Safety
Enforcement Report for May 27, 2009
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
May 27, 2009
09-21
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
a) Peanuts, all sizes, brands and varieties, packed in bulk 25, 30, 40, and 50 pound cases, 110.23 pound bags, and totes. Recall # F-171-9;
b) Raw and Raw Blanched Peanuts all sizes, brands and varieties packaged in bulk in 25 and 30 pound cases, 110.23 pound bags and in totes. Recall # F-172-9;
c) Peanuts, Chopped or Granulated, all sizes, brands and varieties, packed in bulk in 25, 30, 42.55, and 50 pound cases, 110.23 pound bags, and 1500 pound totes. Recall # F-173-9;
d) Peanut Meal in 30 pound cases. Recall # F-174-9
CODE
Plainview products: All lots; lot number consists of a "T" followed by single digit year (7, 8 or 9) and Julian date.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Peanut Corp. of America, Lynchburg, VA, by an Emergency Order on February 12, 2009.
Manufacturer: Peanut Corporation of America (PCA), Plainview, TX. Firm initiated recall is ongoing.
REASON
The products were recalled by Peanut Corporation of America (PCA) because they may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
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PRODUCT
Hannaford brand Chocolate Chip Ice Cream, one half gallon; UPC 4126811759. Recall # F-235-9
CODE
Lot: SR L1 26-426 08319
RECALLING FIRM/MANUFACTURER
House of Flavors, Inc. Ludington, MI, by press release and email on January 28, 2009. Firm initiated recall is complete.
REASON
The ice cream contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
750 cartons
DISTRIBUTION
FL
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PRODUCT
a) Turkey Hill Tin Roof Sundae Premium Ice Cream in 1.5 quart containers. The product is shipped 6 containers per case. UPC 0-20735-11013-3. Recall # F-236-9;
b) Turkey Hill Light Stuff’d Chocolate Nutty Moose Tracks Ice Cream in pint containers. The product is shipped 8 containers per case. UPC 0-20735-42080-5. Recall # F-237-9;
c) Turkey Hill Chocolate Nutty Moose Tracks Light Recipe Ice Cream in 1.5 quart containers. The product is shipped 6 containers per case. UPC 0-20735-12122-1. Recall # F-238-9;
d) Turkey Hill Peanut Brittle No Sugar Added Recipe Light Ice Cream in 1.5 quart containers. The product is shipped 6 containers per case. UPC 0-20735-13506-8. Recall # F-239-9;
e) Turkey Hill Peanut Butter Mania Light Recipe Ice Cream in 1.5 quart containers. The product is shipped 6 containers per case. UPC 0-20735-12116-0. Recall # F-240-9;
f) Turkey Hill Nutty Carmel Caribou Frozen Yogurt Limited Edition in 1.5 quart containers. The product is shipped 6 containers per case. UPC 0-20735-12505-2. Recall # F-241-9
CODE
a) Sell By Codes 08/09/2009 through 01/20/2010;
b) Sell By Codes 10/09/2009 through 01/19/2010;
c) Sell By Codes 08/05/2009 through 01/06/2010;
d) Sell By Codes 01/01/2008 through 12/12/2009;
e) Sell By Codes 08/09/2009 through 01/20/2010;
f) Sell By Codes 11/25/2009 through 12/19/2009
RECALLING FIRM/MANUFACTURER
Turkey Hill Dairy Inc. Conestoga, PA, by press release and telephone on January 30, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter and peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,319,710 units
DISTRIBUTION
Nationwide
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PRODUCT
Big City Gourmet Candy Bar Thumbprint Cookies, Peanut Shortbread Cookies Filled with Creamy Caramel and Topped with Chocolate and Peanuts; 30 cookies per box, Net Wt. 35 oz. (989g); UPC 8 15895 00276 9. Recall # F-242-9
