall # B-0589-11
CODE
1) and 2) Unit: 49FF62184
RECALLING FIRM/MANUFACTURER
National Red Cross SW Region – HT, Tulsa, OK, by fax on December 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0590-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0591-11;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-0593-11
CODE
1) Unit: 49GV43537;
2), 3) Unit: 49GP37886
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on August 3, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, OK, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B--0594-11;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0595-11
CODE
1) Unit: 7594410;
2) Unit: 7597288
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on October 23, 2008. Firm initiated recall is complete
REASON
Blood products, possibly contaminated with air, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, OK
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0596-11;
2) Platelets. Recall # B-0597-11
CODE
1) Units: 4924790; 7204108; 5355989;
2) Unit: 4924790
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on November 3, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK, TX, MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0604-11
CODE
Unit: 7653230
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc-cellular Therapy Laboratory, New York, NY, by telephone on October 23, 2007 and by letter dated October 24, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Staphylococcus warneri and Diptheroids, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0605-11
CODE
Unit: 7023942
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc, New York, NY, by fax and telephone on May 15, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with diptheroids, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0606-11
CODE
Unit: 7002693
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on April 4, 2007 and by letter dated April 24, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium species, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0607-11
CODE
Units: 4040243985, 4040243361, 4040242180, 4040240843, 4040240200, 4040220261, 4040203974, 4040199859, 4040199185, 4040198148, 4040184888, 4040180071, 4040178671, 4040174918, 4040174506, 4040161899, 4040160283, 4040159188, 4040153228, 4040152808, 4040151992, 4040151440, 4040150546, 4040149067, 4040148157, 4040142292, 4040141290, 4040139830, 4040139159, 4040138530, 4040136764, 4040135722, 4040133951, 4040132815, 4040131618, 4040130160, 4040129094, 4040128625, 4040127920, 4040127498, 4040126090, 4040125281, 4040124784, 4040124037, 4040122349, 4040121433, 4040120985, 4040120072, 4040119140, 4040118663, 4040117926, 4040117421, 4040116668, 4040116015, 4040115226, 4040114803, 4040114132, 4040112796, 4040112038, 4040111599, 4040110928, 4040110482, 4040109824, 4040108886, 4040108241, 4040107313, 4040107021, 4040106055, 4040105717, 4040104864, 4040104180, 4040103794, 4040103315, 4040102644, 4040102030, 4040101434, 4040100886, 4040100345, 4040099723, 4040099292, 4040098790, 4040098257, 4040097686, 4040097144, 4040096610, 4040096095, 4040095590, 4040095069, 4040094589, 4040094176, 4040093627, 4040093103, 4040092664, 4040092002, 4040091301, 4040090994, 4040090260, 4040090071, 4040114571, 4040106428, 4040103154, 4040102787, 4040101569, 4040100319, 4040099285, 4040098080, 4040097444, 4040096623, 4040096329, 4040093554, 4040093253, 4040092533, 4040092225, 4040091186, 4040090487, 4040090127, 4040089097, 4040088072, 4040087304, 4040086396, 4040086008, 4040085248, 4040081952, 4040081430, 4040080682, 4040079977, 4040078321, 4040077994, 4040076008, 4040075727, 4040075019, 4040073944, 4040072973, 4040069928, 4040069404, 4040067649, 4040066722, 4040066346, 4040065681, 4040065384, 4040064601, 4040064338, 4040063722, 4040062876, 4040062137, 4040061860, 4040060566, 4040059440, 4040059130, 4040058408, 4040057417, 4040056701, 4040056327, 4040055648, 4040055371, 4040054668, 4040054302, 4040053339, 4040053073, 4040052479, 4040051529, 4040051218, 4040050367, 4040049898, 4040049477, 4040048860, 4040048610, 4040047200, 4040046306, 4040045963, 4040044610, 4040044335, 4040043510, 4040043018, 4040041905, 4040040986, 4040040698, 4040040081, 4040038204, 4040037632, 4040037229, 4040034833, 4040033509, 4040032649, 4040032387, 4040031929, 4040031711, 4040030960, 4040030026, 4040029645, 4040029324, 4040028547, 4040028126, 4040027995, 4040027553, 4040027234, 4040026512, 4040025383, 4040025125, 4040024723, 4040024369, 4040024078, 4040023762, 4040019598, 4040019322, 4040018926, 4040012645, 4040012415, 4040012232, 4040011907, 4040011555, 4040011357, 4040015753, 4040015587, 04GRMVDY, 04GRMTXC, 04GRMTKH, 04GRMTBN, 04GRJVTS, 04GRJSYC, 04GRMKNQ, 04GRMHDN, 04GRMGWP, 04GRMFBH, 04GRMCXN, 04GRMBZD, 04GRMBVJ, 04GRMBFD, 04GRLZZK, 04GRLKWN, 04GRLKSC, 04GRLKBN, 04GRJNRG, 04GRHRKH, 04GRFDYH, 04GRDHSZ, 04GRCFJR, 04GRBLLM, 04GRBHKM, 04BZYLZX, 04BZYKFF, 04BZYHVY, 04BZYGRV, 04BZYFXP, 04BZSLLY, 04BZSKTS, 04GRKHLG, 04GRKHKH, 04GRKGYM, 04GRKGWN, 04GRKGFV, 04BZYNQZ, 04BZYRKJ, 04BZYRHN, 04BZYRDY, 04BZYRBN, 04BZYMPT, 04BZYMMR, 04BZYMHJ, 04BZYMDC, 04BZZLNM, 04BZZLKG, 04BZZLGD, 04BZZKZR, 04BZZKRX, 04BZZKPG, 04BZZKMS, 04BZZKGX, 04BZZJZT, 04BZZHBG, 04BZZGXR, 04BZZGKP, 04BZZGFF, 04BZZFXP, 04BZYNVM, 04BZYNJF, 04BZYNFP, 04BZZFVR, 04BZZFQV, 4040114571, 4040106428, 4040103154, 4040102787, 4040101569, 4040100319, 4040099285, 4040098080, 4040097444, 4040096623, 4040096329, 4040093554, 4040093253, 4040092533, 4040092225, 4040091186, 4040090487, 4040090127, 4040089097, 4040088072, 4040087304, 4040086396, 4040086008, 4040085248, 4040081952, 4040081430, 4040080682, 4040079977, 4040078321, 4040077994, 4040076008, 4040075727, 4040075019, 4040073944, 4040072973, 4040069928, 4040069404, 4040067649, 4040066722, 4040066346, 4040065681, 4040065384, 4040064601, 4040064338, 4040063722, 4040062876, 4040062137, 4040061860, 4040060566, 4040059440, 4040059130, 4040058408, 4040057417, 4040056701, 4040056327, 4040055648, 4040055371, 4040054668, 4040054302, 4040053339, 4040053073, 4040052479, 4040051529, 4040051218, 4040050367, 4040049898, 4040049477, 4040048860, 4040048610, 4040047200, 4040046306, 4040045963, 4040044610, 4040044335, 4040043510, 4040043018, 4040041905, 4040040986, 4040040698, 4040040081, 4040038204, 4040037632, 4040037229, 4040034833, 4040033509, 4040032649, 4040032387, 4040031929, 4040031711, 4040030960, 4040030026, 4040029645, 4040029324, 4040028547, 4040028126, 4040027995, 4040027553, 4040027234, 4040026512, 4040025383, 4040025125, 4040024723, 4040024369, 4040024078, 4040023762, 4040019598, 4040019322, 4040018926, 4040012645, 4040012415, 4040012232, 4040011907, 4040011555, 4040011357, 04GRJVKG, 04GRMLDC, 04GRMHBL, 4040012183, 4040012052
RECALLING FIRM/MANUFACTURER
CSL Plasma, Lexington, KY, by facsimile or electronic notification on February 11, 2010, February 12, 2010, or March 16, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred for a history of high risk behavior, were distributed
VOLUME OF PRODUCT IN COMMERCE
398 units
DISTRIBUTION
Germany, Switzerland, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0614-11
CODE
Unit:12FS46403
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 1, 2008 and by letter on May 2, 2008.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Durham, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0616-11
CODE
Unit: 012KZ41356
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 7, 2008 and by letter on May 8, 2008.
Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Raleigh, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0617-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0618-11
CODE
1) Units: 7486308 Part A, 7486308 Part B;
2) Units: 7212889; 7246886
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on May 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0619-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0620-11
CODE
1) and 2) 041FE36315
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by fax on September 10, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0623-11
CODE
Unit: 4235443
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 8, 2001.
Manufacturer: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0625-11
CODE
Unit: W067110033687
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on October 19, 2010 and follow-up letter on November 3, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland; LA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0626-11
CODE
Unit: W091010213869
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, by telephone on October 20, 1010 and by letter on October 29, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with required specifications, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0627-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0628-11
CODE
1) and 2) Unit: W091010201280
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on October 11, 1010, fax on October 18, 2010 and October 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, OK
___________________________________
PRODUCT
Source Plasma. Recall # B-0630-11
CODE
Units: 3960075253; 3960083632; 3960074581; 3960074467
RECALLING FIRM/MANUFACTURER
International Bioresources, LLC, Brownsville, TX, by facsimile on November 5, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0715-11
CODE
Unit: 12GM63987
RECALLING FIRM/MANUFACTURER
Recalling Firm:The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on September 9, 2010 and letter on October 31, 2010.
Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PR
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0253-11
CODE
Units: 011KM38645
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on July 18, 2010 and letter on August 3, 2010 and by letter on September 7, 2010. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0354-11
CODE
Unit: W037909187447
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on March 08, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Plasma Frozen. Recall # B-0586-11
CODE
Unit: 02GG62395
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Tulsa, OK, by telephone on July 24, 2008 and by fax on July 28, 2008.
Manufacturer: American Red Cross, Dallas, TX. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0587-11
CODE
Unit: 4210032
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on July 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the antibiotic Trimethoprim, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0592-11
CODE
Unit: 49GV43537
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on August 3, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, OK, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0612-11
CODE
Units: 7653232 Part 1, 7653232 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on October 23, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete
REASON
Blood products, which were possibly contaminated with Diptheroid bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0613-11
CODE
Unit:12FS46403
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 1, 2008 and by letter on May 2, 2008.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Durham, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0615-11
CODE
Unit: 012KZ41356
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 7, 2008 and by letter on May 8, 2008.
Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Raleigh, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0621-11
CODE
Unit: 7667145
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on October 24, 2007 and by fax on October 25, 2007.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete
REASON
Blood product, which was possibly contaminated with Diptheroid bacilli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma Fresh Frozen. Recall # B-0622-1
CODE
Unit: 4235443
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 8, 2001.
Manufacturer: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK, Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0624-11
CODE
Unit: W067110033687
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on October 19, 2010 and follow-up letter on November 3, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0626-11
CODE
Unit: W091010213869
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on October 20, 1010, letter on October 29, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with required specification, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0629-11
CODE
Unit: W091010278350
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by telephone on October 11, 1010, fax on October 18, 2010 and October 28, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN, OK
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0675-11
CODE
Units: W050710461002, W050710461003, W050710461011, W050710461015
RECALLING FIRM/MANUFACTURER
Arundel Medical Center Blood Bank, Annapolis, MD, by letter dated October 4, 2010. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within eight hours of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-0714-11
CODE
Unit: 12GM63987
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on September 9, 2010 and letter on October 31, 2010.
Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PR
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030080150, AB14W035120150, AB14W035040150, AB14W030120150, AB14W025120150, AB14W040080150, AB14W040120150, AB14W040210150, AB14W030150150, AB14W025210150, AB14W020150150, AB14W025040150, AB14W040150150, AB14W035080150, AB14W020210150, AB14W035210150, AB14W025150150, AB14W030210150, AB14W035150150, AB14W040080090, Intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is an over the wire (OTW) 0.014" coaxial lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter shaft and the balloon has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter that terminates at the distal tip. This lumen is used to pass the catheter over a guide wire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. The 210mm balloon contains two additional radiopaque marker bands that denote the middle of the balloon body. Recall # Z-0789-2011
CODE
Lot Numbers: 8629968, 8630847, 8631564, 8657024, 8664384, 8664386, 8672990, 8672994, 8674379, 8703042, 8703044, 8703047, 8703049, 8703050, 8705822, 8710383, 8710423, 8711789, 8711873, 8722274, 8722275, 8722277, 8722279, 8737491, 8738444, 8741777, 8741778, 8741781, 8741786, 8741791, 8741794, 8743036, 8744140, 8745610, 8745612, 8745616, 8746781, 8746902, 8746903, 8747184, 8749882, 8749895, 8749899, 8749903, 8749908, 8751214, 8755401, 8755600, 8755601, 8755602, 8755603, 8755604, 8755622, 8755625, 8757061, 8757219, 8757468, 8778745, 8778748, 8778749, 8778807, 8778808, 8778810, 8778813, 8784853, 8784854, 8784858, 8784859, 8784860, 8784864, 8784866, 8787509, 8789883, 8789891, 8789924, 8789928, 8789931, 8789935, 8789939, 8789946, 8792133, 8792531, 8795994, 8795999, 8796001, 8796007, 8796008, 8798136, 8810467, 8810468, 8810470, 8810472, 8810473, 8810474, 8810475, 8811586, 8815365, 8815409, 8815410, 8815414, 8815676, 8816203, 8816467, 8816902, 8821338, 8821419, 8821428, 8821431, 8821432, 8821434, 8822411, 8822758, 8822880, 8822999, 8826331, 8826333, 8826336, 8826743, 8827208, 8827211, 8828189, 8836748, 8836749, 8836819, 8837761, 8837969, 8837970, 8838736, 8841532, 8842327, 8842537, 8846663, 8846664, 8847435, 8847440, 8847442, 8851945, 8853567, 8854221, 8871664, 8871667, 8871669, 8873813, 8877645, 8877650, 8915544, 8916474, 8964937, 8970943, 8970944, 8985597, 8985601, 8989918, 8989919, 9000723, 9013770, 9018516, 9023719, 9023725, 9023729, 9050028, 9062683, 9074214, 9078464, 9082516, 9082532, 9083740, 9088260, 9097147, 9097148, 9097149, 9097151, 9146365, 9148256, 9153520, 9153521, 9153523, 9155514, 9178997, 9179000, 9180316, 9194250, 9194251, 9195071, 9198871, 9203512, 9204433, 9208439, 9208441, 9209447, 9209680, 9209903, 9209927, 9214883, 9216747, 9216811, 9216848, 9217289, 9218102, 9220075, 9221177, 9221180, 9221182, 9221183, 9221817, 9222820, 9222907, 9222934, 9224246, 9224585, 9225648, 9231360, 9231361, 9232283, 9232658, 9233059, 9235612, 9235780, 9235807, 9235823, 9237412, 9237413, 9238413, 9238795, 9245449, 9248425, 9248553, 9248574, 9248597, 9251552, 9254604, 9254782, 9254886, 9263037, 9263491, 9266768, 9270248, 9283623, 9286249, and 9286411
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter dated November 10, 2010. Firm initiated recall is ongoing.
REASON
ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in material separation and potential embolization.
VOLUME OF PRODUCT IN COMMERCE
4,962 (3,858 US, 1,104 OUS)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U Indicated for refractory left ventricular hear failure, cardiogenic shock, unstable refractory angina, mechanical complication due to acute myocardial infarction, impending infarction, ischemia related intractable ventricular arrhythmia, septic shock, support for failed angioplasty and valvuloplasty, and cardiac support for high risk general surgical patients. Recall # Z-0790-2011;
2) Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U Indicated for refractory left ventricular hear failure, cardiogenic shock, unstable refractory angina, mechanical complication due to acute myocardial infarction, impending infarction, ischemia related intractable ventricular arrhythmia, septic shock, support for failed angioplasty and valvuloplasty, and cardiac support for high risk general surgical patients. Recall # Z-0791-2011;
3) FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS Indicated for refractory left ventricular hear failure, cardiogenic shock, unstable refractory angina, mechanical complication due to acute myocardial infarction, impending infarction, ischemia related intractable ventricular arrhythmia, septic shock, support for failed angioplasty and valvuloplasty, and cardiac support for high risk general surgical patients. Recall # Z-0792-2011;
4) FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS Indicated for refractory left ventricular hear failure, cardiogenic shock, unstable refractory angina, mechanical complication due to acute myocardial infarction, impending infarction, ischemia related intractable ventricular arrhythmia, septic shock, support for failed angioplasty and valvuloplasty, and cardiac support for high risk general surgical patients. Recall # Z-0793-2011
CODE
1) Lot Numbers: KF0087756 MF9014573 MF9025207 MF9025208 MF9025213 MF9025226 MF9025227 MF9035382 MF9035448 MF9088501 MF9099356 MF9099357 MF9099358 MF9099359 MF9110054 MS9057152 MS9057153 MS9109664 MS9110295 MS9110368 MF9067735 MF9067736 MF9077955 MF9077968 MF9077969 MF9078203 MF9078343 MF0053017 MF0053018 MF0053019 MF0073778 MF0074136 MF0074137 MS9056710;
2) Lot Numbers: KF0087855 KF0087856 MF9014575 MF9014817 MF9024965 MF9024993 MF9025112 MF9025209 MF9035509 MF9035685 MF9088685 MF9100025 MS9056857 MS9057154 MS9110263 MS9110269 MS0053114 MF9035955 MF9046057 MF9046247 MF9046501 MF9056746 MF9057069 MF9057070 MF0011189 MF0021654 MF0042406 MF0042501 MF0042786 MF9067275 MF9067738 MF9077954 MF9078048 MF9078052 MF9078348 MF9078349 MF0053023 MF0063353 MF0073903 MF0074071, and MS9056684;
3) Lot Numbers: KF0097980 KF0097981 KF0097982 MF9025252 MF9025253 MF9025254 MF9025255 MF9025320 MF9025322 MF9035383 MF9035385 MF9035611 MF9035612 MF9088679 MF9088680 MF9099229 MF9099230 MF9099231 MF9099232 MF9099233 MF9099310 MF9099353 MF9100006 MF9100007 MF9109757 MF9109758 MF9110055 MF9110192 MF9110303 MF9110304 MF9110305 MS9056811 MS9109705 MS9109708 MF9035835 MF9035954 MF9056741 MF9056846 MF9057067 MF9057068 MF0011388 MF0021613 MF0021614 MF0021615 MF0021616 MF0031841 MF0031842 MF0032167 MF0042783 MF0042784 MF0042785 MF9067348 MF9067349 MF9067737 MF9077887 MF9077970 MF9077972 MF9078195 MF9078196 MF9078197 MF9078198 MF9078200 MF9078344 MF9078345 MF9078346 MF9078347 MF0053022 MF0063352 MF0073779 MF0073902 MF0074070 MS9056709, and MS9056810;
4) Lot Numbers: KF0087765 KF0087766 KF0087857 KF0087858 MF9014819 MF9024960 MF9025107 MF9025108 MF9025109 MF9025110 MF9025111 MF9025117 MF9025118 MF9025145 MF9025158 MF9025166 MF9025167 MF9025210 MF9035386 MF9035449 MF9035450 MF9035451 MF9035613 MF9035614 MF9035695 MF9078364 MF9088681 MF9088682 MF9088683 MF9088684 MF9088779 MF9088780 MF9099197 MF9099198 MF9099199 MF9099311 MF9099312 MF9099354 MF9099355 MF9109756 MF9109824 MF9109825 MF9109970 MF9110191 MF9110244 MF9110245 MF9110300 MF9110301 MF9110520 MF9110521 MF9120677 MF9120678 MF9120749 MF0010929 MF0010930 MF0010931 MS9056853 MS9056854 MS9056855 MS9109707 MS9109709 MF9035696 MF9035697 MF9035698 MF9035748 MF9035836 MF9035837 MF9035957 MF9035958 MF9046058 MF9046096 MF9046097 MF9046203 MF9046204 MF9046205 MF9046243 MF9046403 MF9046404 MF9046405 MF9046406 MF9046407 MF9046502 MF9046548 MF9046549 MF9046550 MF9046551 MF9056744 MF9056745 MF9056847 MF9056848 MF9056936 MF9056937 MF9056938 MF9056939 MF9056940 MF9057071 MF9057072 MF9057171 MF9067269 MF9067270 MF0010932 MF0011098 MF0011099 MF0011184 MF0011185 MF0011327 MF0011328 MF0011329 MF0021481 MF0021482 MF0021582 MF0021583 MF0021584 MF0021585 MF0021655 MF0021656 MF0031800 MF0031801 MF0031802 MF0031920 MF0032013 MF0032014 MF0032015 MF0032113 MF0032114 MF0042360 MF0042361 MF0042393 MF0042394 MF0042395 MF0042502 MF0042503 MF0042779 MF0042780 MF0042781 MF0042782 MF0053006 MF0053007 MF0053008 MF0053009 MF9067271 MF9067272 MF9067273 MF9067332 MF9067350 MF9067351 MF9067487 MF9067488 MF9067575 MF9067576 MF9067577 MF9067631 MF9067739 MF9067740 MF9067741 MF9067742 MF9077888 MF9077889 MF9077890 MF9077893 MF9078350 MF9078351 MF9078352 MF9078353 MF9078354 MF9078361 MF9078362 MF9078363 MF0053233 MF0053234 MF0063366 MF0063368 MF0063419 MF0063420 MF0063441 MF0063472 MF0063594 MF0063595 MF0073845 MF0073846 MF0073847 MF0073848 MF0073850 MF0073851 MF0073852 MF0073853 MF0073854 MF0073855 MF0073856 MF0073955 MF0073956 MF0074046 MF0074047 MF0074072 MF0074130 MF0074131 MF0074132 MF0074133 MF0074134 MS9046468 MS9046478 MS9046479 MS9056585 MS9056586 MS9056679, and MS9056707
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International, Inc., Division of Teleflex Medical Inc., Everett, MA, by letter on October 11, 2010.
