May 28, 2003
03-22
_______________________________
PRODUCT
Ricotta Salata, Pasta Stuffing Cheese, Made from 100 % pure sheeps milk, cultures, rennet, salt. Imported from Italy. Pressed cooked cheese. Product was distributed in bulk and in pre-cut pieces. Recall # F-369-3.
CODE
Bulk product code - PD 5/23/02. Pre-cut - sell by dates from January 4, 2003 through February 20, 2003.
RECALLING FIRM/MANUFACTURER
Schratter Foods, Inc., Fairfield, NJ, by letters on November 26, 2002, press release on November 27, 2002, fax notifications followed by telephone calls. State initiated recall is ongoing.
REASON
Ricotta Salata Cheese was found to be contaminated with Listeria monocytogenes by the Georgia Department of Agriculture.
VOLUME OF PRODUCT IN COMMERCE
6,702 pounds.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Easy Bake "N Design Cookie Sets containing pink and blue FooDoodler markers. Recall # F-370-3;
b) Easy Bake "N Design Cookie Sets containing red and yellow FooDoodler markers. Recall # F-371-3.
CODE
a) Product number: 60813/60821;
b) Product number: 60814/60821.
RECALLING FIRM/MANUFACTURER
Hasbro, Inc., Pawtucket, RI, by press release and telephone on April 10, 2003, and by letter on April 11, 2003. Firm initiated recall is ongoing.
REASON
White cookie mix packet contains undeclared nonfat dried milk.
VOLUME OF PRODUCT IN COMMERCE
Approx. 155,000 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Ashdon Farms Chocolate Covered Raisins, Net WT. 7 oz.,
packed in plastic bags;
b) Girl Scouts Chocolate Covered Raisins, Net Wt., 12 oz.,
packed in cans. Recall # F-375-3.
CODE
a) Production code "2305A6";
b) Production code "2283A10".
RECALLING FIRM/MANUFACTURER
Ashdon Farms, Waukesha, WI, by telephone on November 15 and 16, 2002, and by faxed letter, dated November 19, 2002. Firm initiated recall is ongoing.
REASON
Product labeled as "Chocolate covered Raisins" actually contains a mixture of chocolate covered raisins and chocolate covered peanuts.
VOLUME OF PRODUCT IN COMMERCE
a) 133 cases of 24/7 oz. per case;
b) 98 cases of 12/12 oz per case.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Western Guacamole, frozen; 12/1 lb. plastic tubs per case; Product of Mexico; product number 000259-7692197. Recall # F-377-3.
CODE
Lot 2266.
RECALLING FIRM/MANUFACTURER
AvoCo International LLC, Rosemont, IL, by faxed letter on April 2, 2003. FDA initiated recall is ongoing.
REASON
The product was contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
463 cases.
DISTRIBUTION
NJ, MA, VA, CT, NY, and PA.
_______________________________
PRODUCT
a) A liquid product labeled only on the cap as "100% Fresh Lime Juice
Packed by Florida Citrus Made in USA." The reconstituted mix was
Placed in one gallon plastic jugs with no ingredient statement.
Recall # F-378-3.
b) A liquid product labeled only on the cap as "100% Fresh Lemon
Juice. Packed by Florida Citrus Made in USA." The reconstituted
mix was Placed in one gallon plastic jugs with no ingredient
statement. Recall # F-379-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Florida Citrus Juice Company, Tampa, FL, by telephone on March 26, 2003, and by faxed letter on April 1, 2003. FDA initiated recall is ongoing.
REASON
The product, misbranded as 100% juice, fails to list dry egg whites as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
50 gallons.
DISTRIBUTION
FL, and GA.
_______________________________
PRODUCT
Winter Melon Candy, Net Wt.; 12 oz. (340 g), packaged in a flexible plastic bag, Ing: plum, salt, sugar. PRODUCT OF TAIWAN.
Recall # F-380-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Sunny Lake Trading, Inc., Brooklyn, NY, by press release on December 3, 2002, and by letters dated December 3, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites (2394 ppm).