CODE
01/27/09, 01/28/09, 01/29/09
RECALLING FIRM/MANUFACTURER
Little Miss Muffin, Chicago, IL, by fax and telephone on January 30, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
70 boxes
DISTRIBUTION
IL
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PRODUCT
Hill & Valley Premium Bakery Sugar Free Peanut Butter Cookies, Net Wt. 15 oz. (425 g); baked cookies packaged in a 15 oz. clear plastic clamshell container, 8 packages per case, which are then frozen, and finally thawed and sold at the retail store's bakery shop; 15 oz. retail package - UPC 0 14821 20121 8, case UPC 0 14821 20881 1. Recall # F-243-9
CODE
Item #20881, production dates 01/21/09 through 01/13/09
RECALLING FIRM/MANUFACTURER
Hill and Valley Inc. Rock Island, IL, by telephone and follow-up letters beginning January 29, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,218 cases
DISTRIBUTION
GA, IL, OH, OR, VA
___________________________________
PRODUCT
Kroger Lite Mayo sold in 32 oz jars; UPC 11110 66090. Recall # F-244-9
CODE
"Sell by" date of SEP-25-09
RECALLING FIRM/MANUFACTURER
The Kroger Co., Cincinnati, OH, by e-mail and press release on March 31, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using liquid pasteurized egg that was found positive for Salmonella
VOLUME OF PRODUCT IN COMMERCE
1,957 cases/12/32 oz. jars
DISTRIBUTION
GA, IN, KS, KY, OH, TX, VA
___________________________________
PRODUCT
a) Mrs. Grissom's Salads, Premium Cheese Spread, Net wt. 11oz, 24oz, 48oz, and 5lb (bulk); UPC: 11 oz., 0-75446-01106-4 , 24 oz., 0-75446-01116-3 , 48 oz., 0-75446-00150-8 , 5 lb, 0-75446-00126-3. Recall # F-245-9;
b) Mrs. Grissom's Salads, Original Recipe Pimento Cheese Salad, packaged in 11 oz and 5 lb plastic tubs (bulk); UPC:, 11 oz., 0-75446-01104-0, 5 lb, 0-75446-00123-2. Recall # F-246-9;
c) Mrs. Grissom's Salads, Hot Jalapeno Cheese Spread or dip, packaged in 11 oz plastic containers; UPC: 0-75446-01107-1. Recall # F-247-9;
d) Mrs. Grissom's Dips, Jalapeno, Hot Cheese Dip, packaged in 8 oz plastic containers; UPC: 0-75446-00176-8; Recall # F-248-9
e) Mrs. Grissom's Dips, Gar-licious, Garlic & Onion Flavor Cheese Dip, packaged in 8 oz plastic containers; UPC: 0-75446-00175-1. Recall # F-249-9;
f) Mrs. Grissom's Dips, Cheese n' Cheese, Double Cheese Dip, packaged in 8 oz plastic containers; UPC: 0-75446-00179-1. Recall # F-250-9;
g) Grace's HomeStyle, Pimento Sandwich Spread, packaged in 11 oz and 24 oz plastic tubs; UPC: 11 oz., 0-75446-00153-9, 24 oz., 0-75446-00152-2. Recall # F-251-9;
h) Grace's HomeStyle, Hot Jalapeno Pimento Spread or Dip, packaged in 11 oz plastic tubs. UPC: 0-75446-00163-8. Recall # F-252-9
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Mrs. Grissom's Salads, Inc. Nashville, TN, by press release and letter on April 9, 2009. Firm initiated recall is ongoing.
REASON
Undeclared allergen – fish.
VOLUME OF PRODUCT IN COMMERCE
331,787 units
DISTRIBUTION
KY, IN, TN, AL, MS, GA, WV
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
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PRODUCT
Morphine Sulfate Immediate Release Tablets 15mg used as rescue medication in kits for clinical study KF5503/16, 100 count bottles, Clinical study KF5503/16. Recall # D-420-2009
CODE
Ethex Lot number: 81746
RECALLING FIRM/MANUFACTURER
Recalling Firm: Almac Clinical Services LLC, Norristown, PA, by letter and FDA press release on January 15, 2009.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, Mo. Firm initiated recall is complete.