Manufacturer: Arrow Internacional de Chihuahua S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
IAB catheter becomes stuck in the sheath and is unable to move forward or backward, causing a delay therapy, bleeding or arterial injury.
VOLUME OF PRODUCT IN COMMERCE
35,861 units
DISTRIBUTION
Nationwide, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia. Madrid, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Columbia, Ecuador, India, Indonesia, Japan, Korea Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela
___________________________________
PRODUCT
Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592. Z-0837-2011
CODE
None
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Carrollton, TX, by letter on August 24, 2010. Firm initiated recall is ongoing.
REASON
Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.
VOLUME OF PRODUCT IN COMMERCE
1,432 Pumps
DISTRIBUTION
VA, NY
___________________________________
PRODUCT
1) Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9. Recall # Z-0843-2011;
2) Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7. Recall # Z-0844-2011
CODE
1) Lot numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102, 10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180;
2) Lot numbers: 09JR01174, 09JR01229, 09NR01139, 10KR01801
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated November 19, 2010.
Manufacturer: Fresenius Medical Care, Reynosa, Tamulipas, Mexico. Firm initiated recall is ongoing.
REASON
Hemodialysis Blood tubing Sets may develop kinking of the arterial line
VOLUME OF PRODUCT IN COMMERCE
190,080 units (code 03-2695-9); 10,032 (code 03-2795-7)
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects. Recall # Z-0007-2011
CODE
Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by letter and visit beginning September May 1, 2009. Firm initiated recall is ongoing.
REASON
It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.
VOLUME OF PRODUCT IN COMMERCE
45 units (13 Nationwide)
DISTRIBUTION
ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia
___________________________________
PRODUCT
Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator. Targeting, detecting heated areas, searches. Recall # Z-0507-2011
CODE
All units
RECALLING FIRM/MANUFACTURER
Amstech Inc., Alpharetta, GA, by letter dated August 5, 2010. Firm initiated recall is ongoing.
REASON
Product contains infra red laser, which can pose a potential hazard to users who unknowingly shine the beam into people's eyes.
VOLUME OF PRODUCT IN COMMERCE
Unknown (all units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9. Recall # Z-0622-2011
CODE
Lot number: E06831 (Exp 8/2012); The lot number on the 3 ct cartons may be followed by an "N" or "S", for example, E06831 "N" or E06831 "S”
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Global, Madison, NJ, by letter dated September 24, 2010.
Manufacturer: Wyeth Consumer Healthcare, Albany, GA. Firm initiated recall is ongoing.
REASON
The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.
VOLUME OF PRODUCT IN COMMERCE
192,000 cartons (570000 wraps)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vacuette 2 ml Lithium Heparin, Collection Tube. Venous blood collection tubes. Item number: 454237. Recall # Z-0623-2011
CODE
Lot number: B061006
RECALLING FIRM/MANUFACTURER
Greiner Bio-One North America, Inc., Monroe, NC, by letter on August 25, 2010. Firm initiated recall is complete.
REASON
Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE
18 cases (total 21,600 pieces)
DISTRIBUTION
CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI
___________________________________
PRODUCT
ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301. The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes. Recall # Z-0628-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter dated February 19, 2010.
Manufacturer: Minntech Corp., Plymouth, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a possible temperature monitoring system malfunction. This recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and result in reported incidents of respiratory reactions, dizziness, burning eyes and headaches to the healthcare worker.
VOLUME OF PRODUCT IN COMMERCE
1,881 units
DISTRIBUTION
Nationwide and countries of Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria
___________________________________
PRODUCT
ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent micro-particle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; list 1P30-25 The ARCHITECT iVancomycin assay is an in vitro chemiluminescent micro-particle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy. Recall # Z-0629-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, letters dated September 13 and 15, 2010.
Manufacturer: Biokit Sa, Llica d'Amunt. Spain. Firm initiated recall is ongoing.
REASON
The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.
VOLUME OF PRODUCT IN COMMERCE
2,411 kits
DISTRIBUTION
Nationwide and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam
___________________________________
PRODUCT
SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative. Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498. Recall # Z-0716-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Patterson Dental Supply, Inc., Saint Paul, MN, by letter dated October 15, 2010.
Manufacturer: Kerr/Pentron Dba Kerr Corporation And Pentron Clinical, Orange, CA. Firm initiated recall is ongoing.
REASON
Some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product.
VOLUME OF PRODUCT IN COMMERCE
3,204 units
DISTRIBUTION
Nationwide except VT
___________________________________
PRODUCT
1) HiSpeed LXI (2200997). Recall # Z-0744-2011;
2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011;
3) HiSpeed DX/I (2201000). Z-0746-2011;
4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011;
5) HiSpeed DX/I (2249696). Recall # Z-0768-2011;
6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011;
7) HiSpeed FX/I (2200997 with Gantry mo. #2200997). Recall # Z-0771-2011;
8) HiSpeed FX/I (2200997 with Gantry mo. #2201000). Recall # Z-0772-2011;
9) HiSpeed FX/I (2200997 with Gantry mo. #2200997-2). Recall # Z-0773-2011;
10) HiSpeed FX/I (2200997 with Gantry mo. #2201000-2). Recall # Z-0774-2011;
11) HiSpeed FX/I (2200997 with Gantry mo. #2249696). Recall # Z-0775-2011;
12) HiSpeed FX/I (2200997 with Gantry mo. #2249696-2). Recall # Z-0776-2011;
13) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997). Recall # Z-0777-2011;
14) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2). Recall # Z-0778-2011;
15) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000). Recall # Z-0779-2011;
16) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2). Recall # Z-0780-2011;
17) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696). Recall # Z-0781-2011;
18) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2). Recall # Z-0782-2011;
19) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997). Recall # Z-0783-2011;
20) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2). Recall # Z-0784-2011;
21) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000). Recall # Z-0785-2011;
22) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2). Recall # Z-0786-2011;
23) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696). Recall # Z-0787-2011;
24) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2). Recall # Z-0788-2011
CODE
With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on February 1, 2010. Firm initiated recall is ongoing.
REASON
A defect with the hardware and software displaying the incorrect dose data.
VOLUME OF PRODUCT IN COMMERCE
102 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
klinoPORT, AC powered Operating Table. Model number: klinoPORT 706, 806, 906, 1006 and 1306. Recall # Z-0802-2011
CODE
Serial number between: 101039290 and 101158669
RECALLING FIRM/MANUFACTURER
Kreuzer Gmbh & Co. KG, Puchheim, Germany, by letter on/about October 26, 2010. Firm initiated recall is ongoing.
REASON
The motorized adjustable pendant arm may suddenly descend to its lowest position.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA, MA, MO
___________________________________
PRODUCT
1) ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. Recall # Z-0803-2011;
2) ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing. Recall # Z-0804-2011;
3) ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing. Recall # Z-0805-2011;
4) ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing. Recall # Z-0806-2011;
5) ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing. Recall # Z-0807-2011
CODE
1) Serial numbers range 05010100 – 1011176;
2) Serial numbers range 00040105 – 09031882;
3) Serial numbers range 0200101 – 06020501;
4) Serial numbers range 05010100 – 10111176;
5) Serial numbers range 05010100 - 10111779
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Bedford, MA, by letter on November 11, 2010. Firm initiated recall is ongoing.
REASON
Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
VOLUME OF PRODUCT IN COMMERCE
1059 units
DISTRIBUTION
Nationwide, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK
___________________________________
PRODUCT
Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO. Recall # Z-0808-2011
CODE
Lot Serial Number Range is 615445001 - 669783001 (The Lot Serial Number is comprised of nine digits. The first 6 digits represent the parent lot number, followed by the last 3 digits which represents the serial number). All lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013.
RECALLING FIRM/MANUFACTURER
American Medical Systems, Inc., Minnetonka, MN, by letter dated September 7, 2010. Firm initiated recall is ongoing.
REASON
Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.
VOLUME OF PRODUCT IN COMMERCE
7,069 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. Recall # Z-0809-2011;
2) Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. Recall # Z-0810-2011;
3) Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. Recall # Z-0811-2011;
4) Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. Recall # Z-0812-2011
CODE
1) Lot/Batch Numbers: 7860533, 7982702 and 7983132;
2) Lot/Batch Numbers: 7441839 and 7442099;
3) Lot/Batch Numbers: 7860533 and 7983132;
4) Lot/Batch Number: 7442099
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Marlborough, MA, by letter on October 20, 2010.
Manufacturer: Phillips Plastics Corporation, Phillips Medical, Menomonie, WI. Firm initiated recall is ongoing.
REASON
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
VOLUME OF PRODUCT IN COMMERCE
567 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. Recall # Z-0814-2011
CODE
Serial #'s 110019 110254 110299 110327 110024 110271 110300 110328 110051 110277 110303 110329 110056 110278 110308 110330 110091 110281 110309 110332 110092 110283 110310 110333 110174 110284 110311 110335 110202 110285 110313 110336 110243 110288 110318 110337 110251 110293 110326, and 110339
RECALLING FIRM/MANUFACTURER
TomoTherapy Inc., Madison, WI, by letter dated November 8, 2010. Firm initiated recall is ongoing.
REASON
TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.
VOLUME OF PRODUCT IN COMMERCE
40 (21 US; 19 OUS)
DISTRIBUTION
AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of Malaysia, Switzerland, Korea, Italy, Spain, Canada, Taiwan, Japan, Belgium
___________________________________
PRODUCT
CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; Straight Rasp Handle - Catalog number 1440-1400; & Specialty Head Center Accolade Broach Handle- Catalog number I-H088HF00, I-H1389HF00; Stryker Howmedica Osteonics, Non-sterile Instruments. Recall # Z-0815-2011
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated November 2010. Firm initiated recall is ongoing.
REASON
The CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach Handle may fracture in two pieces along the width of the body under the striking plate. This may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site
VOLUME OF PRODUCT IN COMMERCE
459 units
DISTRIBUTION
Nationwide, Canada, Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin Ameri ___________________________________
PRODUCT
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29. Recall # Z-0821-2011
CODE
Units: H140025 H140753 H140845 H140896 H272157 H27293 H291040 H291187 H293443 H293691
H140038 H140769 H140846 H140901 H272158 H272981 H291048 H291190 H293447 H293696 H140045 H140772 H140848 H140902 H272165 H272982 H291050 H291206 H293475 H140780 H140851 H182012 H272188 H273065 H291060 H291234 H293519 H293726 H140096 H140781 H140853 H271167 H272216 H273162 H291067 H291242 H293538 H293727 H140097 H140783 H140854 H271370 H272220 H273170 H291072 H291247 H293541 H293728 H140122 H140787 H140855 H271378 H272231 H273202 H291081 H291248 H293560 H293736 H140124 H140790 H140856 H271385 H272309 H273203 H291084 H291251 H293565 H293737 H140125 H140794 H140857 H271531 H272310 H290278 H291088 H291253 H293577 H293749 H140144 H140795 H140858 H271588 H272325 H290282 H291096 H291254 H293581 H293769 H140146 H140797 H140863 H271607 H272360 H290362 H291099 H291262 H293592 H293773 H140148 H140799 H140864 H271618 H272377 H290399 H291107 H291270 H293596 H293774 H140201 H140800 H140865 H271662 H272401 H290400 H291115 H291271 H293611 H293775 H140202 H140801 H140866 H271663 H272426 H290402 H291116 H291272 H293624 H293778 H140206 H140808 H140867 H271729 H272427 H290501 H291117 H293312 H293627 H293779 H140214 H140812 H140868 H271785 H272440 H290503 H291118 H293325 H293632 H293780 H140216 H140816 H140869 H271825 H272456 H290510 H291119 H293327 H293636 H293781 H140218 H140817 H140871 H271890 H272473 H290512 H291124 H293335 H293638 H293790 H140222 H140818 H140874 H271906 H272491 H290519 H291133 H293342 H293642 H293802 H140223 H140819 H140876 H271926 H272497 H291007 H291136 H293353 H293644 H293804 H140224 H140820 H140877 H271941 H272500 H291008 H291138 H293361 H293646 H293805 H140233 H140824 H140881 H271951 H272826 H291011 H291143 H293363 H293649 H293818 H140240 H140826 H140882 H271954 H272834 H291014 H291149 H293370 H293650 H293820 H140718 H140829 H140883 H271994 H272842 H291017 H291154 H293379 H293652 H293825 H140719 H140830 H140886 H272000 H272873 H291019 H291159 H293401 H293653 H293829 H140721 H140832 H140887 H272014 H272885 H291021 H291169 H293411 H293657 H293830 H140741 H140836 H140889 H272016 H272908 H291022 H291170 H293414 H293662 H293835 H140742 H140840 H140891 H272029 H272910 H291025 H291171 H293431 H293663 H293839 H140747 H140841 H140892 H272064 H272933 H291028 H291172 H293433 H293664 H293841 H140749 H140843 H140893 H272081 H272946 H291035 H291178 H293438 H293686 H293846 H140751 H140844 H140895 H272111 H272960 H291037 H291184 H293439 H293690 H293847 H293848 H294007 H294135 H294244 H294332 H294415 H294500 H294567 H294656 H294732 H293860 H294012 H294140 H294246 H294338 H294418 H294501 H294568 H294657 H294735 H293866 H294013 H294141 H294248 H294340 H294420 H294505 H294569 H294658 H294739 H293872 H294020 H294146 H294252 H294342 H294423 H294508 H294571 H294660 H294742 H293875 H294022 H294149 H294256 H294343 H294425 H294509 H294572 H294661 H294744 H293878 H294023 H294150 H294263 H294345 H294426 H294513 H294573 H294665 H294745 H293880 H294024 H294155 H294264 H294347 H294427 H294514 H294581 H294666 H294747 H293886 H294032 H294157 H294265 H294348 H294429 H294517 H294587 H294667 H294750 H293888 H294033 H294158 H294266 H294350 H294430 H294518 H294589 H294668 H294752 H293889 H294035 H294162 H294267 H294351 H294431 H294520 H294590 H294671 H294753 H293890 H294037 H294163 H294268 H294352 H294433 H294521 H294591 H294674 H294754 H293899 H294043 H294164 H294272 H294355 H294434 H294523 H294593 H294675 H294758 H293902 H294048 H294166 H294278 H294362 H294436 H294524 H294594 H294676 H294761 H293903 H294053 H294167 H294279 H294363 H294437 H294528 H294595 H294678 H294762 H293906 H294055 H294169 H294282 H294364 H294438 H294530 H294598 H294679 H294763 H293908 H294057 H294171 H294284 H294366 H294443 H294531 H294603 H294681 H294766 H293909 H294061 H294176 H294290 H294369 H294447 H294534 H294604 H294682 H294768 H293917 H294062 H294178 H294292 H294370 H294449 H294535 H294608 H294683 H294770 H293918 H294070 H294179 H294295 H294371 H294450 H294536 H294613 H294684 H294771 H293919 H294081 H294180 H294296 H294373 H294460 H294537 H294614 H294694 H294782 H293925 H294082 H294188 H294297 H294376 H294461 H294538 H294615 H294696 H294786 H293928 H294083 H294190 H294300 H294381 H294465 H294539 H294616 H294697 H294792 H293946 H294087 H294200 H294302 H294382 H294468 H294540 H294618 H294698 H294793 H293947 H294099 H294202 H294303 H294385 H294469 H294541 H294620 H294701 H294796 H293952 H294100 H294203 H294306 H294386 H294470 H294542 H294621 H294705 H294797 H293953 H294102 H294204 H294307 H294387 H294472 H294545 H294623 H294707 H294798 H293954 H294104 H294206 H294311 H294393 H294474 H294546 H294625 H294711 H294801 H293955 H294105 H294207 H294316 H294394 H294476 H294547 H294626 H294712 H294803 H293957 H294106 H294210 H294317 H294395 H294477 H294548 H294630 H294715 H294806 H293960 H294111 H294212 H294319 H294397 H294478 H294549 H294632 H294716 H294807 H293964 H294114 H294213 H294320 H294398 H294479 H294550 H294637 H294719 H294808 H293971 H294118 H294215 H294321 H294401 H294482 H294551 H294640 H294720 H294813 H293981 H294122 H294216 H294322 H294402 H294488 H294552 H294643 H294723 H294815 H293984 H294126 H294219 H294325 H294403 H294493 H294553 H294644 H294724 H294826 H293989 H294128 H294224 H294326 H294404 H294494 H294554 H294645 H294726 H294827 H293993 H294130 H294227 H294329 H294406 H294497 H294556 H294646 H294727 H294829 H294002 H294133 H294232 H294330 H294409 H294498 H294557 H294652 H294728 H294004 H294134 H294238 H294331 H294414 H294499 H294565 H294654 H294729
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Inc., Palo Alto, CA, by letters dated July 20, 2010.