VOLUME OF PRODUCT IN COMMERCE
26 cases (50 packages per case).
DISTRIBUTION
NY.
_______________________________
PRODUCT
a) Sau-Sea(R) Lobster SPREAD, KEEP REFRIGERATED,
NET WT. 7.5 OZ (212 g), packaged in a plastic tub with
lid. Recall # F-385-3;
b) Sau-Sea(R) Shrimp SPREAD with Roasted Garlic, KEEP
REFRIGERATED, NET WT. 7.5 OZ (212 g), packaged in a plastic tub
with lid. Recall # F-386-3;
c) Sau-Sea(R) Crab SPREAD with Jalapeno, KEEP REFRIGERATED,
NET WT. 7.5 OZ (212g), packaged in a plastic tub with lid.
Recall # F-387-3.
Products were packaged in a rigid plastic containers with a use by
date imprinted on the containers (see codes). There are 12 - 8 oz.
containers per case.
CODE
a) Item # 08066; "Use by Date": 7/25/02, 8/10/02, 9/05/02, 9/20/02;
b) Item # 08067; "Use by Date": 7/25/02, 8/10/02, 8/29/02, 9/20/02;
c) Item # 08064; "Use by Date": 7/25/02, 8/10/02, 8/22/02, 9/05/02,
9/20/02.
NOTE: the spreads have a shelf life that is equal to 60 days from
the date of production.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sau-Sea Foods, Inc, Tarrytown, NY, by memos on
July 8, 2002, July 12, 2002, and July 15, 2002, and by follow-up memos on July 31, 2002.
Manufacturer: Zebu Enterprises, LLC Shrewsbury, NJ. FDA initiated recall is complete.
REASON
Seafood spreads contain undeclared ingredients including egg white and wheat gluten.
VOLUME OF PRODUCT IN COMMERCE
a) 462 cs (12 - 7.5 oz. units/case);
b) 420 cs (12 - 7.5 oz. units/case);
c) 299 cs (12 - 7.5 oz. units/case).
DISTRIBUTION
NY, IL, GA, and OH.
_______________________________
PRODUCT
Cold-smoked salmon pieces (trimmings) in unlabeled clear plastic vacuum packages. Product is stored frozen, packaged in 2-3 lbs. each. Recall # F-333-3.
CODE
The firm identified the following date codes: 10-16, 10-28, 10-29, 11-4, and 11-7.
RECALLING FIRM/MANUFACTURER
Scandinavian Smoke House, Inc, San Francisco, CA, via telephone and letter on November 12, 2002. FDA initiated recall is complete.
REASON
Brine reports were not available during the processing of salmon pieces resulting in the potential for the formation of C. botulinum toxin.
VOLUME OF PRODUCT IN COMMERCE
233 pieces.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Candy products including fudge, jellies, chocolates, taffies, and brittles. Recall # F-359-3.
CODE
All codes that do not contain an ingredient statement. The firm utilizes a lettering system to designate the month of manufacture and best by month. Each type of product utilizes a different lettering system.
RECALLING FIRM/MANUFACTURER
Cranberry Sweets Co., Inc, Coos Bay, OR, by telephone on March 21, 2003. FDA initiated recall is complete.
REASON
The products do not bear ingredients statements and may contain allergens such as eggs, milk, tree nuts, peanuts, and soy.
VOLUME OF PRODUCT IN COMMERCE
230 varieties of candies.
DISTRIBUTION
OR.
_______________________________
PRODUCT
Ancom Tablets (Anti-Hypertensive Compound Tablets), 100 count bottles, Manufactured by SHANGHAI PHARMACEUTICALS INDUSTRY CORP. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as - Ancom Tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6 1 mg. The bottle, unit carton & insert are labeled both in English and Chinese. Recall # D-260-3.
CODE
All lots
RECALLING FIRM/MANUFACTURER
Tai Chien, Inc., New York, NY, by press release and recall letter on March 17, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug containing prescription ingredients
VOLUME OF PRODUCT IN COMMERCE
1,850 units.
DISTRIBUTION
NY and Puerto Rico.