REASON
Tablet Thickness; possibility of oversized tablets which could result in superpotent dose.
VOLUME OF PRODUCT IN COMMERCE
1,070 bottles
DISTRIBUTION
CA, FL, IN, LA, NC, NY, OH, PA, TX, Argentina, Chile, France, Latvia, and Ukraine
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
Metoprolol Tartrate Tablets USP, 100 mg, 1000 count bottles, Rx only, NDC number 0093-0734-10. Recall # D-419-2009
CODE
Lot numbers 505514 exp 1/2010, 505515 exp 1/2010, 505516 exp 1/2010, and 505517 exp 1/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc. Sellersville, PA, by letter on April 1, 2009.
Manufacturer: Teva Pharmaceuticals Industries, Ltd. Kfar Sava, Israel. Firm initiated recall is ongoing.
REASON
The affected lots may contain some tablets exceeding weight requirements.
VOLUME OF PRODUCT IN COMMERCE
2,108 bottles
DISTRIBUTION
Nationwide
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PRODUCT
Zicam Multisymptom Cold & Flu Nighttime Formula, (Acetaminophen 325mg, Detromethorphan HBr 10mg and Guaifenesin 200mg) 8oz bottle. NDC 62750-023-10; UPC code: "7 32216 30032 1. Recall # D-421-2009
CODE
Lot: MSN8287-1, EXP 10/10
RECALLING FIRM/MANUFACTURER
Unicep Packaging Inc. Sandpoint, ID, by letter dated March 19, 2009. Firm initiated recall is ongoing.
REASON
Mislabeled; some bottles in the lot contain an incorrect Drug Facts panel on the back of the bottle. Bottle labeled as containing Guaifenesin actually contains Doxylamine Succinate.
VOLUME OF PRODUCT IN COMMERCE
20,365 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
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PRODUCT
a) Fresh Frozen Plasma. Recall # B-0722-09;
b) Platelets Leukocytes Reduced. Recall # B-0723-09
CODE
a) and b) Unit: 13GL37124
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on December 21, 2006 and follow-up letter dated March 1, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0794-09
CODE
Unit: 0420127
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 16, 2007 and by letter on October 29, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0912-09
CODE
Unit: 9575372
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 30, 2008, and by electronic mail, letter and Fax on January 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-0922-09;
b) Recovered Plasma. Recall # B-0923-09;
c) Red Blood Cells. Recall # B-0924-09
CODE
a), b), and c) Unit: W120608300330
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on December 15, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area considered at risk for HIV-Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, MI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0925-09;
b) Plasma Frozen. Recall # B-0926-09;
CODE
a) and b) Unit: 19LJ45564
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile and telephone on November 7, 2008 and by letter on December 19, 2008 and January 22, 2009. 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
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0927-09
CODE
Unit: 9050746
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated December 16, 2008 and by telephone on January 30, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0928-09;
b) Red Blood Cells. Recall # B-0929-09;
c) Fresh Frozen Plasma. Recall # B-0930-09
CODE
a) Unit: 2433991;
b) Units: 2439065, 2418136, 2413560;
c) Units: 2439065, 2433991, 2418136, 2413560
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated December 5, 2008 and by telephone on January 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OH, IN
___________________________________
PRODUCT
a) Red Blood Cells. Recall # B-0932-09;
b) Cryoprecipitated AHF, Pooled. Recall # B-0933-09;
c) Plasma Frozen Cryoprecipitated Reduced. Recall # B-0934-09
CODE
a), b) and c) Unit: 0501114
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated December 23, 2008 and by electronic mail on March 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced, Recall # B-0941-09
CODE
Pool # 12091 (containing units 2448042, 2448071, 4244181)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on January 24, 2009 and by e-mail on January 27, 2009. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 pool
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0942-09
CODE
Unit: 5370095
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on February 2, 2009 and by letter dated February 3, 2009. 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
CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0943-09;