Manufacturer: Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA. Firm initiated recall is ongoing.
REASON
The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.
VOLUME OF PRODUCT IN COMMERCE
708 units
DISTRIBUTION
Nationwide, Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia
___________________________________
PRODUCT
BD Beaver Slit Blade 3.0mm Straight Part Number: 375521. The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery. Recall # Z-0822-2011
CODE
Lot # 9138996, Exp: 2014-05
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Medical Systems, Waltham, MA, letter dated June 24, 2010.
Manufacturer: Becton Dickinson and Co. Waltham, MA. Firm initiated recall is ongoing.
REASON
Blades may contain defects at the blade tip or cutting edge.
VOLUME OF PRODUCT IN COMMERCE
524 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Steris Reliance EPS Endoscope Processing System. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices. Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081. Recall # Z-0823-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letters dated July 2, 2010.
Manufacturer: Steris Canada, Beauport, Canada. Firm initiated recall is ongoing.
REASON
Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.
VOLUME OF PRODUCT IN COMMERCE
936 units
DISTRIBUTION
Nationwide, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudi Arabia, Spain, Turkey, United Arab Emirates and United Kingdom
___________________________________
PRODUCT
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50. A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimmer Natural Nail system. Recall # Z-0824-2011
CODE
Lot Numbers: 00111903 and 07890923
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letters via e-mail on October 29, 2010. Firm initiated recall is ongoing.
REASON
The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. The manufacturing process created a step in the lumen which impedes the Lag Screw Retaining Shaft from passing through the lumen without the use of excessive force.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
MI, NJ, MS, OR, KS, TN, A, UT, and CA and countries of Belgium and Germany, Spain, Italy, Greece, France, UK, and Switzerland
___________________________________
PRODUCT
CLP Instrumentation Removal Hook, distributed by DJO Surgical, Device Listing Number: A776463. Device Part Number: 803-08-033. Recall # Z-0828-2011
CODE
Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, letter dated November 10, 2010. Firm initiated recall is ongoing.
REASON
Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI
___________________________________
PRODUCT
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI). Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat. Recall # Z-0831-2011
CODE
Serial Numbers: LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and LXI-034741
RECALLING FIRM/MANUFACTURER
Sunrise Medical Inc., Fresno, CA, by letter, dated February 2009. Firm initiated recall is complete.
REASON
The stabilizer bar was inadvertently omitted during the manufacturing process.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System. Recall # Z-0832-2011
CODE
Units: GW469, GW470, GW468, GW472
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galil Medical, Arden Hills, MN, by letter dated September 30, 2010,
Manufacturer: Galil Medical Ltd., Yokneam, Israel. Firm initiated recall is ongoing.
REASON
The products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Galil relabels the device for a different use, there are no changes made to the device and a faulty power cord plug still has the potential to affect the device as sold by Galil.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, GA, TX, and Canada
___________________________________
PRODUCT
Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient. Recall # Z-0833-2011
CODE
Diode only: serial numbers CDF00000001 thru CDG00001052; Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744
RECALLING FIRM/MANUFACTURER
Ohio Medical Corp., Gurnee, IL, by letters dated November 4, 2010. Firm initiated recall is ongoing.
REASON
The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.
VOLUME OF PRODUCT IN COMMERCE
4,183 units
DISTRIBUTION
Nationwide, Puerto Rico, and the countries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam
___________________________________
PRODUCT
Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202. Recall # Z-0845-2011
CODE
Lot Numbers: F62328, G11073, G11135, G11205, G11271, G11368, F62370, G11074, G11138, G11208, G11273, G11370, G10831, G11075, G11139, G11209, G11274, G11371, G10874, G11076, G11140, G11210, G11275, G11374, G10889, G11079, G11144, G11211, G11276, G11376, G10915, G11081, G11146, G11212, G11279, G11379, G10928, G11082, G11147, G11213, G11280, G11381, G10939, G11084, G11149, G11214, G11281, G11385, G10940, G11086, G11151, G11216, G11283, G11386, G10949, G11087, G11152, G11217, G11284, G11567, G10951, G11088, G11153, G11218, G11285, G11604, G10953, G11090, G11154, G11219, G11287, G11698, G10962, G11093, G11155, G11223, G11289, G11741, G10965, G11094, G11157, G11224, G11293, J10184, G10967, G11095, G11165, G11225, G11294, J10185, G10969, G11098, G11166, G11228, G11295, J10186, G10971, G11100, G11171, G11229, G11297, J10187, G10987, G11101, G11172, G11230, G11298, J10188, G10995, G11102, G11173, G11233, G11303, J10189, G10996, G11106, G11175, G11235, G11304, J10190, G10997, G11109 ,G11176, G11238, G11307, J10191, G11007, G11111, G11177, G11239, G11310, J10192, G11009, G11112, G11180, G11242 ,G11314, J10193 ,G11010, G11114, G11182, G11244, G11315, J10194, G11025, G11115, G11184, G11246, G11316, J10195, G11027 ,G11117, G11185, G11249, G11318, J10196, G11032, G11118, G11186, G11251, G11325, J10219, G11034, G11121, G11187, G11253, G11326, G10946, G11044, G11122, G11191, G11256, G11327, G11062, G11050, G11126, G11192, G11258 ,G11328, G11369, G11053, G11127, G11193, G11262, G11332, G11054, G11128, G11194, G11263, G11333, G11055, G11129, G11195, G11265, G11335, G11065, G11131, G11198, G11268, G11350, G11068, G11132, G11199, G11269, G11356, G11071, G11133, G11200, G11270, G11364
RECALLING FIRM/MANUFACTURER
Micrus Endovascular Corp., San Jose, CA, by letters dated October 21, 2010. Firm initiated recall is ongoing.
REASON
The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.
VOLUME OF PRODUCT IN COMMERCE
6,755 units
DISTRIBUTION
Nationwide and countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
___________________________________
PRODUCT
The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "Neusoft NeuViz Dual Multi-Slice CT Scanner System.” Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. Recall # Z-0846-2011
CODE
Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012
RECALLING FIRM/MANUFACTURER
Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China, by letter dated Feb. 10, 2010. Firm initiated recall is ongoing.
REASON
Potential for the CT patient table top to become detached from the carrier due to missing washers.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties. This recall impacts all products built for the affected product numbers (between September 2004- 10, 2010). Recall # Z-0847-2011;
2) Video Cart, Premium 120V product labeling is as follows: REF, VP6501, QTY1, Video Cart, Premium, 120V, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties. This recall impacts all products built for the affected product numbers (between September 2004- 10, 2010). Recall # Z-0848-2011;
3) Video Cart Multi-Specialty product labeling is as follows: REF, VP6502, QTY1, Video Cart Multi-Specialty, 120V, Rx ONLY, These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties. This recall impacts all products built for the affected product numbers (between September 2004- 10, 2010). Recall # Z-0849-2011;
4) Video Cart Articulating Arm product labeling is as follows: REF, VP6504, QTY1, Video Cart Articulating Arm, Rx ONLY, These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties This recall impacts all products built for the affected product numbers (between September 2004- 10, 2010). Recall # Z-0850-2011;
5) Video Cart, 120 VAC product labeling is as follows: REF, VP8500, QTY1, Video Cart, 120 VAC, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties. This recall impacts all products built for the affected product numbers (between September 2004- 10, 2010). Recall # Z-0851-2011
CODE
1) Lot Number: 1160 1533 1590 1959 2534 2558 2595 2724 2798 2905 3009 3269 3428 3831 4099 4498 4894 5209;
2) Serial Numbers: 04080101 04080201 04080301 04080401 04080501 04080601 04080701 04080801 04080901 04081001 04081101 04081201 04081301 04081401 04090101 04090201 04090301 04090501 04090601 04090701 04090801 04090901 04110101 04110201 04110301 04110401 04110501 04110601 04110701 04110801 04110901 04120101 04120201 04120301 04120401 04120501 04120601 04120701 04120801 04120901 05020101 05020201 05020301 05020401 05020501 05020601 05020701 05020801 05020901 05021001 05021101 05021201 05021301 05021401 05021501 05021601 05021701 05040101 05040301 05040401 05040501 05040601 05040701 05040801 05040901 05041001 05041101 05041201 05041301 05041401 05041501 05041601 05050101 05050201 05050301 05050401 05050501 05050601 05050701 05050801 05060101 05060201 05060301 05060401 05060501 05070101 05070201 05070301 05070401 05070501 05070601 05080101 05080201 05080301 05080401 05080501 05080601 05080701 05080801 05080901 05081001 05081101 05081201 05081301 05081401 05081501 05081601 05081701 05081801 05081901 05100101 05100201 05100301 05100401 05100501 05100601 05110101 05110201 05110301 05110401 05110601 05110701 05110801 05110901 05111001 05111101 05111201 05111301 05111401 05120101 05120201 05120301 05120401 05120501 05120601 05120701 05120801 05120901 05121001 06020101 06020201 06020301 06020401 06020501 06020601 06020701 06020801 06020901 06021001 06021101 06021201 06021301 06021401 06021501 06021601 06021701 06021801 06030101 06030201 06030301 06040101 06040201 06040301 06040401 06040501 06040601 06040701 06040801 06040901 06041001 06041101 06041201 06041301 06041401 06041501 06041601 06041701 06041801 06041901 06042001 06042101 06042201 06042301 06042401 06042501 06042601 06042701 06042801 06042901 06050101 06050201 06050301 06050401 06050501 06050601 06050701 06050801 06050901 06051001 06051101 06051201 06060101 06060201 06060301 06060401 06060501 06060601 06060701 06060801 06060901 06061001 06061101 06061201 06061301 06061401 06061501 06061601 06061701 06070101 06070201 06070301 06070401 06070501 06070601 06070701 06070801 06070901 06071001 06080101 06080201 06080301 06080401 06080501 06080601 06080701 06080801 06080901 06090101 06090201 06090301 06100101 06100201 06100301 06100401 06100501 06100601 06100701 06100801 06100901 06101001 06101101 06101201 06101301 06101401 06101501 06101601 06101701 06101801 06101901 06102001 06102101 06102201 06102301 06102401 06102501 06102601 06102701 06102801 06102901 06103001 06103101 06103201 06103301 06110101 06110201 06110301 06110401 06110501 06110601 06110701 06110801 06110901 06111001 06111101 06111201 06111301 06111401 06111501 07030101 07030201 07030301 07030401 07030501 07030601 07030701 07030801 07031001 07031101 07040101 07040201 07040301 07040401 07040501 07040601 07040701 07080101 07080201 07080301 07100101 07100201 07100301 07100401 07100501 07100601 07100701 07100801 07100901 07101001 07101101 07101201 07101301 07101401 07110101 07120101 07120201 07120301 07120401 07120501 08010101 08010201 08010301 08010501 08010601;
3) Serial #: 04090102 04090202 04090302 04090402 04090502 04090602 04090702 04090802 04090902 04091002 04091102 04091202 04091302 04091402 04091502 04091602 04091702 04110102 04110202 04110302 04110402 04110502 04110602 04110702 04110802 04110902 04111002 04111102 04111202 04111302 04111402 04111502 04111602 04111702 04111802 04111902 05030102 05030202 05030302 05030402 05030502 05030602 05030702 05030802 05030902 05031002 05031102 05031202 05031302 05031402 05031502 05031602 05031702 05031802 05031902 05050102 05050202 05050302 05050402 05050502 05050602 05050802 05050902 05051002 05060102 05060202 05060302 05070102 05070202 05070402 05070502 05070602 05080102 05080202 05080302 05080402 05080502 05080602 05080702 05090102 05090202 05090302 05090402 05090502 05090602 05090702 06020102 06020202 06020302 06020402 06020502 06020602 06020802 06020902 06021002 06040102 06040202 06040302 06040402 06040502 06050102 06050202 06050302 06050402 06050502 06050602 06050702 06050802 06050902 06070102 06070202 06070302 06070402 06070502 06070602 06080102 06080202 06080302 06080402 06080502 06080602 06080702 06080802 06080902 06081002 06090102 06090202 06090302 06090402 06090502 06090602 06090702 06090802 06090902 06091002 06091102 06091202 06100102 06100202 06100302 06100502 06100702 06100802 06100902 06101002 06101102 06110102 06110202 06110302 06110402 06110502 06110602 06110702 06110802 06110902 06111002 06111102 06111202 06111302 06111402 06111502 06111602 06111702 06111802 06120102 06120202 06120302 06120402 07120102 08010102 08010202 08010302 08010402;
4) Serial Number: 05080104 05080204 05080304 05080404 05080504 05080604 05080704 05080804 05090104 05090204 05090304 05090404 05090504 05090604 05090704 05090804 05090904 05091104 05091204 05110104 05120104 05120204 05120304 05120404 05120504 05120604 05120704 05120804 05120904 05121004 06020104 06020204 06020304 06020404 06020504 06020604 06030104 06030204 06030304 06030404 06040104 06040204 06040304 06040504 06040604 06040704 06040804 06040904 06041004 06060104 06060204 06060304 06060404 06060504 06070104 06070404 06070504 06070604 06080104 06080204 06080304 06080504 06080604 06090104 06090204 06090304 06090404 06090504 06090604 06100104 06100204 06100304 06100404 06100504 06100704 06100804 06100904 06101004 06101104 06101204 06101304 06101404 06110104 06110204 06110304 06110404 06110504 06110604 06110704 06110804 06110904 06111004 06120104 06120204 06120304 06120404 06120504 06120604 06120704 06120804 06120904 06121004 06121104 06121204 07070104 07070204 07070304 07070404 07070504 07070604 07070704 07070804 07070904 07071004 07071104 07080104 07080204 07080304 07080404 07080504 07100104 07100204 07100304 07100404 07100504 07100604 07100704 07100804 07100904 07101004 07110104 07110204 07110304 07110404 07110504 07110604 07110704 07110804 07110904 07111004 07111104 07111204 07111304 07120104 07120204 07120304 07120404 07120504 07120604 07120704 07120804 07120904 07121004 07121104 07121204 07121304 07121404 07121504 08010104 08010204 08010304 08010404 08010504 08010604;
5) Serial Number: 06030102R 06030106R 06080185R 06080285R 06080485R 06080585R 06080685R 06080785R 06080885R 06080985R 06081085 06081185R 06081285R 06081685R 06081785 06081785R 06081985R 06082185R 06082285R 06082385R 06082485R 06082585R 06082885R 06082985R 06083285R 06083385R 06083485R 06083885R 06083985R 06084085R 06090185R 06090285R 06090385R 06090485R 06090585R 06100185 06100285 06100385 06100485 06100585 06100685 06100785 06101185 06101285 06101385 06101485 06101585 06101685 06101785 06101885 06101985 06102085 06102185 06102285 06102385 06102485 06102585 06110185 06110285 06110385 06110485 06110785 06110885 06110985 06111085 06111185 06111285 06111385 06111485 06111585 06111685 06111785 06111885 06111985 06112085 06112185 06112285 06112385 06112485 06112585 06112685 06112785 06112885 06112985 06113085 06120185 06120285 06120385 06120485 06120685 06120785 06120885 06120985 06121185 06121285 06121385 06121485 06121585 06121685 06121785 06121885 06121985 06122085 06122185 06122285 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RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on February 23, 2010. Firm initiated recall is ongoing.
REASON
These products are being recalled due to there is a possibility that the Video Carts with retractable cord reels contain an Electric-cord plug, which may fail. Such a failure could potentially interrupt surgery and may cause sparking, charring or fire at the electrical wall socket.
VOLUME OF PRODUCT IN COMMERCE
1,761 carts
DISTRIBUTION
Nationwide and countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela
___________________________________
PRODUCT
Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile. Used for temporary internal drainage from the ureteropelvic junction to the bladder. Recall # Z-0852-2011
CODE
Lot number: U1987598
RECALLING FIRM/MANUFACTURER
Vance Products Inc., Spencer, IN, by letter dated October 18, 2010. Firm initiated recall is ongoing.
REASON
The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, WA and Canada
___________________________________
PRODUCT
RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. Recall # Z-0853-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by visit on July 21, 2009. Firm initiated recall is complete.
REASON
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland
___________________________________
PRODUCT
Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection and placement of a 0.014 (0.36 mm) Over the Wire (OTW) guide wire into peripheral vessels. The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intra-luminal cross-sectional ultrasound image of the area of interest to facilitate placement of guide wires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature. Recall # Z-0864-2011
CODE
All Lots, no serial numbers
RECALLING FIRM/MANUFACTURER
Medtronic CardioVascular, Santa Rosa, CA, by letter on April 30, 2010. Firm initiated recall is ongoing.
REASON
Needles may fail to retract and thus cause injury.
VOLUME OF PRODUCT IN COMMERCE
1,080 units
DISTRIBUTION
Nationwide, and Germany, Netherlands, Slovakia, and Spain
___________________________________
PRODUCT
Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300. The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access. Recall # Z-0865-2011
CODE
Lot numbers: REUF1011, REUF1303
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City, UT, by letter dated December 10, 2010.