_______________________________
PRODUCT
Sarapin Injection, Pitcher Plant, 50 ml Multiple Dose Vial, Sterile aqueous solution of soluble salts of the volatile bases. Recall # D-249-3.
CODE
Lot number - 205722 (Exp. Date 05/2005);
Lot number - 205825 (Exp. Date 05/2005);
Lot number - 206824 (Exp. Date 06/2005).
RECALLING FIRM/MANUFACTURER
High Chemical Co, Levittown, PA, by letters on April 4, 2003. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility (by manufacturer-Akorn, Inc.)
VOLUME OF PRODUCT IN COMMERCE
38,571 vials.
DISTRIBUTION
Nationwide, Canada, Switzerland, Bulgaria, and the Netherlands.
_______________________________
PRODUCT
Lioresal Intrathecal Refill Kits, Model 8562, (baclofen injection), 10mg/5mL (2000 mcg/mL), 2-5 mL ampules per kit, refill kit/drug prep kit, Rx only. Recall # D-258-3.
CODE
Lot number B03001710N, Exp. Date 03 Feb 05.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc, Minneapolis, MN, by telephone on April 23, 2003. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility - cracks in refill kit tray (gloves, needles, filter, etc., not drug or drug prep kit).
VOLUME OF PRODUCT IN COMMERCE
68 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Erythromycin, USP Base, Dihydrate, Code No. 79147, bulk drug (drum), Caution: For Manufacturing, Processing or Repacking, Rx Only. Recall # D-250-3.
CODE
Lot 72332CD00, Exp.12/13/05.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, North Chicago, IL, by letter on April 25, 2003. Firm initiated recall is ongoing.
REASON
Failure of x-ray identification limit for monohydrate form.
VOLUME OF PRODUCT IN COMMERCE
Portion of one lot to a single manufacturer
DISTRIBUTION
NY.
_______________________________
PRODUCT
a) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
2.5 mg/6.25mg, bottles of 100, Rx only. Recall # D-255-3;
b) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
5 mg/6.25mg, bottles of 100, Rx only. Recall # D-256-3;
c) Bisoprolol Fumarate and Hydrochlorothiazide Tablets,
10mg/6.25mg. bottles of 30, Rx only. Recall # D-257-3.
CODE
a) Lot No. 306M11 Exp Date 1/03; 460F21 Exp Date 10/03;
481C11 Exp Date 9/03; 575H11 Exp Date 5/03;
576H11 Exp Date 5/03; 870D21 Exp Date 5/03;
871D21 Exp Date 11/03; 872D21 Exp Date 11/03;
966E11 Exp Date 6/03; 967E11 Exp Date 6/03;
b) Lot No. 307M11 Exp Date 1/04; 308M11 Exp Date 1/04;
309M11 Exp Date 1/04; 361B11 Exp Date 3/03;
362B11 Exp Date 3/03; 482C11 Exp Date 3/03;
483C11 Exp Date 3/03; 577H11 Exp Date 10/03;
578H11 Exp Date 10/03; 873D21 Exp Date 5/04;
874D21 Exp Date 5/04; 875D21 Exp Date 5/04;
876D21 Exp Date 5/04; 968E11 Exp Date 6/03;
969E11 Exp Date 8/03;
c) Lot No. 310M11 Exp. Date 1/04; 363B11 Exp. Date 3/03;
579H11 Exp. Date 9/03; 580H11 Exp. Date 9/03;
877D21 Exp. Date 5/04; 878D21 Exp. Date 5/04;
879D21 Exp. Date 5/04; 970E11 Exp. Date 6/03.
RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter dated March 20, 2003 and sent via certified mail on March 21, 2003. Firm initiated recall is ongoing.
REASON
Impurity failure; product failed to meet the Bisoprolol Fumarate unknown impurity specification.
VOLUME OF PRODUCT IN COMMERCE
756,230 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0909-3;
b) Cryoprecipitated AHF. Recall # B-0910-3;
c) Recovered Plasma. Recall # B-0911-3.