b) Plasma Frozen within 24 hours (FP24). Recall # B-0944-09
CODE
a) and b) Unit: 19LT56524
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on January 16, 2009 and by facsimile on January 17, 2009. 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
TN
___________________________________
PRODUCT
Platelets Irradiated. Recall # B-0946-09
CODE
N26813, N49095, N47296, N47515, N26801, N47294, N07458, N07452, N07451, N49098, N26807, N26803, N26814, N26797, N26808, N47507, N46950, N07383, N46986, N07453, N47512, X59357
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc. Richmond, VA, by letter dated March 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not irradiated in accordance with specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0947-09
CODE
FH41307
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by facsimile on September 5, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0949-09
CODE
Units: 2476970B, 2476970A, 2512338B, 2512338
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc. Lexington, KY, by letter dated January 20, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0950-09
CODE
Unit: W053308820524
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc. Appleton, WI, by letter dated December 10, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Platelets. Recall # B-0951-09;
b) Red Blood Cells Leukocytes Reduced. Recall # B-0952-09
CODE
a) and b) 2534269
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc. Lexington, KY, by letter dated January 9, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0955-09
CODE
Unit: W041008133955Y
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. dba United Blood Services, Scottsdale, AZ, by telephone and fax on December 9, 2008.
Manufacturer: Blood Systems, Inc. dba United Blood Services, Mesa, AZ. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0956-09
CODE
Units: W045008905869 (part 1 and 2) W045008913835 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter dated December 10, 2008.
Manufacturer: Community Blood Center Of Greater Kansas City, Lawrence, KS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MO
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
a) Recovered Plasma. Recall # B-0913-09;
b) Source Leukocytes. Recall # B-0914-09
CODE
a) and b) Units: 9575372
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 30, 2008, and by electronic mail, letter and Fax on January 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Sweden, PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0931-09
CODE
Unit: W036708100839
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile and letter on November 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma, Recall # B-0945-09
CODE
Unit: 08DILG4163
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dekalb, IL, by facsimile on February 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment. Recall # Z-1195-2009
CODE
Product Number: 2121-IQ; Serial Numbers: 410614CV2, 253627INNOVA5, 808547QCV4, IE1100VA03, 713794LAB11, 936WH2121, 3108252121A, 416480INNOVA2, 3108252121B, 215576INNOVA2, 617636IN2121, 304526INNOVABP, 853060201, 541743CL5, 4105502121, 202782LABA, 857307IN32121, YV0362, YV0369, 610526LAB3, 610954BP1, 612273INNOVA3, 410614CV1, 857307IN12121, 857307IN22121, 319272EP, YV0363, 904202WCL1, 4146492121, FHORLEP4, FHORLEP5, 206598UWBP, 316268BIPLANE and HSRINNOVA1 and Product Number: 3131-IQ; Serial Numbers: 8184093131, 00440VAS04, 509474BIP, 561548BIP, 812238UNBPL, 615222BIH, 303425CL2, 516562INNOVA1, RO1095VA01, 6263973131, YV0462, YV0463, 853060198, 4144473131, BH1000VA01, 5135843131, 507385INN3131, 541382BP, YV0464, M4166990, YV0470, YV0166, 10307VAS01, 317338PV4, 309655FSP4A, YV0466, 773RES3131BP, 309655FSP2B, 713794LAB8, 630933INVLAB4, 518262BP1, 853060202, 00026VAS01, 410740CV, 834160004, 853060200, 301295EP, N4192939, COR373252, 2197383131, 718579INNOVABP, 83016900000000, 816932SL3131, 814877BP, 281637SL3131, 617525IN13131, FHORL3131, A5632421, FDO 0002769264, YV0471 and 834160005
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC. Waukesha WI, by letter dated February 2, 2009.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imaging function remains available to continue the examination, however: The images already acquired may either not be reviewable or the record of images may not be possible. This intermittent failure may result in an additional exposure to patient of X-ray sometimes with iodine (depending on Health Care Professional decision).