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Tamaulipas, Mexico. Firm initiated recall is ongoing.
REASON
Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids. Recall # Z-0866-2011
CODE
Lot numbers: F762656, F762657, F775508, F775516, F775524, F775533, F775552, H101842, H101902, H108630, H110628, H110629, H110630, H110631, H113645, H113655, H115407, H115409, H118206 ,H118207, H118208, H118209, H118210, H118211, H121450, H121780, H124502, H124506, H124507, H124508, H124509, H124510, H124511, H134990, H134991, H134992, H134993, H134994, H137477, H139171, H141155, H141162, H144090, H144098, H152489, H161044, H168461, H176238, T119693, T121646, T122832,T124548, T130679, T132868, T132953, T133542, T134201, T135053, T137437, T139844, T140413, T140414, T141401, T141403, T141404, T142352, T143776, T146337, T146360, T149794, T150330, T150862, T151354, T153082, T153417, T153437, T153683, T153684, T153987, T154640, T157268, T160213, T162756, T167168, T167454, T167544, T168498, T171102, T171125, T171265, T173628, T173860, T174223, T176638, T176932, T177808, T178914, T179018, T179791, T181437
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter dated November 18, 2010. Firm initiated recall is ongoing.
REASON
The catheter's valve hub may fail resulting in an inability to drain fluid.
VOLUME OF PRODUCT IN COMMERCE
20,863 units
DISTRIBUTION
Nationwide, and countries of Canada, Finland, Germany, Netherlands, Singapore, Sweden, Switzerland, and the UK
___________________________________
PRODUCT
Stryker Digital Capture Pro 2 device, Product Code: LMD, LMB; Model Number: (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Recall # Z-0867-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letter dated December 11, 2009. Firm initiated recall is complete.
REASON
Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how pictures or videos are captured using SDC Pro 2 during surgery.
VOLUME OF PRODUCT IN COMMERCE
3,070 units
DISTRIBUTION
Nationwide, and the countries of Africa, Australia, Brazil, Cnanda, China, France, Germany, Hong Kong, Iberia, Italy, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Puerto Rico, Scandinavia, Singapore, Switzerland, Thailand, and the UK
___________________________________
PRODUCT
1) Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Material Number M00326010. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall #Z-0868-2011;
2) Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Material # M00326110. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0869-2011;
3) Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Material # M00326310. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0870-2011;
4) Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Material # M00326320. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0871-2011;
5) Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Material # M00326410. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0872-2011;
6) Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Material # M00326420. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0873-2011;
7) Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Material # M00326510. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0874-2011;
8) Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Material # M00326520. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0875-2011;
9) Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Material # M00313010. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0876-2011;
10) Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; Material # M00313020. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0877-2011;
11) Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Material # M00313310. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0878-2011;
12) Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip; Material # M00313320. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0879-2011;
13) Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Material # M00313410. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0880-2011;
14) Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip. Material # M00313510. The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures. Recall # Z-0881-2011
CODE
1) Lot/Best By date: B18002 10/31/2011 B18810 1/31/2012 B18112 10/31/2011 B18113 10/31/2011 B18114 10/31/2011 B18192 11/30/2011 B18193 11/30/2011 B18194 11/30/2011 B18195 11/30/2011 B18255 11/30/2011 B18256 11/30/2011 B18257 11/30/2011 B18258 11/30/2011 B18262 11/30/2011 B18263 11/30/2011 B18264 11/30/2011 B18265 11/30/2011 B18314 11/30/2011 B18434 12/31/2011 B18435 12/31/2011 B18436 12/31/2011 B18437 12/31/2011 B18438 12/31/2011 B18439 12/31/2011 B18471 12/31/2011 B18472 12/31/2011 B18473 12/31/2011 B18474 12/31/2011 B18475 12/31/2011 B18476 12/31/2011 B18477 12/31/2011 B18531 12/31/2011 B18532 12/31/2011 B18533 12/31/2011 B18700 12/31/2011 B18737 1/31/2012 B18738 1/31/2012 B18739 1/31/2012 B18775 1/31/2012 B18776 1/31/2012 B18806 1/31/2012 B18807 1/31/2012 B18808 1/31/2012 B18809 1/31/2012 B18810 1/31/2012 B18837 1/31/2012 B18838 1/31/2012 B18839 1/31/2012 B18840 1/31/2012 B18933 1/31/2012 B18985 3/31/2012 B18986 2/29/2012 B19052 2/29/2012 B19053 2/29/2012 B19119 2/29/2012 B19181 3/31/2012 B19186 3/31/2012 B19343 3/31/2012 B19344 3/31/2012 B17178 7/31/2011 B17179 7/31/2011 B17180 7/31/2011 B17181 7/31/2011 B17182 7/31/2011 B17183 7/31/2011 B17321 8/31/2011 B17322 8/31/2011 B17323 8/31/2011 B17324 8/31/2011 B17325 8/31/2011 B17326 8/31/2011 B17386 8/31/2011 B17387 8/31/2011 B17388 8/31 2011 B17389 8/31/2011 B17438 8/31/2011 B17439 8/31/2011 B17466 8/31/2011 B17467 8/31/2011 B17468 8/31/2011 B17505 8/31/2011 B17506 8/31/2011 B17599 9/30/2011 B17600 9/30/2011 B17601 9/30/2011 B17657 9/30/2011 B17658 9/30/2011 B17659 9/30/2011 B17660 9/30/2011 B17661 9/30/2011 B17662 9/30/2011 B`7663 9/30/2011 B17707 9/30/2011 B17708 9/30/2011 B17709 9/30/2011 B17710 9/30/2011 B17711 9/30/2011 B17712 9/30/2011 B17713 9/30/2011 B17820 10/31/2011 B17821 10/31/2011 B17822 10/31/2011 B17823 10/31/2011 B17824 10/31/2011 B17912 9/30/2011 B17923 10/31/2011 B17924 10/31/2011 B17925 10/31/2011 B17926 10/31/2011 B17927 10/31/2011 B17928 10/31/2011 B17929 10/31/2011 B17978 10/31/2011 B17979 10/31/2011 B17980 10/31/2011 B17981 10/31/2011 B17982 10/31/2011 B17983 10/31/2011 B18000 10/31/2011 B18001 10/31/2011 B17203 7/31/2011 B17204 7/31/2011 B17205 7/31/2011 B17206 7/31/2011 B17207 7/31/2011 B17276 7/31/2011 B17277 7/31/2011 B17278 7/31/2011 B17279 7/31/2011 B17280 7/31/2011 B17516 8/31/2011 B17517 8/31/2011 B17518 8/31/2011 B17519 8/31/2011 B17520 8/31/2011 B17588 8/31/2011 B17589 8/31/2011 B17590 8/31/2011 B17591 8/31/2011 B17592 9/30/2011 B17593 9/30/2011 B17812 9/30/2011 B17813 9/30/2011 B17814 9/30/2011 B17815 9/30/2011 B17816 9/30/2011 B17862 9/30/2011 B17863 9/30/2011 B17864 9/30/2011 B17865 9/30/2011 B17866 9/30/2011 B17867 9/30/2011 B18011 10/31/2011 B18012 10/31/2011 B18013 10/31/2011 B18014 10/31/2011 B18015 10/31/2011 B18016 10/31/2011 B18101 10/31/2011 B18102 10/31/2011 B18103 10/31/2011 B18104 10/31/2011 B18105 10/31/2011 B18330 11/30/2011;
2) Lot/use by dates: B17094 7/31/2011 B17095 7/31/2011 B17184 7/31/2011 B17332 8/31/2011;
3) Lot/use by dates: B17197 7/31/2011 B17911 9/30/2011 B18440 12/31/2011 B18478 12/31/2011 B18534 12/31/2011 B18741 1/31/2012;
4) Lot/use by dates: B17333 8/31/2011;
5) Lot/use by dates: B17096 7/31/2011 B17097 7/31/2011 B17098 7/31/2011 B17099 7/31/2011 B17185 7/31/2011 B17186 7/31/2011 B17187 7/31/2011 B17188 7/31/2011 B17198 7/31/2011 B17199 7/31/2011 B17287 7/31/2011 B17288 7/31/2011 B17327 8/31/2011 B17328 8/31/2011 B17329 8/31/2011 B17330 8/31/2011 B17331 8/31/2011 B17390 8/31/2011 B17391 8/31/2011 B17392 8/31/2011 B17393 8/31/2011 B17394 8/31/2011 B17469 8/31/2011 B17470 8/31/2011 B17472 8/31/2011 B17473 8/31/2011 B17474 8/31/2011 B17504 8/31/2011 B17507 8/31/2011 B17508 8/31/2011 B17509 8/31/2011 B17510 8/31/2011 B17602 9/30/2011 B17664 9/30/2011 B17665 9/30/2011 B17714 9/30/2011 B17715 9/30/2011 B17716 9/30/2011 B17717 9/30/2011 B17718 9/30/2011 B17719 9/30/2011 B17825 10/31/2011 B17826 10/31/2011 B817851 9/30/2011 B17931 10/31/2011 B17932 10/31/2011 B17933 10/31/2011 B17934 10/31/2011 B17984 10/31/2011 B17985 10/31/2011 B17986 10/31/2011 B17987 10/31/2011 B18003 10/31/2011 B18004 10/31/2011 B18082 10/31/2011 B18198 11/30/2011 B18200 11/30/2011 B18201 11/30/2011 B18202 11/30/2011 B18259 11/30/2011 B18260 11/30/2011 B18261 11/30/2011 B18266 11/30/2011 B18267 11/30/2011 B18268 11/30/2011 B18315 11/30/2011 B18316 11/30/2011 B18317 11/30/2011 B18318 11/30/2011 B18319 11/30/2011 B18394 12/31/2011 B18444 12/31/2011 B18445 12/31/2011 B18446 12/31/2011 B18447 12/31/2011 B18448 12/31/2011 B18449 12/31/2011 B18479 12/31/2011 B18480 12/31/2011 B18481 12/31/2011 B18484 12/31/2011 B18535 12/31/2011 B18536 12/31/2011 B18537 12/31/2011 B18538 12/31/2011 B18701 12/31/2011 B18742 1/31/2012 B18743 1/31/2012 B18812 1/31/2012 B18813 1/31/2012 B18814 1/31/2012 B18815 1/31/2012 B18816 1/31/2012 B18841 1/31/2012 B18842 1/31/2012 B18934 1/31/2012 B18987 2/29/2012 B18988 2/29/2012 B19023 2/29/2012 B19024 2/29/2012 B19110 2/29/2012 B19120 2/29/2012 B19187 3/31/2012 B19346 3/31/2012 B19379 3/31/2012 819384 3/31/2012;
6) Lot/use by dates: B17334 8/31/2011 B17603 9/30/2011 B17935 10/31/2011 B18203 11/30/2011 B18441 12/31/2011 B18744 1/31/2012 B18935 1/31/2012 B18945 2/29/2012 B19378 3/31/2012;
7) Lot/use by dates: B17289 7/31/2011 B17666 9/30/2011 B17720 9/30/2011 B17936 10/31/2011 B17990 10/31/2011 B18196 11/30/2011 B18197 11/30/2011 B18254 11/30/2011 B18442 12/31/2011 B18745 1/31/2012 B18811 1/31/2012 B18836 1/31/2012 B18946 2/29/2012 B19183 2/29/2012 B19307 3/31/2012;
8) Lot/use by dates: B17604 9/30/2011 B18443 12/31/2011 B18936 1/31/2012;
9) Lot/use by dates: B18331 11/30/2011 B18332 11/30/2011 B18333 11/30/2011 B18334 11/30/2011 B18335 11/30/2011 B18383 11/30/2011 B18384 11/30/2011 B18385 11/30/2011 B18386 11/30/2011 B18387 11/30/2011 B18388 11/30/2011 B18389 11/30/2011 B18544 12/31/2011 B18545 12/31/2011 B18546 12/31/2011 B18547 12/31/2011 B18548 12/31/2011 B18549 12/31/2011 B18650 12/31/2011 B18651 12/31/2011 B18652 12/31/2011 B18653 12/31/2011 B18654 12/31/2011 B18655 12/31/2011 B18656 12/31/2011 B18657 12/31/2011 B18843 1/31/2012 B18844 1/31/2012 B18845 1/31/2012 B18887 1/31/2012 B18888 1/31/2012 B18889 1/31/2012 B18890 1/31/2012 B18891 1/31/2012 B18897 1/31/2012 B18898 1/31/2012 B18899 1/31/2012 B18900 1/31/2012 B18901 1/31/2012 B18902 1/31/2012 B19094 2/29/2012 B19095 2/29/2012 B19106 2/29/2012 B19107 2/29/2012 B19108 2/29/2012 B19233 3/31/2012 B19235 3/31/2012 B19240 3/31/2012 B19298 3/31/2012 B19299 3/31/2012 B19389 3/31/2012 B19390 4/30/2012 B19454 4/30/2012 B19466 4/30/2012;
10) Lot/use by dates: B17208 7/31/2011 B17522 8/31/2011 B17594 9/30/2011 B17817 9/30/2011 B17853 9/30/2011 B18017 10/31/2011 B18107 10/31/2011 B18390 11/30/2011 B18550 12/31/2011 B18886 1/31/2012 B19069 2/29/2012;
11) Lot/use by dates: B17281 7/31/2011 B17595 9/30/2011 B18018 10/31/2011 B18336 11/30/2011 B18885 1/31/2012 B19068 2/29/2012 B19236 3/31/2012;
12) Lot/use by dates: B17854 9/30/2011 B19301 3/31/2012;
13) Lot/use by dates: B17209 7/31/2011 B19510 4/30/2012;
14) Lot/use by dates: B17282 7/31/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Fremont, CA, by letter dated June 7, 2010.
Manufacturer: Boston Scientific Corp., West Valley City, UT. Firm initiated recall is ongoing.
REASON
The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.
VOLUME OF PRODUCT IN COMMERCE
36,049 units
DISTRIBUTION
CA, CO, IN, MD, MI, OR, TX, VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine
___________________________________
PRODUCT
1) Air bubble detect module, catalog 802110. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit. Recall # Z-0882-2011;
2) Occluder module, catalog 803480. The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. Recall # Z-0883-2011
CODE
1) Units: 01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01563, 01565-01581, 01583-01609, 01611, 01613-01660, 01662-01721, 01724-01725;
2) Units: 00632-00635, 00638, 00642-00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated December 2, 2010. Firm initiated recall is ongoing.
REASON
A component within the System 1 ABD and Occluder Modules may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. The firm identified a failure mode on both the ABD and Occluder modules where the modules may become non-functional. The user is notified of a problem, but may not be fully aware of what the problem is
VOLUME OF PRODUCT IN COMMERCE
729 units
DISTRIBUTION
Nationwide and Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatemala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
___________________________________
PRODUCT
CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions. Recall # Z-0884-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter dated October 5, 2010. Firm initiated recall is ongoing.