VOLUME OF PRODUCT IN COMMERCE
85 devices
DISTRIBUTION
Nationwide and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy
___________________________________
PRODUCT
Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. Recall # Z-1196-2009
CODE
Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Alameda, CA, by telephone beginning November 1, 2008.
Manufacturer: Benchmark Electronics, Rochester, MN. Firm initiated recall is complete.
REASON
The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, AZ
___________________________________
PRODUCT
HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment. Recall # Z-1199-2009
CODE
Serial Numbers within the range of US00442485 through US00469873. The following additional units are also affected because their energy select switches were replaced within the relevant time period: Serial Numbers: US00100353 US00110688 US00121145 US00338153 US00100741 US00110914 US00121658 US00439208 US00100843 US00111399 US00123159 US00439504 US00101080 US00112143 US00124026 US00439652 US00101500 US00112685 US00125012 US00439661 US00102492 US00114680 US00125049 US00439688 US00102580 US00114900 US00125344 US00439930 US00102583 US00116677 US00126424 US00441252 US00102601 US00116965 US00127322 US00441758 US00102643 US00117003 US00127620 US00441855 US00103225 US00118060 US00213344 US00441862 US00103916 US00118260 US00213559 US00104178 US00118602 US00230434 US00105134 US00118915 US00230588 US00106329 US00118985 US00231849 US00106922 US00119444 US00232228 US00108281 US00119624 US00232394 US00108296 US00120241 US00233505 US00109777 US00120466 US00234442 US00110403 US00120589 and US00234615
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc. Andover, MA, by letter dated March 2009. Firm initiated recall is ongoing.
REASON
Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE
26,992 units
DISTRIBUTION
Nationwide and countries of Canada, Albania, Argentina, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macau, Macedonia, Malaysia, Mali, Martinique, Mauritius, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Virgin Islands and Yemen
___________________________________
PRODUCT
a) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH FIRM 10F/25CM M001271790 FLEXIMA NEPH REG 8F/25CM M001271800 FLEXIMA NEPH REG 10F/25CM M001271810 FLEXIMA NEPH REG 12F/25CM M001271820 FLEXIMA NEPH REG 14F/25CM M001271830 FLEXIMA NEPH SOFT 10F/25CM M001271840 FLEXIMA NEPH SOFT 12F/25CM M001271850 FLEXIMA NEPH SOFT 14F/25CM M001281790 FLEXIMA NEPHROSTOMY 8/25 TT M001281800 FLEXIMA NEPHROSTOMY 10/25 TT M001281810 FLEXIMA NEPHROSTOMY 12/25 TT M001281820 FLEXIMA NEPHROSTOMY 14/25 TT M001271860 FLEXIMA NEPH 8F/25CM REG KIT M001271870 FLEXIMA NEPH 10F/25CM REG KIT M001271880 FLEXIMA NEPH 12F/25CM REG KIT M001271890 FLEXIMA NEPH 14F/25CM REG KIT M001271900 FLEXIMA NEPH 8F/25CM FIRM KIT M001271910 FLEXIMA NEPH 10F/25CM FIRM KIT M001281650 FLEXIMA NEPH 8/25 TEMP TIP KIT M001281660 FLEXIMA NEPH/10/25 TEMPTIP KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1331-2009;
b) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271240 FLEXIMA APDL FIRM 10F/25CM M001271310 FLEXIMA APDL FIRM 6.3F/25CM M001271320 FLEXIMA APDL FIRM 8F/25CM M001271330 FLEXIMA APDL REG 6.3F/25CM M001271340 FLEXIMA APDL REG 8F/25CM M001271350 FLEXIMA APDL REG 10F/25CM M001271380 FLEXIMA APDL REG 12F/25CM M001271390 FLEXIMA APDL REG 14F/25CM M001271460 FLEXIMA QUICKSTICK LL 8FR M001271470 FLEXIMA QUICKSTICK LL 10FR M001275060 APDTL/7.3FR FLEXIMA SINGLE TT M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT M001281340 FLEXIMA APDL 8/25 TT M001281350 FLEXIMA APDL 10/25 TT M001281380 FLEXIMA APDL 12/25 TT M001281390 FLEXIMA APDL 14/25 TT M001271960 FLEXIMA APDL 8FR REG KIT M001271970 FLEXIMA APDL 10FR REG KIT M001271980 FLEXIMA APDL 8FR FIRM KIT M001271990 FLEXIMA APDL 10FR FIRM KIT M001275070 APDTL/7.3FR FLEXIMA KIT TT M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE M001275090 APDLTL/7.3FR FLEXIMA KIT TT M001275030 FLEXIMA APDLTL/7/30 STAND KIT M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1332-2009;
c) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas. Recall # Z-1333-2009;
d) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001205501 SACKS SS/6FR/28CM (BX/5) M001205521 SACKS SS/8.3FR/28CM (BX/5) Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1334-2009;
e) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001221000 AA/8/30 M001221010 AA/10/30 M001221020 AA/12/30 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z1335-2009;
f) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001201050 VSKCL-12 M001201060 VSKCL-14 M001202020 VSDCL-12 M001202030 VSDCL-14 M001203060 VSCL-12 M001203070 VSCL-14 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1336-2009;
g) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001272600 FLEXIMA BILIARY REG RO 8F/35CM M001272610 FLEXIMA BILIARY REG RO 10F/35CM M001272620 FLEXIMA BILIARY REG RO 12F/35CM M001272630 FLEXIMA BILIARY REG RO 14F/35CM M001272640 FLEXIMA BILIARY FIRM RO 8F/35CM M001272650 FLEXIMA BILIARY FIRM RO 10F/35CM M001272660 FLEXIMA BILIARY SOFT RO 10F/35CM M001272670 FLEXIMA BILIARY SOFT RO 12F/35CM M001282600 FLEXIMA BILIARY TT RO 8F/35CM M001282610 FLEXIMA BILIARY TT RO 10F/35CM Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1337-2009;
h) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001245260 VTCG/8/25 M001245270 VTCG/10/25 M001245280 VTCG/12/25 M001245290 VTCG/14/25 M001245300 VTCGK/8/25 M001245310 VTCGK/10/25 M001245320 VTCGK/12/25 M001245061 APD/LPG/6/25 (BX/5) M001245071 APDL/8.3/20 (BOX/5) M001245081 APD/LPG/10/25 (BX/5) M001245130 VSCD/LPG/12/25 M001245140 VSCD/LPG/14/25 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1338-2009;
i) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001225240 VTC FIRM KIT 8 M001225140 VTC FIRM 8 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1339-2009;
j) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1340-2009;
k) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001213060 VSCTT/LOOP/12/35 M001213070 VSCTT/LOOP/14/35 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1341-2009;
l) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001221360 I/E-8/22 M001221370 I/E-8/24 M001221380 I/E-8/26 M001221390 I/E-8/28 M001221400 I/E-10/22 M001221410 I/E-10/24 M001221420 I/E-10/26 M001221430 I/E-10/28 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1342-2009;
m) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001231360 IE TEMP TIP 8/22 M001231370 IE TEMP TIP 8/24 M001231380 IE TEMP TIP 8/26 M001231390 IE TEMP TIP 8/28 M001231400 IE TEMP TIP 10/22 M001231410 IE TEMP TIP 10/24 M001231420 IE TEMP TIP 10/26 M001231430 IE TEMP TIP 10/28 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1343-2009;
n) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064102020 Percuflex All Purpose Drainage Catheters wit Fader Tip and Locking Pigtail 8 Fr M0064102030 Percuflex All Purpose Drainage Catheters with Fader Tip and Locking Pigtail 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1344-2009;
o) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN # Description M0064102040 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 8 Fr M0064102050 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 10 Fr M0064102060 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 12 Fr M0064103040 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip (Kit) 8 Fr M0064103050 Percuflex Locking Loop Nephrostomy Cateters with Fader Tip (Kit) 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1345-2009;
p) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064101110 Percutaneous Nephrostomy Catheters Percutaneous with Locking Loop 8 Fr M0064101120 Nephrostomy Catheters with Locking Loop 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1346-2009;
q) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr Single Use Only, Sterilized with Ethylene Oxide Gas, Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1347-2009
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp. Maple Grove, MN, by letter dated March 18, 2009.