REASON
When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
VOLUME OF PRODUCT IN COMMERCE
1,692 units
DISTRIBUTION
Nationwide and Belgium, China, Israel, Japan, Singapore, and Thailand
___________________________________
PRODUCT
Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery. Recall # Z-0886-2011
CODE
Codes: H294145 H293620 H271973 H272328 H293393 H294467 H293944 H293764 H293725 H140117 H140734 H272492 H140070 H293653 H293998 H294049 H294199 H293726 H271877 H293666 H273065 H272283 H293823 H293999 H293697 H294367 H293728 H272434 H140754 H273130 H272370 H293529 H290201 H294103 H294440 H293698 H272828 H293724 H273170 H272327 H293787 H290555 H293760 H294474 H293774 H272889 H293817 H293381 H272329 H140772 H290553 H293682 H294496 H293776 H272922 H140768 H140709 H272299 H293883 H290549 H293009 H294597 H293773 H140203 H140775 H293411 H272425 H294113 H290552 H293942 H294641 H293829 H140204 H293843 H293412 H272421 H294129 H290551 H293765 H294650 H293830 H291054 H293847 H293463 H272407 H293908 H290559 H293758 H294699 H293854 H273072 H140786 H140729 H272857 H293909 H293396 H290557 H291075 H293839 H140208 H293850 H293499 H272859 H294134 H290547 H293770 H293368 H294073 H291098 H293968 H293500 H291022 H294186 H290541 H294136 H140756 H294118 H291114 H294022 H293668 H291011 H294092 H293365 H294143 H294034 H294104 H273027 H293970 H293841 H291015 H294273 H293435 H294239 H294527 H294200 H273107 H294017 H294164 H291082 H294204 H293387 H294185 H294107 H294203 H273102 H140796 H140882 H291021 H294210 H293482 H294248 H294535 H294256 H291160 H294065 H293567 H291016 H294317 H290554 H294290 H273048 H140856 H291191 H294062 H290278 H291085 H140836 H293434 H294390 H273140 H294471 H291164 H294175 H273187 H291018 H294364 H293555 H293766 H293371 H273150 H291165 H294232 H293595 H291154 H294403 H293506 H294153 H273208 H293898 H291163 H140819 H140763, H291166 H294383 H293569 H293961 H293305 H271763 H273103 H294409 H293929 H291190 H294414 H273031 H294250 H293681 H273117 H140229 H140843 H293958 H291172 H293906 H293853 H294422 H293842 H273182 H140234 H294448 H293450 H291231 H294347 H293455 HCX4138 H293924 H293374 H140231 H140844 H271159 H291179 H294585 H293498 H294011 H294462 H293601 H291212 H294584 H271157 H291178 H294586 H293633 H294445 H294525 H293602 H140236 H140865 H271569 H293307 H294553 H293477 H294480 H294532 H293645 H140235 H294667 H271624 H291195 H294551 H293489 H294400 H294608 H293661 H291261 H272188 H271662 H291194 H294674 H293626 HCX4400 H140096 H294098 H140232 H272946 H271663 H291180 H294683 H293705 H294490 H140097 H294123 H291262 H293494 H271941 H293509 H294684 H293676 H294488 H291115 H294296 H293422 H294593 H271926 H293598 H294675 H293710 H294449 H293424 H294297 H293442 H294594 H272157 H293549 H294352 H293907 H294568 H293444 H294304 H140713 H293796 H272216 H140728 H294750 H293586 H294634 H140751 H294543 H291259 H293940 H272159 H293521 H294751 H293745 H294611 H293662 H294461 H291260 H294526 H272162 H293656 H294758 H293838 H294015 H293663 H294592 H293512 H294502 H272311 H293654 H294766 H293978 H293495 H293650 H270794 H140732 H293324 H272309 H293655 H293336 H293738 H293759 H293727 H271582 H293561 H273186 H272310 H293784 H293337 H293753 H293761 H293612 H272277 H272372 H293407 H294201 H273164 H294146 H294140 H294602 H294428 H293363 H272473 H293474 H294109 H273162 H294114 H294133 H294636 H294460 H293362 H272458 H140711 H294228 H273191 H294368 H140124 H273185 H140857 H293380 H272494 H140704 H140822 H273200 H294356 H290533 H273036 H294432 H293410 H273011 H140717 H294241 H273203 H294346 H294329 H273168 H294587 H293440 H140119 H293578 H294230 H293321 H294264 H294433 H291199 H294647 H293408 H140114 H140154 H294262 H273202 H294233 H292832 H291268 H294183 H293452 H273077 H293533 H294242 H293379 H294357 H272834 H140715 H294371 H293430 H273080 H140707 H294280 H293388 H140842 H291174 H293502 H290282 H140719 H273106 H140742 H140850 H293378 H294084 H273172 H294074 H273064 H293409 H273110 H140731 H294057 H293376 H294231 H290556 H293353 H140129 H293454 H273121 H293576 H294529 H293392 H294274 H273066 H293947 H273089 H293312 H273126 H293625 H294419 H273210 H294415 H293333 H294042 H273039 H293449 H273131 H140740 H294519 H293464 H294160 H293304 H294043 H273042 H293451 H273104 H293644 H140863 H293389 H294477 H273178 H271802 H273092 H293527 H273128 H293675 H294581 H293597 H294310 H293524 H272195 H273134 H293523 H273147 H140759 H294627 H293640 H294536 H293665 H272985 H273127 H293566 H273160 H140748 H294605 H293686 H294601 H293844 H140125 H273122 H293557 H140140 H293624 H140872 H293619 H294591 H293897 H272932 H290548 H293558 H140142 H293651 H294646 H140747 H294545 H293755 H273113 H273111 H293623 H273177 H272905 H140875 H140758 H294511 H140774 H273083 H273116 H293641 H273167 H293779 H294678 H293530 H294369 H293946 H273115 H273119 H293634 H273175 H293646 H140871 H293735 H294547 H293793 H273145 H273144 H293719 H273171 H140764 H140887 H293763 H294548 H294121 H272964 H273132 H293720 H273165 H293861 H294068 H293736 H294473 H293876 H293370 H273133 H293721 H273204 H140766 H294067 H140760 H294589 H294124 H272973 H140138 H293730 H140144 H140779 H293534 H293845 H140866 H293677 H273183 H273124 H293729 H140148 H293860 H271370 H293732 H294645 H293310 H140724 H273156 H293762 H140146 H140788 H271378 H293465 H294671 H294351 H140712 H140137 H293788 H140145 H293918 H271531 H293955 H294685 H294387 H293419 H140141 H293797 H140151 H293922 H271593 H293982 H294724 H294212 H293443 H273123 H293792 H140150 H293949 H272137 H293575 H293643 H294374 H293491 H273125 H293799 H293351 H293954 H272111 H294036 H293857 H294465 H140762 H273163 H140767 H293373 H293963 H272497 H293917 H294198 H294618 H293781 H273194 H293813 H140139 H140794 H272875 H293791 H273166 H294423 H140769 H291257 H293800 H140153 H293992 H272909 H294085 H140862 H294060 H294100 H273197 H293809 H140708 H294023 H273101 H294167 H294292 H294542 H294161 H273138 H293832 H293391 H140798 H140136 H294119 H290561 H294515 H294223 H273193 H293798 H293334 H294173 H273151 H294005 H140152 H294664 H140789 H273189 H293807 H293369 H140815 H273174 H294117 H293585 H294238 H140841 H140238 H293816 H293815 H294342 H293808 H140839 H291083 H273082 H273180 H294215 H294349 H293814 H294334 H294656 H294335 H291127 H293306 H293320 H294229 H294588 H140773 H140828 H294659 H140739 H291128 H273181 H294144 H294315 H294705 H293827 H140834 H140873 H291064 H291141 H293375 H294205 H294370 H293618 H293828 H294318 H294610 H291227 H291168 H293532 H294401 H294569 H271265 H293881 H294309 H140889 H291044 H291204 H294080 H294402 H272033 H272219 H293895 H294293 H294600 H291132 H291205 H294435 H294495 H273084 H290386 H293896 H294307 H294693 H293540 H291223 H294434 H140886 H273108 H272405 H293920 H294338 H294723 H140755 H293447 H294746 H291130 H140147 H272362 H293911 H294363 H140892 H293959 H271860 H271881 H291137 H273179 H272333 H293943 H294283 H294635 H293678 H271976 H272023 H291055 H273201 H291037 H293887 H294396 H294643 H293997 H271681 H293349 H140135 H273198 H291238 H293812 H294308 H294666 H293616 H140847 H293545 H291198 H291254 H291237 H140785 H294450 H294668 H294097 H291250 H293801 H273159 H273184 H293395 H293884 H294447 H294676 H294247 H293469 H140840 H273153 H273195 H293448 H294002 H140849 H294700 H294313 H293468 H140874 H293421 H293479 H293394 H294027 H294319 H294701 H290208 H294344 H140700 H293456 H293572 H293423 H294046 H294451 H294706 H290274 HCX4344 H294044 H293364 H293559 H293604 H294152 H294312 H294713 H290400 H140090 H140878 H293704 H293570 H293657 H140804 H294407 H294715 H290399 H140101 H140803 H293553 H293390 H293767 H294071 H294260 H294726 H272359 H290517 H273112 H293631 H293599 H290372 H140814 H294066 H294728 H290501 H140121 H273176 H293628 H293446 H294037 H294154 H294463 H294731 H291211 H140062 H294108 H293679 H293382 H294082 H294195 H294503 H294732 H293596 H140143 H294190 H293794 H293383 H140790 H294220 H294087 H294736 H293741 H293384 H294191 H293386 H140730 H294219 H294176 H294213 H294737 H293866 H140705 H294520 H293471 H293712 H294681 H294165 H294580 H293603 H293964 H293328 H294606 H293629 H293497 H294682 H294258 H294583 H294093 H294331 H140134 H290256 H293785 H293849 H271400 H294271 H294492 H294491 H140877 H293637 H271890 H293786 H293852 H272397 H294270 H294582 H294279 H272418 H140745 H273173 H293870 H293951 H272427 H294276 H294508 H294533 H291009 H140750 H273155 H294038 H293941 H290511 H294277 H294590 H293550 H291103 H140741 H293372 H293904 H293972 H272911 H294278 H294632 H293938 H293531 H140749 H293977 H293905 H294193 H291033 H294289 H294339 H294489 H140752 H294070 H294055 H293510 H294192 H290540 H294216 H294094 H290262 H293574 H294072 H140743 H293869 H294208 H291213 H294217 H294637 H290263 H293996 H140805 H140771 H294047 H294211 H291232 H294281 H294537 H290352 H294081 H294069 H294214 H294059 H294389 H293577 H294272 H294649 H291046 H294523 H140859 H294779 H140818 H294014 H293593 H294306 H294619 H293630 H290423 H140861 H294565 H293878 H293990 H293492 H294288 H294663 H140823 H291007 H291059 H273142 H294147 H293991 H293649 H293667 H293511 H272908 H294102 H290249 H140001 H272014 H140046 H272401 H293742 H293339 H273004 H294076 H271393 H271760 H290362 H272238 H272394 H293652 H290560 H273049 H294077 H271407 H271762 H272009 H272237 H272801 H293818 H294639 H272469 H294078 H271413 H271785 H271975 H272236 H272456 H293834 H294640 H273063 H294079 H271385 H271780 H271964 H272259 H272470 H293778 H291233 H273105 H294218 H271439 H271797 H272052 H290392 H272500 H293914 H293879 H291152 H293867 H271452 H271835 H272000 H272271 H272803 H293928 H273149 H291151 H294257 H271438 H271838 H272043 H140058 H272454 H293965 H273152 H140224 H294354 H271425 H271831 H272035 H272301 H272466 H293981 H293323 H140225 H294263 H271502 H271783 H140038 H272306 H272479 H293993 H273114 H140226 H294323 H271515 H271858 H272045 H290397 H272491 H140797 H293315 H140227 H294321 H271519 H271856 H271951 H272307 H140088 H294305 H293584 H291271 H294320 H271526 H271862 H272049 H272291 H272480 H140864 H293739 H273206 H294322 H271507 H271833 H290376 H272321 H140092 H273143 H293803 H293325 H294268 H271523 H140011 H271942 H272325 H140201 H271994 H293687 H293326 H294539 H290287 H271879 H272062 H272293 H290505 H291008 H293795 H293207 H294541 H271497 H271825 H272069 H272326 H272816 H291182 H293865 H293356 H294171 H271559 H271870 H272001 H272302 H290503 H291108 H294110 H293327 H294540 H271587 H271893 H272086 H272346 H272476 H293311 H294111 H293416 H294538 H271588 H271896 H272078 H290405 H272811 H293331 H294040 H293417 H294621 H271420 H271900 H272089 H272345 H290509 H293556 H293301 H293377 H294620 H271594 H290341 H140043 H140073 H272837 H293507 H293314 H273055 H294716 H271607 H271903 H290371 H290402 H272822 H293747 H294345 H293441 H140893 H271626 H140018 H272081 H140071 H272824 H140795 H294412 H293583 H270788 H271669 H271921 H272129 H272336 H272488 H293740 H294411 H293674 H271041 H271664 H290326 H272134 H140067 H272854 H293980 H294379 H293671 H270862 H290304 H271906 H140045 H272354 H272860 H293872 H294438 H293672 H271066 H271691 H271918 H272143 H272365 H140098 H293875 H294439 H293670 H271105 H290313 H271895 H272172 H272341 H272841 H293960 H294388 H293716 H271169 H290308 H271935 H272187 H272355 H272862 H140829 H294644 H293715 H290241 H271678 H271966 H272178 H272377 H290510 H291272 H273056 H293717 H271167 H271618 H140026 H290379 H140076 H272873 H293496 H293752 H293718 H271242 H140020 H140027 H272202 H272388 H290508 H293600 H294255 H293669 H290222 H271711 H140031 H272174 H272410 H272866 H293638 H293751 H293804 H271362 H271693 H271993 H272209 H272422 H272868 H293848 H273148 H293820 H271194 H271712 H271961 H272220 H272428 H272872 H294141 H294657 H293782 H271308 H271720 H271974 H272204 H140078 H272847 H294265 H271954 H293826 H290224 H271729 H140025 H140047 H140077 H272885 H294284 H271872 H293713 H271334 H271714 H272029 H272231 H272426 H272914 H290550,H272826 H293714 H290243 H271724 H272003 H272223 H272444 H291002 H290600 H273029 H291076 H291048 H273135 H291219 H293303 H293318 H293432 H272893 H291028 H291077 H291088 H291140 H140233 H291236 H293357 H293425 H290520 H273030 H291052 H140211 H291045 H291202 H293332 H291229 H293300 H291006 H291032 H291079 H291099 H291109 H291169 H291266 H291249 H293438 H140109 H272971 H272978 H140215 H291117 H291200 H291247 H140149 H140706 H272899 H291027 H291073 H140133 H291111 H291218 H291256 H293313 H293366 H291001 H291025 H291067 H291120 H291116 H291170 H291270 H291252 H293404 H291004 H291026 H291078 H291136 H291157 H291196 H291253 H140703 H293348 H272926 H291038 H291063 H140219 H291161 H291221 H293316 H293345 H293486 H272938 H273016 H140216 H273120 H291113 H291222 H140240 H293429 H293397 H290519 H272982 H140213 H273109 H140220 H291207 H293308 H293431 H293490 H291003 H291023 H291090 H291149 H291092 H291209 H293322 H293385 H293503 H140111 H272990 H291068 H291134 H273137 H140228 H291224 H293426 H291176 H140202 H291029 H291074 H291096 H273136 H291133 H291243 H293342 H293439 H272960 H291020 H140217 H291139 H291162 H291181 H291225 H293360 H293508 H272981 H291042 H273026 H273118 H291183 H291171 H291267 H293418 H293485 H272842 H272825 H291072 H291142 H291150 H291185 H291245 H293428 H293518 H291013 H291035 H291080 H291094 H291131 H291216 H291258 H293414 H293406 H291005 H291039 H291097 H140218 H291053 H291203 H291255 H291226 H293354 H140205 H291043 H291093 H140221 H140223 H291210 H290558 H291248 H293459 H291010 H272987 H291100 H291101 H273158 H273199 H293343 H291263 H293476 H272846 H140207 H291105 H291146 H291159 H291208 H293358 H293436 H140720 H272848 H291041 H291066 H140222 H291135 H291234 H293329 H293403 H293466 H290504 H291049 H291069 H140209 H291186 H291235 H293340 H293460 H293483 H290512 H273052 H291081 H291119 H291192 H291215 H293335 H293413 H293405 H272956 H273040 H291061 H291123 H291184 H291220 H293350 H140239 H293488 H272963 H291050 H273075 H291129 H291187 H291206 H293309 H293402 H293420 H272993 H291056 H140214 H291121 H291144 H291241 H293346 H293472 H293433 H272999 H291065 H140206 H291122 H291143 H140237 H291230 H293398 H293484 H291024 H140212 H291106 H291112 H291167 H291175 H293352 H140714 H140722 H291012 H291057 H291102 H291145 H291158 H291217 H293302 H293453 H293401 H272986 H291058 H291084 H273141 H291177 H291264 H291240 H293445 H293541 H291019 H291070 H291086 H291153 H273157 H273190 H293361 H293437 H293548 H140115 H291071 H291087 H291118 H291148 H273209 H291269 H293427 H293344 H291017 H273053 H291089 H291155 H291188 H291242 H291251 H293457 H293480 H291014 H291047 H291107 H291125 H291197 H291173 H293317 H140716 H293481 H291030 H291051 H272996 H291126 H140230 H291246 H293330 H293461 H293478 H291034 H291062 H291104 H291138 H291189 H291214 H291239 H293462 H293536 H290530 H291031 H291040 H291147 H291193 H291273 H291265 H293355 H293581 H291036 H291060 H140210 H291156 H291124 H291228 H293399 H293415 H293319 H293501 H293591 H293673 H293695 H293873 H293919 H294032 H140806 H294184 H293517 H293562 H293690 H140733 H293891 H140791 H294045 H294105 H294166 H293519 H293504 H293587 H293771 H293890 H293926 H294030 H294112 H294178 H293473 H293590 H293689 H293756 H293880 H293932 H294006 H294053 H294209 H293458 H293592 H293706 H140736 H293855 H293925 H294033 H293986 H140813 H293367 H293538 H293647 H293611 H293868 H293948 H294041 H294125 H294194 H293568 H293608 H293700 H293783 H140780 H293956 H294051 H140807 H294234 H293564 H293539 H293696 H293790 H293877 H293930 H294026 H140808 H294227 H293579 H140701 H293694 H293750 H293885 H140793 H294048 H140810 H294207 H293475 H293610 H293554 H293806 H293864 H293962 H294039 H294130 H294116 H291095 H140746 H293702 H140765 H293882 H293966 H293974 H294095 H294101 H293359 H140718 H293692 H293708 H140784 H293899 H293994 H294106 H294197 H293544 H140735 H293693 H293658 H293701 H293967 H294004 H294122 H294181 H293552 H293522 H293699 H293769 H293862 H293936 H294031 H294142 H294196 H293565 H293543 H293703 H293821 H293913 H293953 H294008 H294132 H294188 H293589 H293594 H293746 H293819 H140770 H293971 H294063 H294157 H294237 H293347 H293505 H291201 H293824 H293888 H293957 H294003 H294151 H294131 H293487 H293642 H293733 H140776 H293902 H293934 H293984 H294099 H294202 H293514 H293648 H140757 H293789 H293900 H293950 H294024 H294054 H294225 H293516 H293588 H293709 H293825 H140783 H293969 H294028 H294135 H294029 H293467 H293606 H293734 H293754 H293886 H293995 H294025 H140809 H294148 H293513 H293537 H293685 H293802 H293910 H293975 H294061 H294137 H294162 H293515 H293520 H293535 H293573 H293912 H293987 H294052 H140811 H294163 H293546 H293551 H293659 H293805 H293889 H140782 H294050 H294156 H294240 H293614 H293621 H293707 H293836 H293874 H293952 H294056 H294159 H294243 H140725 H293622 H293743 H293822 H293893 H293988 H293983 H294168 H140821 H293525 H293660 H293723 H293846 H293903 H293985 H294086 H294058 H294244 H293617 H293639 H291244 H140778 H293915 H293921 H140799 H294179 H294252 H140721 H140738 H293744 H140777 H293935 H294009 H294088 H140801 H294149 H140726 H293636 H293748 H293856 H140787 H293979 H294075 H294169 H294126 H140727 H293607 H140753 H293831 H293772 H294010 H294064 H294172 H294127 H273196 H293571 H140761 H293851 H293931 H294021 H294000 H294155 H294128 H293615 H293683 H293737 H293840 H293894 H293989 H294089 H294177 H294245 H140723 H293563 H293341 H293859 H293923 H293976 H294091 H294187 H294254 H293609 H140710 H140737 H293835 H293901 H294016 H294120 H140800 H294269 H293560 H293684 H293749 H293863 H293892 H294012 H140802 H140817 H140820 H293470 H293493 H293688 H293664 H140781 H294018 H294007 H294182 H294267 H293635 H293613 H293780 H293858 H293916 H294013 H294083 H294170 H294226 H293627 H293691 H293775 H293837 H293933 H294001 H294035 H294189 H294266 H140744 H293605 H293777 H293871 H140792 H294020 H294090 H294180 H294285 H294261 H294360 H294397 H294521 H294572 H140883 H294282 H294394 H293833 H140825 H294158 H294421 H294443 H294577 H294698 H294425 H294406 H294507 H294679 H294324 H294381 H294430 H294235 H294358 H294429 H294530 H294571 H294696 H294325 H294380 H294479 H140824 H140838 H140848 H294534 H294574 H294711 H140831 H294395 H294494 H140827 H294246 H294436 H294517 H294236 H294720 H294336 H294399 H294418 H294287 H294333 H294437 H294470 H294598 H294719 H140832 H294362 H294478 H294286 H294355 H294424 H294510 H140855 H294712 H294332 H294372 H294482 H294295 H294361 H294426 H294513 H294603 H294677 H294348 H294398 H294504 H294224 H294373 H294469 H294516 H294604 H294686 H294350 H294420 H294485 H294299 H294340 H140851 H294524 H294616 H140897 H294353 H294408 H294481 H294298 H294392 H294444 H294441 H140816 H294738 H294341 H294385 H294499 H294301 H294376 H294468 H294544 H294599 H294735 H140833 H140846 H294483 H294316 H294174 H140852 H294528 H294595 H294729 H294337 H294413 H294514 H294302 H294377 H294359 H294518 H294612 H294742 H294343 H294442 H140854 H140812 H140830 H294472 H294206 H294629 H294727 H294330 H294404 H294484 H294303 H294378 H140826 H294546 H294625 H140891 H140835 H294410 H294505 H294314 H294384 H294416 H140845 H140867 H294743 H140837 H294417 H294501 H294476 H294615 H140881 H294493 H140868 H294747 H294221 H294386 H140853 H294554 H294576 H140895 H294531 H294555 H294753 H294327 H294382 H294497 H294556 H294630 H140896 H294487 H140869 H294689 H294498 H294617 H294690 H294552 H294613 H294730 H294300 H294624 H294761 H294500 H294642 H294763 H294506 H294653 H294771 H294431 H294652 H294783 H294391 H294567 H140702 H294549 H294658 H294773 H294311 H294654 H294794 H294573 H294694 H294253 H294575 H294680 H294782 H294446 H294665 H291091 H140858 H294626 HCX4019 H294550 H294695 H294291 H140876 H293542
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on May 27, 2010, and web site posting. Firm initiated recall is ongoing.