Manufacturer: Boston Scientific Corp. Spencer, IN. Firm initiated recall is ongoing.
REASON
Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
VOLUME OF PRODUCT IN COMMERCE
586,276 Nationwide; 276,013 Internationally
DISTRIBUTION
Nationwide, including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela
___________________________________
PRODUCT
a) Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Standard as follows: v.8.04.02.10, catalog no. 04785550001; v.8.04.03, catalog no. 04785550002; and v.8.06.02, catalog no. 05108993001. The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.. Recall # Z-1393-2009;
b) Roche cobas 6000 analyzer series (cobas c 501 and cobas e 601) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001. The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems. Recall # Z-1394-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp. Indianapolis, IN, by letter dated April 1, 2009.
Manufacturer: Data Innovations, Inc. South Burlington, VT. Firm initiated recall is ongoing.
REASON
Some data alarm flags do not transfer from the analyze to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.
VOLUME OF PRODUCT IN COMMERCE
498 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000. Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus. Recall # Z-1395-2009
CODE
CDM version 4.0 software
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc. Hercules, CA, by telephone, fax and letter on December 10, 2008. Firm initiated recall is ongoing.
REASON
The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Thailand, and the UK
___________________________________
PRODUCT
Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus Recall # Z-1400-2009
CODE
Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31; Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc. Lenexa, KS, by letter dated November 20, 2008, by telephone beginning December 30, 2008 to January 11, 2009 and by letters dated March 16, 2009.
Manufacturer: Remel Europe Ltd. Dartford, England. Firm initiated recall is ongoing.
REASON
The lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
446 kits
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children. Recall # Z-1408-2009;
b) In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes' Rapid Resorbable Fixation System this is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children. Recall # Z-1409-2009
CODE
a) Lot numbers TM00119 exp 6/30/05, TM00122 exp 7/31/04, TM00124 exp 7/31/04, TM00128 exp 9/30/05, TM00150 exp 10/31/06, TM00155 exp 3/9/07, TM00160 exp 12/29/08, TM00172 exp 3/30/09, TM00197 exp 7/31/09, TM00220 exp 9/7/09, TM00221 exp 9/7/09, TM00260 exp 3/10/10, TM00271 exp 4/28/10, TM00295 exp 10/10/10, TM00315 exp 2/28/11, TM00322 exp 4/13/11, 4859489 exp 7/30/05, 4859490 exp 6/30/05, 4859492 exp 7/31/05, and TM00341 exp 3/12/12;
b) Lot numbers: TM00051 exp 9/24/02, TM00072 exp 03, TM00098 exp 1/31/05, TM00151 exp 10/31/05, TM00156 exp 3/9/07, TM00161 exp 12/29/07, TM00173 exp 3/30/08, TM00192 exp 5/30/08, TM00340 exp 1/3/11, TM00261 exp 3/10/09, TM00280 exp 7/31/09, TM00300 exp 10/10/09, TM00316 exp 2/27/10, TM00324 exp 4/8/10, and 4691525 exp 1/31/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes Spine, West Chester, PA, by letter on April 6, 2009.
Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.
REASON
Sterility may be compromised due to a ineffective package design.
VOLUME OF PRODUCT IN COMMERCE
2,706 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement. Recall # Z-1410-2009
CODE
Lot # 211080002; Lot # 22109602; Lot # 21883201; Lot # 21910302 and 21883401
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on April 2, 2009.
Manufacturer: Stryker Ireland, LTD, Orthopedics, Carrigtohill, Ireland. Firm initiated recall is ongoing.
REASON
Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR MAY 27, 2009
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