REASON
The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.
VOLUME OF PRODUCT IN COMMERCE
2,399 units
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK
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PRODUCT
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01. The Zimmer Title 2 counter torque assembly tool is a re-useable, non- implantable surgical tool that is provided as part of the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening. Recall # Z-0887-2011
CODE
Lot: L75118
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated October 21, 2010.
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. Firm initiated recall is ongoing.
REASON
There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. There could be a delay in surgery to remove the ball plunger. If the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal.
VOLUME OF PRODUCT IN COMMERCE
68 units
DISTRIBUTION
Nationwide
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PRODUCT
Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C). Recall # Z-0888-2011
CODE
Units: HZ5071, HZ59014 and HZ59017
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, letter on January 26, 2009. Firm initiated recall is ongoing
REASON
Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, WI
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PRODUCT
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site. Part number 5140-6221. Recall # Z-0889-2011
CODE
Lot numbers: 2010060684 & 2010071887
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Assist, Inc., Pittsburgh, PA, by letter dated November 12, 2010.
Manufacturer: Atek Medical Manufacturing, Grand Rapids, MI. Firm initiated recall is ongoing.
REASON
Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications.
VOLUME OF PRODUCT IN COMMERCE
164 devices
DISTRIBUTION
Nationwide
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PRODUCT
4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall # Z-0891-2011
CODE
Units: H510001 H51009 H510129 H510202 H510286 H510350 H510410 H510468 H510514 H510002 H510050 H510130 H510206 H510289 H510351 H510411 H510470 H510515 H510003 H510067 H510131 H510207 H510290 H510352 H510417 H510471 H510516 H510004 H510068 H510135 H510211 H510291 H510353 H510419 H510472 H510517 H510005 H510069 H510136 H510215 H510292 H510364 H510425 H510473 H510519 H510007 H510070 H510137 H510220 H510293 H510368 H510426 H510474 H510520 H510008 H510071 H510146 H510222 H510300 H510370 H510427 H510476 H510521 H510009 H510072 H510150 H510225 H510301 H510371 H510428 H510477 H510522 H510010 H510074 H510151 H510226 H510302 H510372 H510429 H510479 H510523 H510012 H510075 H510160 H510231 H510303 H510373 H510430 H510480 H510525 H510014 H510077 H510162 H510233 H510304 H510375 H510431 H510481 H510526 H510015 H510081 H510163 H510234 H510306 H510376 H510432 H510482 H510528 H510016 H510083 H510165 H510236 H510307 H510377 H510433 H510483 H510529 H510017 H510084 H510171 H510241 H510309 H510378 H510434 H510484 H510530 H510018 H510088 H510172 H510262 H510310 H510379 H510435 H510488 H510531 H510019 H510089 H510173 H510263 H510316 H510380 H510436 H510489 H510532 H510021 H510090 H510174 H510264 H510317 H510381 H510437 H510490 H510533 H510022 H510091 H510175 H510265 H510318 H510382 H510441 H510491 H510534 H510025 H510092 H510176 H510267 H510319 H510383 H510442 H510492 H510535 H510027 H510093 H510180 H510268 H510320 H510384 H510443 H510493 H510536 H510029 H510094 H510181 H510269 H510321 H510385 H510445 H510494 H510537 H510030 H510095 H510183 H510270 H510322 H510386 H510446 H510495 H510538 H510031 H510096 H510184 H510271 H510330 H510388 H510447 H510496 H510539 H510032 H510097 H510185 H510272 H510332 H510389 H510448 H510498 H510540 H510033 H510098 H510188 H510273 H510335 H510391 H510449 H510499 H510541 H510035 H510099 H510189 H510275 H510337 H510392 H510450 H510500 H510542 H510036 H510104 H510190 H510276 H510338 H510394 H510451 H510501 H510543 H510039 H510106 H510191 H510277 H510339 H510396 H510456 H510503 H510544 H510040 H510107 H510192 H510278 H510340 H510397 H510457 H510505 H510549 H510041 H510113 H510194 H510279 H510341 H510398 H510459 H510506 H510550 H510042 H510114 H510195 H510280 H510342 H510399 H510460 H510507 H510551 H510043 H510115 H510196 H510281 H510343 H510401 H510461 H510510 H510552 H510044 H510125 H510197 H510282 H510344 H510402 H510464 H510511 H510553 H510045 H510126 H510199 H510283 H510345 H510408 H510465 H510512 H510554 H510046 H510127 H510201 H510285 H510346 H510409 H510467 H510513 H510555 H510556 H510613 H510665 H510731 H510786 H510844 H510912 H510959 H511014 H510560 H510614 H510668 H510732 H510788 H510845 H510913 H510964 H511015 H510564 H510616 H510669 H510733 H510789 H510846 H510914 H510966 H511016 H510565 H510617 H510670 H510735 H510791 H510847 H510915 H510967 H511018 H510567 H510618 H510672 H510736 H510793 H510848 H510916 H510968 H511021 H510568 H510619 H510673 H510738 H510794 H510849 H510917 H510970 H511022 H510569 H510620 H510676 H510739 H510795 H510850 H510918 H510971 H511023 H510570 H510621 H510677 H510740 H510797 H510852 H510920 H510972 H511024 H510571 H510622 H510678 H510741 H510798 H510853 H510921 H510974 H511025 H510574 H510623 H510679 H510742 H510799 H510854 H510922 H510976 H511026 H510575 H510624 H510680 H510743 H510800 H510855 H510923 H510977 H511028 H510577 H510625 H510681 H510744 H510801 H510856 H510924 H510978 H511029 H510578 H510628 H510682 H510745 H510802 H510860 H510925 H510979 H511030 H510579 H510631 H510683 H510746 H510804 H510862 H510926 H510980 H511031 H510580 H510632 H510684 H510748 H510805 H510863 H510927 H510981 H511032 H510581 H510634 H510686 H510749 H510806 H510864 H510930 H510982 H511033 H510582 H510635 H510688 H510750 H510807 H510865 H510931 H510983 H511034 H510584 H510636 H510689 H510751 H510808 H510866 H510932 H510984 H511035 H510586 H510637 H510690 H510754 H510809 H510867 H510933 H510987 H511036 H510587 H510638 H510691 H510756 H510811 H510868 H510934 H510989 H511039 H510588 H510639 H510693 H510758 H510814 H510885 H510935 H510990 H511040 H510589 H510640 H510694 H510759 H510816 H510886 H510936 H510991 H511042 H510590 H510641 H510695 H510760 H510819 H510887 H510937 H510992 H511043 H510591 H510646 H510699 H510761 H510820 H510888 H510938 H510994 H511044 H510592 H510647 H510701 H510763 H510822 H510889 H510941 H510995 H511045 H510594 H510648 H510702 H510769 H510823 H510891 H510942 H510996 H511046 H510595 H510649 H510705 H510770 H510825 H510892 H510943 H510997 H511047 H510596 H510650 H510706 H510773 H510827 H510894 H510944 H510998 H511049 H510598 H510651 H510707 H510774 H510828 H510896 H510945 H510999 H511050 H510599 H510652 H510708 H510775 H510830 H510897 H510946 H511000 H511051 H510600 H510653 H510709 H510776 H510833 H510898 H510947 H511001 H511052 H510602 H510654 H510710 H510777 H510834 H510901 H510948 H511002 H511053 H510603 H510655 H510712 H510778 H510835 H510903 H510949 H511003 H511054 H510604 H510656 H510713 H510779 H510837 H510905 H510950 H511004 H511055 H510605 H510657 H510714 H510780 H510838 H510906 H510951 H511006 H511056 H510607 H510658 H510716 H510781 H510839 H510907 H510952 H511008 H511057 H510608 H510659 H510717 H510782 H510840 H510908 H510953 H511009 H511058 H510609 H510662 H510718 H510783 H510841 H510909 H510954 H511010 H511060 H510610 H510663 H510722 H510784 H510842 H510910 H510955 H511012 H511061 H510612 H510664 H510730 H510785 H510843 H510911 H510957 H511013 H511062 H511063 H511114 H511166 H511219 H511267 H511328 H511379 H511434 H511480 H511064 H511116 H511167 H511221 H511268 H511329 H511382 H511436 H511482 H511066 H511117 H511168 H511222 H511269 H511330 H511385 H511437 H511483 H511069 H511119 H511169 H511223 H511270 H511331 H511386 H511439 H511484 H511070 H511120 H511170 H511224 H511273 H511332 H511389 H511440 H511485 H511071 H511122 H511174 H511225 H511274 H511333 H511390 H511441 H511486 H511072 H511123 H511175 H511227 H511275 H511334 H511391 H511442 H511487 H511073 H511125 H511176 H511229 H511276 H511335 H511392 H511443 H511488 H511074 H511126 H511178 H511230 H511279 H511336 H511393 H511446 H511489 H511075 H511128 H511179 H511231 H511281 H511337 H511394 H511447 H511490 H511077 H511129 H511183 H511232 H511282 H511339 H511398 H511448 H511491 H511078 H511130 H511184 H511233 H511284 H511340 H511399 H511449 H511492 H511080 H511131 H511185 H511234 H511285 H511341 H511400 H511451 H511493 H511081 H511132 H511186 H511235 H511286 H511342 H511401 H511452 H511494 H511082 H511134 H511187 H511236 H511287 H511343 H511402 H511453 H511496 H511083 H511135 H511188 H511237 H511288 H511344 H511403 H511455 H511497 H511084 H511137 H511189 H511238 H511289 H511346 H511404 H511456 H511498 H511085 H511138 H511190 H511239 H511290 H511347 H511405 H511457 H511500 H511086 H511139 H511191 H511240 H511291 H511348 H511406 H511458 H511501 H511090 H511140 H511192 H511241 H511292 H511349 H511408 H511459 H511503 H511091 H511142 H511193 H511242 H511293 H511350 H511409 H511460 H511504 H511092 H511143 H511195 H511243 H511294 H511351 H511411 H511461 H511505 H511093 H511144 H511196 H511245 H511295 H511352 H511412 H511462 H511506 H511094 H511145 H511197 H511246 H511296 H511353 H511414 H511463 H511507 H511095 H511146 H511199 H511247 H511300 H511354 H511415 H511464 H511508 H511096 H511147 H511200 H511248 H511302 H511358 H511416 H511465 H511509 H511098 H511149 H511202 H511249 H511303 H511359 H511417 H511466 H511510 H511099 H511150 H511203 H511250 H511305 H511360 H511418 H511467 H511511 H511100 H511151 H511204 H511251 H511306 H511361 H511419 H511468 H511514 H511102 H511152 H511205 H511253 H511309 H511362 H511420 H511469 H511515 H511103 H511153 H511206 H511255 H511311 H511363 H511424 H511470 H511516 H511104 H511155 H511207 H511256 H511312 H511364 H511425 H511471 H511517 H511105 H511156 H511208 H511257 H511313 H511368 H511426 H511472 H511518 H511106 H511157 H511209 H511258 H511314 H511369 H511427 H511473 H511520 H511108 H511160 H511210 H511259 H511316 H511370 H511428 H511474 H511521 H511109 H511161 H511211 H511260 H511320 H511372 H511429 H511475 H511522 H511110 H511162 H511212 H511261 H511321 H511374 H511430 H511476 H511523 H511111 H511163 H511213 H511262 H511322 H511375 H511431 H511477 H511524 H511112 H511164 H511214 H511264 H511323 H511376 H511432 H511478 H511525 H511113 H511165 H511218 H511265 H511326 H511377 H511433 H511479 H511526 H511528 H511574 H511623 H511675 H511730 H511781 H511838 H511888 H511946 H511529 H511575 H511624 H511676 H511732 H511784 H511840 H511890 H511949 H511530 H511576 H511626 H511677 H511733 H511785 H511841 H511891 H511950 H511531 H511577 H511627 H511678 H511734 H511787 H511842 H511892 H511951 H511532 H511578 H511629 H511679 H511735 H511790 H511844 H511893 H511952 H511533 H511579 H511630 H511681 H511736 H511792 H511845 H511894 H511953 H511534 H511580 H511632 H511682 H511737 H511796 H511846 H511895 H511954 H511535 H511582 H511633 H511683 H511738 H511797 H511847 H511896 H511955 H511536 H511583 H511634 H511686 H511742 H511798 H511848 H511900 H511956 H511537 H511584 H511635 H511687 H511743 H511800 H511849 H511901 H511957 H511538 H511585 H511636 H511688 H511745 H511801 H511850 H511902 H511958 H511540 H511586 H511637 H511690 H511746 H511802 H511851 H511903 H511959 H511541 H511587 H511638 H511691 H511748 H511803 H511852 H511905 H511960 H511542 H511589 H511639 H511694 H511750 H511804 H511853 H511906 H511961 H511543 H511590 H511643 H511695 H511752 H511805 H511854 H511907 H511962 H511544 H511591 H511644 H511696 H511753 H511806 H511855 H511908 H511963 H511545 H511592 H511645 H511697 H511754 H511807 H511856 H511910 H511964 H511546 H511593 H511646 H511698 H511755 H511808 H511857 H511915 H511965 H511547 H511594 H511647 H511699 H511756 H511809 H511859 H511916 H511966 H511548 H511595 H511648 H511700 H511758 H511811 H511860 H511917 H511967 H511549 H511596 H511650 H511701 H511760 H511813 H511861 H511918 H511968 H511550 H511597 H511651 H511702 H511761 H511814 H511863 H511922 H511969 H511551 H511599 H511652 H511703 H511762 H511815 H511864 H511923 H511970 H511552 H511600 H511653 H511704 H511763 H511816 H511865 H511924 H511971 H511553 H511601 H511654 H511705 H511764 H511821 H511868 H511925 H511972 H511554 H511605 H511655 H511707 H511765 H511822 H511869 H511926 H511974 H511555 H511606 H511656 H511711 H511767 H511823 H511870 H511927 H511975 H511556 H511607 H511657 H511712 H511768 H511824 H511872 H511928 H511976 H511557 H511608 H511658 H511713 H511769 H511825 H511873 H511930 H511977 H511558 H511609 H511659 H511714 H511770 H511826 H511874 H511931 H511978 H511559 H511610 H511660 H511715 H511771 H511827 H511875 H511932 H511980 H511561 H511611 H511662 H511716 H511772 H511828 H511876 H511933 H511982 H511563 H511612 H511663 H511719 H511773 H511829 H511878 H511935 H511983 H511564 H511613 H511664 H511720 H511774 H511830 H511879 H511936 H511984 H511565 H511614 H511666 H511722 H511775 H511831 H511880 H511937 H511985 H511566 H511615 H511667 H511723 H511776 H511832 H511881 H511938 H511987 H511569 H511616 H511670 H511724 H511777 H511833 H511882 H511939 H511990 H511570 H511619 H511671 H511726 H511778 H511835 H511883 H511943 H511991 H511572 H511620 H511673 H511727 H511779 H511836 H511884 H511944 H511992 H511573 H511622 H511674 H511728 H511780 H511837 H511886 H511945 H511993 H511994 H512044 H512094 H512156 H512224 H512277 H512328 H512386 H512436 H511995 H512046 H512095 H512157 H512226 H512278 H512329 H512387 H512437 H511996 H512047 H512097 H512161 H512227 H512279 H512331 H512388 H512438 H511998 H512048 H512100 H512163 H512228 H512280 H512332 H512389 H512439 H511999 H512049 H512103 H512165 H512229 H512282 H512334 H512390 H512440 H512000 H512050 H512104 H512166 H512231 H512283 H512335 H512391 H512441 H512001 H512051 H512107 H512168 H512234 H512284 H512337 H512392 H512445 H512002 H512052 H512108 H512169 H512236 H512287 H512339 H512394 H512446 H512003 H512053 H512111 H512171 H512237 H512288 H512340 H512396 H512449 H512004 H512056 H512112 H512180 H512238 H512289 H512341 H512398 H512450 H512005 H512057 H512113 H512182 H512239 H512290 H512342 H512399 H512451 H512006 H512058 H512114 H512184 H512240 H512291 H512344 H512400 H512452 H512007 H512059 H512118 H512185 H512241 H512292 H512345 H512401 H512453 H512008 H512060 H512120 H512186 H512242 H512293 H512347 H512402 H512454 H512010 H512062 H512121 H512187 H512243 H512294 H512349 H512403 H512455 H512011 H512063 H512122 H512188 H512244 H512296 H512350 H512404 H512459 H512012 H512064 H512124 H512190 H512245 H512297 H512354 H512405 H512460 H512013 H512065 H512125 H512191 H512246 H512298 H512355 H512406 H512461 H512014 H512066 H512126 H512194 H512247 H512299 H512356 H512407 H512462 H512016 H512067 H512127 H512197 H512248 H512300 H512357 H512408 H512463 H512017 H512068 H512128 H512198 H512249 H512302 H512358 H512410 H512464 H512019 H512069 H512131 H512199 H512250 H512303 H512360 H512411 H512465 H512020 H512070 H512132 H512200 H512252 H512304 H512361 H512414 H512466 H512021 H512071 H512133 H512201 H512253 H512305 H512362 H512415 H512467 H512022 H512072 H512134 H512202 H512254 H512306 H512364 H512416 H512468 H512024 H512073 H512135 H512203 H512255 H512307 H512365 H512417 H512469 H512028 H512076 H512136 H512204 H512256 H512308 H512366 H512418 H512470 H512029 H512077 H512137 H512205 H512258 H512309 H512367 H512419 H512471 H512031 H512078 H512138 H512206 H512259 H512310 H512368 H512420 H512475 H512032 H512079 H512139 H512207 H512260 H512311 H512369 H512421 H512477 H512033 H512081 H512140 H512208 H512262 H512314 H512371 H512423 H512479 H512035 H512082 H512142 H512210 H512264 H512315 H512372 H512425 H512480 H512036 H512083 H512144 H512211 H512265 H512317 H512375 H512426 H512483 H512037 H512084 H512145 H512212 H512266 H512318 H512376 H512427 H512485 H512038 H512085 H512146 H512213 H512268 H512320 H512377 H512429 H512486 H512039 H512086 H512148 H512214 H512270 H512321 H512378 H512431 H512487 H512040 H512087 H512149 H512218 H512271 H512322 H512379 H512432 H512489 H512041 H512088 H512150 H512219 H512273 H512324 H512380 H512433 H512490 H512042 H512090 H512154 H512222 H512274 H512325 H512381 H512434 H512491 H512043 H512091 H512155 H512223 H512275 H512327 H512385 H512435 H512492 H512495 H512551 H512610 H512671 H512720 H512782 H512839 H512888 H512954 H512496 H512552 H512611 H512674 H512723 H512783 H512841 H512889 H512955 H512497 H512553 H512612 H512675 H512724 H512784 H512842 H512890 H512956 H512498 H512554 H512613 H512676 H512725 H512785 H512843 H512892 H512957 H512502 H512555 H512614 H512677 H512726 H512786 H512845 H512893 H512958 H512503 H512556 H512616 H512678 H512727 H512787 H512846 H512896 H512959 H512504 H512559 H512617 H512679 H512729 H512789 H512847 H512899 H512960 H512506 H512560 H512618 H512680 H512730 H512790 H512848 H512902 H512961 H512507 H512561 H512619 H512681 H512731 H512791 H512849 H512907 H512962 H512509 H512563 H512620 H512682 H512732 H512795 H512850 H512908 H512964 H512511 H512567 H512621 H512683 H512734 H512799 H512852 H512909 H512966 H512513 H512568 H512622 H512684 H512735 H512801 H512853 H512912 H512967 H512515 H512569 H512623 H512685 H512737 H512802 H512854 H512913 H512969 H512516 H512570 H512624 H512686 H512738 H512803 H512855 H512914 H512970 H512517 H512573 H512632 H512691 H512739 H512804 H512856 H512916 H512971 H512518 H512574 H512633 H512692 H512740 H512809 H512858 H512917 H512972 H512520 H512575 H512634 H512693 H512741 H512810 H512859 H512918 H512973 H512521 H512576 H512636 H512694 H512742 H512811 H512860 H512920 H512974 H512522 H512577 H512637 H512695 H512743 H512812 H512861 H512921 H512977 H512524 H512578 H512642 H512697 H512744 H512813 H512862 H512924 H512978 H512525 H512579 H512643 H512698 H512745 H512814 H512863 H512926 H512979 H512526 H512581 H512644 H512700 H512747 H512815 H512864 H512928 H512980 H512527 H512582 H512645 H512701 H512749 H512816 H512865 H512929 H512982 H512532 H512583 H512646 H512702 H512750 H512817 H512866 H512930 H512984 H512533 H512585 H512647 H512703 H512751 H512818 H512867 H512931 H512985 H512534 H512586 H512650 H512704 H512757 H512819 H512868 H512932 H512987 H512535 H512587 H512652 H512705 H512758 H512821 H512869 H512933 H512988 H512536 H512588 H512657 H512706 H512761 H512822 H512873 H512934 H512989 H512537 H512590 H512658 H512707 H512763 H512824 H512874 H512935 H512990 H512538 H512591 H512659 H512708 H512767 H512827,H512875 H512936 H512991 H512539 H512592 H512661 H512709 H512769 H512828 H512878 H512938 H512992 H512540 H512596 H512662 H512710 H512770 H512829 H512879 H512939 H512993 H512541 H512597 H512663 H512711 H512771 H512831 H512880 H512940 H512994 H512542 H512598 H512664 H512712 H512773 H512832 H512881 H512941 H512995 H512543 H512600 H512665 H512713 H512774 H512833 H512882 H512943 H512996 H512545 H512602 H512666 H512714 H512776 H512834 H512883 H512944 H512997 H512546 H512603 H512667 H512716 H512777 H512835 H512884 H512945 H512998 H512547 H512604 H512668 H512717 H512778 H512836 H512885 H512946 H512999 H512548 H512607 H512669 H512718 H512779 H512837 H512886 H512948 H513000 H512550 H512608 H512670 H512719 H512781 H512838 H512887 H512953 H513001 H513002 H513050 H513107 H513156 H513211 H513265 H513312 H513373 H513428 H513004 H513051 H513108 H513157 H513212 H513266 H513315 H513374 H513429 H513005 H513052 H513109 H513158 H513213 H513267 H513317 H513375 H513430 H513006 H513054 H513111 H513162 H513215 H513268 H513321 H513376 H513431 H513008 H513055 H513112 H513163 H513216 H513269 H513322 H513378 H513432 H513009 H513056 H513113 H513164 H513217 H513272 H513323 H513379 H513433 H513010 H513058 H513114 H513165 H513220 H513273 H513325 H513380 H513434 H513011 H513059 H513115 H513166 H513222 H513274 H513326 H513381 H513435 H513012 H513060 H513116 H513167 H513223 H513276 H513327 H513382 H513437 H513014 H513062 H513117 H513170 H513224 H513277 H513329 H513383 H513438 H513015 H513064 H513118 H513171 H513225 H513278 H513330 H513384 H513439 H513016 H513065 H513119 H513172 H513226 H513279 H513331 H513385 H513440 H513018 H513066 H513120 H513174 H513227 H513280 H513338 H513386 H513441 H513019 H513067 H513121 H513176 H513228 H513281 H513339 H513387 H513443 H513020 H513069 H513122 H513180 H513229 H513283 H513340 H513388 H513450 H513021 H513070 H513123 H513181 H513231 H513285 H513341 H513389 H513451 H513022 H513073 H513124 H513182 H513233 H513287 H513342 H513390 H513452 H513023 H513078 H513125 H513183 H513234 H513289 H513344 H513393 H513453 H513024 H513079 H513127 H513184 H513236 H513290 H513345 H513394 H513454 H513025 H513080 H513128 H513185 H513237 H513291 H513347 H513395 H513455 H513026 H513081 H513129 H513186 H513239 H513292 H513349 H513396 H513456 H513027 H513082 H513130 H513188 H513240 H513293 H513350 H513397 H513457 H513028 H513083 H513131 H513189 H513241 H513294 H513351 H513398 H513458 H513029 H513084 H513132 H513190 H513242 H513295 H513353 H513399 H513459 H513030 H513085 H513133 H513191 H513244 H513296 H513354 H513400 H513460 H513031 H513086 H513134 H513192 H513245 H513297 H513355 H513401 H513462 H513032 H513087 H513135 H513193 H513246 H513298 H513356 H513402 H513464 H513033 H513089 H513139 H513195 H513248 H513299 H513357 H513403 H513465 H513034 H513091 H513142 H513196 H513249 H513300 H513358 H513405 H513466 H513035 H513092 H513143 H513197 H513250 H513301 H513359 H513407 H513467 H513036 H513094 H513144 H513199 H513251 H513302 H513360 H513413 H513470 H513037 H513095 H513145 H513200 H513253 H513303 H513361 H513414 H513471 H513039 H513096 H513146 H513201 H513254 H513304 H513362 H513419 H513472 H513042 H513097 H513147 H513202 H513255 H513305 H513363 H513420 H513474 H513043 H513098 H513149 H513203 H513256 H513306 H513365 H513421 H513475 H513045 H513101 H513150 H513204 H513257 H513307 H513366 H513422 H513477 H513046 H513103 H513151 H513205 H513260 H513308 H513367 H513424 H513478 H513047 H513104 H513152 H513208 H513261 H513309 H513369 H513425 H513479 H513048 H513105 H513153 H513209 H513262 H513310 H513371 H513426 H513480 H513049 H513106 H513154 H513210 H513264 H513311 H513372 H513427 H513483 H513485 H513542 H513595 H513647 H513699 H513758 H513816 H513869 H513923 H513492 H513543 H513596 H513648 H513700 H513759 H513817 H513870 H513924 H513493 H513545 H513597 H513649 H513701 H513761 H513818 H513871 H513925 H513494 H513546 H513598 H513650 H513704 H513763 H513819 H513872 H513926 H513495 H513547 H513601 H513651 H513706 H513764 H513821 H513873 H513927 H513496 H513548 H513602 H513653 H513707 H513766 H513822 H513875 H513929 H513497 H513549 H513603 H513654 H513709 H513767 H513823 H513876 H513930 H513498 H513550 H513604 H513656 H513710 H513769 H513825 H513877 H513931 H513499 H513551 H513605 H513657 H513712 H513770 H513826 H513878 H513932 H513501 H513552 H513606 H513658 H513713 H513771 H513827 H513880 H513933 H513502 H513553 H513607 H513659 H513714 H513772 H513828 H513881 H513934 H513503 H513554 H513611 H513660 H513718 H513773 H513829 H513887 H513935 H513504 H513555 H513612 H513661 H513719 H513775 H513830 H513888 H513936 H513506 H513556 H513613 H513663 H513720 H513776 H513831 H513889 H513937 H513507 H513558 H513614 H513664 H513721 H513777 H513832 H513890 H513941 H513508 H513559 H513615 H513665 H513722 H513778 H513837 H513891 H513942 H513509 H513561 H513617 H513667 H513723 H513779 H513838 H513892 H513943 H513511 H513562 H513619 H513668 H513725 H513780 H513839 H513893 H513944 H513514 H513563 H513621 H513669 H513730 H513781 H513840 H513894 H513945 H513515 H513565 H513622 H513670 H513731 H513782 H513841 H513895 H513947 H513516 H513566 H513624 H513672 H513733 H513783 H513842 H513896 H513949 H513517 H513567 H513625 H513673 H513735 H513784 H513843 H513898 H513952 H513518 H513568 H513626 H513674 H513738 H513785 H513844 H513899 H513953 H513519 H513569 H513627 H513675 H513739 H513786 H513845 H513901 H513954 H513520 H513570 H513628 H513676 H513740 H513787 H513846 H513902 H513955 H513521 H513571 H513629 H513677 H513741 H513788 H513847 H513904 H513956 H513523 H513573 H513630 H513679 H513742 H513789 H513850 H513906 H513957 H513524 H513574 H513631 H513680 H513743 H513790 H513853 H513907 H513958 H513525 H513575 H513632 H513681 H513744 H513791 H513854 H513908 H513959 H513526 H513579 H513633 H513682 H513745 H513792 H513855 H513909 H513960 H513527 H513580 H513634 H513683 H513746 H513793 H513856 H513910 H513961 H513528 H513581 H513635 H513684 H513747 H513794 H513857 H513911 H513962 H513529 H513582 H513636 H513686 H513748 H513795 H513858 H513912 H513963 H513530 H513583 H513638 H513687 H513749 H513797 H513859 H513913 H513964 H513533 H513584 H513639 H513690 H513750 H513800 H513860 H513914 H513965 H513534 H513585 H513640 H513691 H513751 H513801 H513861 H513916 H513966 H513535 H513586 H513641 H513693 H513753 H513802 H513862 H513917 H513967 H513536 H513589 H513642 H513695 H513755 H513805 H513863 H513919 H513968 H513539 H513591 H513645 H513696 H513756 H513807 H513866 H513921 H513969 H513541 H513594 H513646 H513697 H513757 H513815 H513867 H513922 H513970 H513971 H514018 H514071 H514124 H514170 H514221 H514268 H514321 H514366 H513972 H514019 H514072 H514125 H514171 H514222 H514269 H514322 H514367 H513973 H514020 H514073 H514126 H514172 H514223 H514270 H514323 H514369 H513974 H514021 H514075 H514127 H514174 H514224 H514271 H514325 H514372 H513975 H514022 H514077 H514128 H514175 H514225 H514272 H514326 H514373 H513976 H514023 H514078 H514129 H514179 H514226 H514273 H514329 H514374 H513977 H514024 H514079 H514130 H514180 H514227 H514274 H514330 H514375 H513978 H514025 H514080 H514133 H514181 H514228 H514276 H514331 H514376 H513979 H514026 H514081 H514134 H514182 H514229 H514277 H514332 H514377 H513980 H514028 H514082 H514135 H514183 H514230 H514278 H514333 H514378 H513981 H514029 H514083 H514136 H514184 H514231 H514279 H514334 H514379 H513982 H514030 H514084 H514137 H514185 H514232 H514280 H514335 H514380 H513983 H514031 H514085 H514138 H514186 H514233 H514281 H514336 H514381 H513984 H514032 H514086 H514140 H514187 H514234 H514282 H514337 H514382 H513985 H514033 H514087 H514141 H514188 H514235 H514283 H514338 H514383 H513986 H514034 H514089 H514142 H514189 H514236 H514284 H514339 H514385 H513987 H514039 H514090 H514143 H514190 H514237 H514285 H514340 H514386 H513988 H514041 H514091 H514144 H514191 H514238 H514286 H514341 H514387 H513989 H514042 H514092 H514145 H514192 H514239 H514289 H514342 H514388 H513990 H514047 H514093 H514146 H514193 H514240 H514291 H514343 H514389 H513991 H514048 H514094 H514147 H514194 H514241 H514292 H514344 H514390 H513992 H514050 H514095 H514148 H514196 H514243 H514293 H514345 H514391 H513993 H514051 H514096 H514149 H514197 H514244 H514296 H514346 H514392 H513995 H514052 H514097 H514152 H514198 H514245 H514297 H514347 H514395 H513999 H514053 H514098 H514153 H514200 H514246 H514300 H514348 H514396 H514000 H514054 H514099 H514154 H514202 H514247 H514301 H514349 H514397 H514001 H514055 H514100 H514155 H514203 H514248 H514303 H514350 H514398 H514002 H514056 H514101 H514156 H514204 H514249 H514304 H514351 H514399 H514003 H514058 H514102 H514157 H514209 H514250 H514305 H514352 H514400 H514004 H514059 H514103 H514158 H514210 H514253 H514306 H514353 H514402 H514005 H514060 H514104 H514159 H514211 H514254 H514307 H514355 H514403 H514007 H514062 H514108 H514160 H514212 H514256 H514308 H514357 H514404 H514008 H514063 H514110 H514162 H514213 H514257 H514310 H514358 H514405 H514009 H514064 H514112 H514163 H514214 H514258 H514311 H514359 H514406 H514010 H514065 H514114 H514164 H514215 H514260 H514313 H514360 H514407 H514011 H514066 H514115 H514165 H514216 H514261 H514314 H514361 H514408 H514013 H514067 H514119 H514166 H514217 H514262 H514315 H514362 H514409 H514015 H514068 H514121 H514167 H514218 H514263 H514316 H514363 H514410 H514016 H514069 H514122 H514168 H514219 H514265 H514318 H514364 H514411 H514017 H514070 H514123 H514169 H514220 H514266 H514319 H514365 H514412 H514413 H514472 H514527 H514580 H514626 H514670 H514768 H515035 H515081 H514414 H514474 H514528 H514581 H514627 H514671 H514770 H515036 H515082 H514415 H514475 H514529 H514582 H514628 H514672 H514779 H515037 H515085 H514416 H514478 H514530 H514583 H514629 H514673 H514780 H515038 H515086 H514417 H514479 H514532 H514584 H514631 H514675 H514784 H515039 H515087 H514420 H514480 H514533 H514586 H514632 H514676 H514785 H515040 H515089 H514421 H514483 H514534 H514588 H514633 H514678 H514787 H515041 H515090 H514422 H514484 H514539 H514589 H514634 H514679 H514790 H515042 H515092 H514424 H514485 H514540 H514590 H514635 H514683 H514791 H515043 H515093 H514425 H514486 H514541 H514591 H514636 H514685 H514793 H515044 H515094 H514426 H514487 H514542 H514592 H514637 H514687 H514858 H515045 H515095 H514427 H514488 H514543 H514596 H514638 H514688 H515000 H515046 H515096 H514428 H514489 H514544 H514597 H514639 H514689 H515004 H515047 H515097 H514429 H514490 H514545 H514598 H514640 H514690 H515005 H515048 H515098 H514430 H514491 H514546 H514599 H514641 H514691 H515006 H515049 H515099 H514433 H514493 H514547 H514600 H514642 H514692 H515007 H515050 H515100 H514435 H514496 H514551 H514601 H514643 H514693 H515008 H515051 H515101 H514436 H514498 H514552 H514602 H514644 H514696 H515009 H515052 H515102 H514437 H514499 H514553 H514603 H514645 H514698 H515011 H515054 H515103 H514438 H514501 H514554 H514604 H514647 H514699 H515012 H515055 H515104 H514439 H514502 H514555 H514605 H514648 H514703 H515013 H515056 H515107 H514440 H514504 H514556 H514606 H514649 H514705 H515014 H515057 H515108 H514441 H514506 H514557 H514607 H514651 H514708 H515015 H515060 H515109 H514442 H514507 H514559 H514608 H514652 H514711 H515016 H515062 H515110 H514444 H514508 H514560 H514609 H514653 H514715 H515017 H515063 H515111 H514455 H514510 H514561 H514611 H514654 H514716 H515018 H515064 H515112 H514456 H514511 H514562 H514612 H514655 H514722 H515019 H515065 H515113 H514457 H514513 H514563 H514613 H514656 H514724 H515020 H515067 H515114 H514460 H514514 H514564 H514614 H514657 H514732 H515021 H515068 H515115 H514461 H514515 H514565 H514615 H514658 H514734 H515022 H515069 H515116 H514462 H514516 H514566 H514616 H514660 H514735 H515023 H515070 H515117 H514463 H514517 H514567 H514617 H514661 H514736 H515025 H515071 H515119 H514464 H514518 H514568 H514618 H514662 H514750 H515026 H515072 H515120 H514465 H514520 H514571 H514619 H514663 H514752 H515027 H515073 H515121 H514466 H514521 H514574 H514620 H514664 H514753 H515029 H515075 H515122 H514467 H514522 H514575 H514621 H514665 H514754 H515030 H515076 H515125 H514468 H514523 H514576 H514622 H514666 H514756 H515031 H515077 H515126 H514469 H514524 H514577 H514623 H514667 H514763 H515032 H515078 H515127 H514470 H514525 H514578 H514624 H514668 H514765 H515033 H515079 H515128 H514471 H514526 H514579 H514625 H514669 H514766 H515034 H515080 H515129 H515131 H515203 H515133 H515204 H515134 H515205 H515135 H515206 H515136 H515207 H515137 H515208 H515138 H515209 H515139 H515210 H515140 H515213 H515141 H515214 H515145 H515215 H515148 H515218 H515149 H515219 H515150 H515221 H515152 H515223 H515155 H515225 H515156 H515228 H515157 H515231 H515159 H515236 H515160 H515237 H515162 H515240 H515163 H515242 H515165 H515243 H515171 H515249 H515175 H515256 H515178 H515259 H515179 H515262 H515181 H515266 H515184 H515269 H515185 H515276 H515189 H515293 H515190 H516012 H515191 H517567 H515192 H519999 H515193 H515196 H515197 H515198 H515200 H515201
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 16, 2009. Firm initiated recall is ongoing.
REASON
Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.
VOLUME OF PRODUCT IN COMMERCE
3,629 units
DISTRIBUTION
Nationwide, Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia
___________________________________
PRODUCT
Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72. The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy. Recall # Z-0892-2011
CODE
Serial Numbers: The last four digits represent the serial number of the device. H720003 H720119 H720209 H720270 H720347 H720416 H720491 H720557 H720618 H720006 H720122 H720210 H720271 H720348 H720417 H720495 H720558 H720620 H720009 H720123 H720211 H720273 H720350 H720419 H720496 H720559 H720622 H720013 H720124 H720213 H720274 H720351 H720422 H720498 H720560 H720624 H720015 H720125 H720215 H720276 H720352 H720424 H720499 H720561 H720626 H720017 H720129 H720217 H720279 H720353 H720425 H720500 H720562 H720627 H720021 H720132 H720218 H720280 H720354 H720427 H720501 H720563 H720628 H720022 H720133 H720219 H720281 H720355 H720429 H720502 H720565 H720629 H720025 H720134 H720221 H720282 H720357 H720432 H720503 H720566 H720632 H720035 H720137 H720222 H720283 H720358 H720435 H720505 H720567 H720637 H720037 H720138 H720225 H720284 H720362 H720437 H720506 H720568 H720638 H720040 H720140 H720229 H720288 H720363 H720438 H720508 H720571 H720639 H720041 H720143 H720230 H720289 H720367 H720439 H720509 H720572 H720641 H720048 H720144 H720231 H720290 H720373 H720440 H720511 H720573 H720642 H720051 H720145 H720232 H720292 H720374 H720442 H720513 H720575 H720643 H720052 H720148 H720233 H720293 H720375 H720443 H720514 H720577 H720644 H720056 H720152 H720234 H720294 H720376 H720445 H720515 H720578 H720647 H720057 H720154 H720235 H720295 H720379 H720447 H720516 H720579 H720648 H720059 H720157 H720236 H720296 H720383 H720449 H720518 H720584 H720650 H720060 H720159 H720237 H720297 H720384 H720452 H720522 H720585 H720651 H720064 H720164 H720239 H720298 H720386 H720457 H720523 H720586 H720653 H720069 H720165 H720241 H720299 H720388 H720458 H720525 H720588 H720654 H720070 H720167 H720242 H720300 H720391 H720461 H720526 H720589 H720659 H720071 H720168 H720245 H720303 H720392 H720465 H720528 H720590 H720660 H720072 H720169 H720247 H720307 H720394 H720466 H720530 H720591 H720661 H720074 H720177 H720248 H720309 H720395 H720470 H720531 H720592 H720663 H720075 H720180 H720251 H720316 H720396 H720471 H720533 H720594 H720664 H720082 H720181 H720254 H720320 H720397 H720472 H720534 H720595 H720666 H720083 H720182 H720255 H720327 H720399 H720477 H720536 H720596 H720667 H720088 H720183 H720256 H720328 H720402 H720478 H720537 H720597 H720668 H720089 H720185 H720257 H720329 H720403 H720479 H720539 H720598 H720669 H720092 H720186 H720258 H720330 H720404 H720481 H720546 H720599 H720670 H720098 H720187 H720261 H720336 H720405 H720482 H720547 H720600 H720671 H720101 H720188 H720262 H720337 H720406 H720484 H720548 H720601 H720672 H720106 H720195 H720263 H720338 H720407 H720485 H720550 H720604 H720673 H720107 H720196 H720264 H720339 H720409 H720486 H720553 H720605 H720674 H720108 H720199 H720265 H720344 H720411 H720487 H720554 H720608 H720675 H720112 H720200 H720266 H720345 H720414 H720488 H720555 H720615 H720676 H720113 H720204 H720269 H720346 H720415 H720489 H720556 H720616 H720678 H720679 H720743 H720805 H720858 H720905 H720955 H721005 H720680 H720744 H720806 H720859 H720906 H720956 H721006 H720681 H720746 H720807 H720860 H720907 H720957 H721007 H720682 H720747 H720808 H720861 H720908 H720958 H721008 H720683 H720748 H720809 H720862 H720909 H720959 H721009 H720684 H720749 H720810 H720863 H720910 H720960 H721010 H720686 H720750 H720811 H720864 H720911 H720961 H721011 H720688 H720752 H720812 H720865 H720913 H720962 H721012 H720689 H720754 H720813 H720866 H720914 H720963 H721013 H720692 H720756 H720814 H720867 H720915 H720964 H721014 H720693 H720759 H720815 H720868 H720916 H720965 H721015 H720694 H720760 H720816 H720869 H720918 H720966 H721016 H720697 H720761 H720817 H720870 H720919 H720967 H721017 H720699 H720763 H720818 H720871 H720920 H720968 H721018 H720701 H720766 H720819 H720872 H720921 H720969 H721019 H720702 H720767 H720820 H720873 H720922 H720974 H721020 H720704 H720769 H720822 H720874 H720923 H720975 H721022 H720705 H720770 H720823 H720875 H720925 H720976 H721023 H720706 H720773 H720824 H720876 H720926 H720977 H721024 H720707 H720774 H720825 H720877 H720927 H720978 H721025 H720711 H720775 H720826 H720878 H720928 H720979 H721026 H720712 H720776 H720827 H720879 H720929 H720980 H721027 H720714 H720777 H720829 H720880 H720930 H720981 H721028 H720715 H720778 H720830 H720881 H720931 H720982 H721029 H720716 H720780 H720831 H720882 H720932 H720983 H721030 H720718 H720781 H720832 H720883 H720933 H720984 H721031 H720719 H720782 H720833 H720884 H720935 H720985 H721032 H720720 H720783 H720834 H720885 H720936 H720986 H721033 H720721 H720784 H720835 H720886 H720937 H720987 H721034 H720722 H720786 H720836 H720888 H720938 H720988 H721035 H720723 H720787 H720840 H720889 H720940 H720989 H721036 H720724 H720788 H720841 H720890 H720941 H720990 H721037 H720725 H720790 H720842 H720891 H720942 H720991 H721038 H720726 H720792 H720843 H720892 H720943 H720992 H721039 H720727 H720795 H720844 H720894 H720945 H720993 H721040 H720728 H720796 H720847 H720895 H720946 H720995 H721041 H720729 H720797 H720848 H720896 H720947 H720996 H721042 H720732 H720798 H720849 H720897 H720948 H720997 H721043 H720733 H720799 H720851 H720898 H720949 H720998 H721044 H720734 H720800 H720852 H720899 H720950 H720999 H721045 H720737 H720801 H720854 H720901 H720951 H721000 H721046 H720739 H720802 H720855 H720902 H720952 H721001 H721047 H720741 H720803 H720856 H720903 H720953 H721002 H721048 H720742 H720804 H720857 H720904 H720954 H721004
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on January 19, 2010. Firm initiated recall is ongoing.
REASON
There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.
VOLUME OF PRODUCT IN COMMERCE
674 units
DISTRIBUTION
Nationwide, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.
___________________________________
PRODUCT
Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL. Port VAD Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. 3540CL. The kits are used by blood centers to draw blood. Recall # Z-0894-2011
CODE
Lot 912024, 1004229, 1007091; Lot 1001066
RECALLING FIRM/MANUFACTURER
Continental Medical Labs, Inc., Waterford, WI, by letters dated November 12, 2010 and December 7, 2010, and by telephone on December 6, 2010. Firm initiated recall is ongoing.
REASON
Testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.
VOLUME OF PRODUCT IN COMMERCE
30 cases (900 kits/case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Disc Space Distractor Label states - Specialty Disc Space Distractor, Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. Instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue. Catalog number # IS2346AVS. Recall # Z-0895-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, letter dated December 7, 2010,
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
AZ, FL, MA, NY, PA, and TX
___________________________________
PRODUCT
Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation. Recall # Z-0898-2011
CODE
Lot/Serial Number: CF9065974
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letters dated November 9, 2010.
Manufacturer: Teleflex Medical de Mexico, Chihuahua Chih, Mexico. Firm initiated recall is ongoing.
REASON
One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.
VOLUME OF PRODUCT IN COMMERCE
1,150 units
DISTRIBUTION
Argentina and Columbia
___________________________________
PRODUCT
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072. Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty. Recall # Z-0899-2011
CODE
Lot numbers 33367 and 33407
RECALLING FIRM/MANUFACTURER
Concentric Medical Inc., Mountain View, CA, by letter on February 27, 2009. Firm initiated recall is complete.
REASON
Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, WV, Turkey and Switzerland
___________________________________
PRODUCT
Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient. Recall # Z-0900-2011
CODE
K061905; Versions 12, 12 SP1, 12 SP1 HF2, 12 SP1 HF4, 12.1, 12.1 HF1, 12.1 HF2
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson Provider Technologies - Medical Imaging Group, Parsippany, NJ, by letters dated June 16, 2010 and letters sent from August 30, 2010 to September 28, 2010.
Manufacturer: Medcon LTD., Tel Aviv, Israel. Firm initiated recall is ongoing.
REASON
When importing ECG files from Mortara ECG carts using DICOM interface, the Horizon Cardiology ECG Management System does not display the amplitudes of the waveform properly.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
AZ, CA, FL, GA, MA, PA, UT, WI
___________________________________
PRODUCT
1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011;
2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Bunnell, Inc., Salt Lake City, UT, by letter starting October 22, 2010. Firm initiated recall is ongoing.
REASON
Product software coding error may compromise patient safety.
VOLUME OF PRODUCT IN COMMERCE
660 units
DISTRIBUTION
Nationwide, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay
___________________________________
PRODUCT
PROCEED Surgical Mesh; Product Code PCDG1. Used for the repair of hernias and other fascial deficiencies that requires the addition of a reinforcing or bridging material to obtain the desired surgical result. Recall # Z-0903-2011
CODE
Lot number BMG618
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters on October 18, 2010.
Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.
REASON
There is a potential for delamination in one lot of Proceed surgical mesh
VOLUME OF PRODUCT IN COMMERCE
87 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
VISU 200 on S8 Floor Stand: Surgical microscope used during opthalmic surgeries, which allows real time visualization of the surgical area. Recall # Z-0904-2011
CODE
User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en
RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec Inc., Dublin, CA, letter dated May 18, 2009. Firm initiated recall is ongoing.
REASON
Potential Retina Damage - An error in the user manual may result in misapplied filter and injury during treatment.
VOLUME OF PRODUCT IN COMMERCE
2540 units
DISTRIBUTION
Nationwide and UK
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter. Recall # Z-0719-2011
CODE
Serial numbers: DYTA0001, DYTA0002, DYTA0003, DYTA0007, DYTA0008, DYTA0011, DYTA0012, DYTA0015, DYTA0016, DYTA0017, DYTA0018, DYTA0019, DYTA0020, DYTA0021, DYTA0022, DYTA0024, DYTA0025, DYTA0027, DYTA0028, DYTA0029, DYTA0030, DYTA0031, DYTA0032, DYTA0033, DYTA0034, DYTA0036, DYTA0037, DYTA0038, DYTA0039, DYTA0040, DYTA0041, DYTA0042, DYTA0043, DYTA0044, DYTA0045, DYTA0046, DYTA0047, DYTA0049, DYTA0050, DYTA0051, DYTA0052, DYTA0053, DYTA0054, DYTA0056, DYTA0057, DYTA0058, DYTA0059, DYTA0060, DYTB0001, DYTB0003, DYTB0004, DYTB0005, DYTB0009, DYTB0010, DYTB0011, DYTB0012, DYTB0013, DYTB0015, DYTB0016, DYTB0020, DYTB0021, DYTB0022, DYTB0023, DYTB0024, DYTB0025, DYTB0026, DYTB0027, DYTB0029, DYTB0030, DYTB0031, DYTB0033, DYTB0038, DYTC0001, DYTC0004, DYTC0010, DYTC0011, DYTC0016, DYTC0017, DYTC0018, DYTC0019, DYTC0020, DYTC0021, DYTC0022, DYTC0024, DYTC0025, DYTC0026, DYTC0027, DYTC0029, DYTC0030, DYTC0031, DYTC0032, DYTC0033, DYTC0034, DYTC0035, DYTC0036, DYTC0037, DYTC0038, DYTC0039, DYTC0040, DYUC0001, DYUC0002, DYUC0004, DYUC0005, DYUC0009, DYUC0012, DYUC0014, DYUC0015, DYUC0016, DYUC0017, DYUC0018, DYUC0019, DYUC0020, DYUD0001, DYUD0002, DYUD0003, DYUD0004, DYUD0005, DYUD0006, DYUD0007, DYUD0008, DYUD0009, DYUD0011, DYUD0012, DYUD0013, DYUD0014, DYUD0015, DYUD0016, DYUD0017, DYUD0019, DYUD0020, DYUD0021, DYUD0022, DYUD0023, DYUD0026, DYUD0027, DYUD0028, DYUD0029, DYUD0030, DYUD0031, DYUD0033, DYUD0034, DYUD0035, DYUD0036, DYUD0037, DYUD0038, DYUD0039, DYUD0042, DYUD0043, DYUD0045, DYUD0046, DYUD0047, DYUD0048, DYUD0049, DYUD0050, DYUD0052, DYUD0053, DYUD0055, DYUD0057, DYUD0058, DYUD0059, DYUE0002, DYUE0007, DYUE0008, DYUE0011, and DYUE0014
RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R. Bard, Inc., Urological Division, Covington, GA, by letter on/about November 18, 2010.
Manufacturer: Dymax Corp., Warrendale, PA. Firm initiated recall is ongoing.
REASON
Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.
VOLUME OF PRODUCT IN COMMERCE
234 units
DISTRIBUTION
Nationwide, Netherlands, and Japan
___________________________________
PRODUCT
Steris Reliance EPS Endoscope Processing System. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices. Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081. Recall # Z-0823-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated July 2, 2010.
Manufacturer: Steris Canada, Beauport, Canada. Firm initiated recall is ongoing.
REASON
Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced.
VOLUME OF PRODUCT IN COMMERCE
936 units
DISTRIBUTION
Nationwide and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom
___________________________________
PRODUCT
Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to apply hot keys from a keypad versus a keyboard. Recall # Z-0835-2011
CODE
Unit: 504RU000
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated October 22, 2010.
Manufacturer: Techprint Inc., Lawrence, MA. Firm initiated recall is complete.
REASON
Product did not receive UL Certification.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
FL, GA, KY, ME, MD, MS, OH, UT and Canada
___________________________________
PRODUCT
Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3. Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms. Recall # Z-0836-2011
CODE
All codes start with HZ3: 0001, 0021, 0032, 0033, 0044, 0403, 0404, 0407, 0422, 0426, 0681, 0684, 0698, 0703, 0727, 2035, 2036, 2037, 2039, 2040, 2126, 3020, 3021, 3022, 3026, 9016, 9018, 9066, 9071, 9165, 0054, 0058, 0061, 0077, 0108, 0110, 0111, 0112, 0131, 0139, 0144, 0154, 0167, 0171, 0178, 0182, 0190, 0207, 0208, 0224, 0230, 0251, 0258, 0265, 0273, 0280, 0283, 0293, 0294, 0312, 0330, 0342, 0349, 0368, 0398, 0460, 0461, 0462, 0485, 0495, 0500, 0507, 0508, 0509, 0510, 0511, 0513, 0520, 0531, 0537, 0540, 0556, 0557, 0571, 0572, 0573, 0588, 0594, 0604, 0612, 0617, 0620, 0624, 0630, 0640, 0646, 0649, 0656, 0670, 0675, 0730, 0731, 0737, 0740, 0743, 0762, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2012, 2013, 2014, 2016, 2017, 2018, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2027, 2028, 2029, 2032, 2033, 2034, 2042, 2044, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2058, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2067, 2069, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2084, 2086, 2108, 2125, 3030, 3031, 3039, 3041, 3042, 3044, 3046, 3047, 3049, 3050, 3053, 3055, 3059, 3062, 3064, 5070, 6101, 6102, 6302, 6303, 7002, 7003, 7005, 7007, 7010, 7011, 7015, 7027, 7101, 8006, 8062, 9002, 9004, 9007, 9010
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on March 23, 2010. Firm initiated recall is ongoing.
REASON
Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
VOLUME OF PRODUCT IN COMMERCE
218
DISTRIBUTION
Nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
___________________________________
PRODUCT
1) Universal Feeds U Turkey Gb Starter KR in 50 lb. paper sacks with plastic liner, ambient storage, Product Numbers U332095, K52105 and U52105. Recall # V-098-2011;
2) Kruse's Perfection K Gamebird/Turkey Grow Crum in 50 lb. paper sacks with plastic liner, ambient storage, Product Numbers U332095, K52105 and U52105. Recall # V-099-2011
CODE
1) and 2) Lot codes 126, 127 and 175
RECALLING FIRM/MANUFACTURER
Western Milling LLC, Goshen, CA, by telephone, and visits on September 27, 2010. Firm initiated recall is ongoing.
REASON
Non-medicated product contains monensin and may result in death of turkeys.
VOLUME OF PRODUCT IN COMMERCE
1229 50-lb sacks total
DISTRIBUTION
CA, NV, HI, AZ
END OF ENFORCEMENT REPORT FOR JANUARY 19, 2011
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