CODE
a), b), and c) Unit number 50H93583.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by letter and facsimile on August 29, 2002, and December 30, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH, and Switzerland.
_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-0987-3;
b) Recovered Plasma. Recall # B-0988-3.
CODE
a) and b) Unit 21GY79013.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on February 7, 2002, and by letter dated February 19, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to Red Blood Cells that showed evidence of air contamination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0989-3.
CODE
Unit 5421504.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 12, 2001, and by letter dated December 7, 2001. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0997-3;
b) Plasma. Recall # B0998-3.
CODE
a), and b) Unit number 0369085.
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by letter and facsimile on June 25, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous self-exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-0999-3.
CODE
Unit number 0892003.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated December 2, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a decreased hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1000-3;
b) Platelets, Leukocytes Reduced. Recall # B-1001-3.
CODE
a) and b) Unit number 0872313.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated December 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and KY.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1002-3.
CODE
Unit number 0828877.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated October 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
________________________
PRODUCT
Red Blood Cells. Recall # B-1003-3;
Platelets. Recall # B-1004-3.
CODE
a) and b) unit number 7567431.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 27, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1005-3;
Cryoprecipitated AHF. Recall # B-1006-3;
Plasma, Cryoprecipitate Reduced. Recall # B-1007-3.
CODE
a), b), and c ) Unit number 5294074.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 22, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Platelets. Recall # B-1008-3.
CODE
Unit number 5293879.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1010-3;
b) Platelets. Recall # B-1011-3;
c) Fresh Frozen Plasma. Recall # B-1012-3.
CODE
a), b), and c) Unit number 7544446.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated July 3, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose body temperature was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1013-3;
b) Fresh Frozen Plasma. Recall # B-1014-3.
CODE
a) and b) Unit 7445273.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 18, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received the MMR vaccine within 2 weeks of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-1021-3;
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1022-3.
CODE
a) and b) Unit number 7567283.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated March 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1023-3.
CODE
Unit number 0180199.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 24, 2002, and by letter dated May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1025-3;
Platelets. Recall # B-1026-3.
CODE
a) Unit numbers 5352685, 7727575, and 7696671;
b) Unit number 5352685.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 21, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-1027-3;
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1028-3.
CODE
a) Unit numbers 7579961, 7579742, 7579586, 7578589, 7578369, 7578112,
7577931, 7577767, 7576909, 7576740, and 7576499, and the following
unit was distributed as two split products: unit number 7577505.
b) Unit number 7579360.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 18, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 13 units;
b) 1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1029-3.
CODE
Unit number 7896204.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on December 5, 2001, and by letter dated December 20, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1033-3;
b) Recovered Plasma. Recall # B-1034-3.
CODE
a) and b) Unit numbers 12LJ32126 and 12LS52686.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letters on December 9, 2002, and January 7, and 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a previous positive test for hepatitis and jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC, CA, and Switzerland.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1035-3.
CODE
Unit number 5280714.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Red Blood Cells. Recall # B-1040-3;
b) Fresh Frozen Plasma. Recall # B-1041-3.
CODE
a) and b) Unit number 7427886.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous reactive viral marker testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Carticel (Autologous Cultured Chondrocytes). Recall # B-1042-3.
CODE
Lot number CC07818.
RECALLING FIRM/MANUFACTURER
Genzyme Tissue Repair, Cambridge, MA, by telephone on September 25, 2002. Firm initiated recall is complete.
REASON
Autologous product from a different individual was distributed with labeling that incorrectly identified the intended recipient.
VOLUME OF PRODUCT IN COMMERCE
1 lot.
DISTRIBUTION
GA.
________________________________
PRODUCT
Corneas. Recall #B-1045-3.
CODE
ID numbers 2002-05-3291, 2002-05-3292.
RECALLING FIRM/MANUFACTURER
Central Florida Lions Eye and Tissue Bank, Tampa, FL, by letter dated April 18, 2003. Firm initiated recall is complete.
REASON
Corneas that were collected from donors who were found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
WI, FL, Egypt, Mexico, Guatemala, and Singapore.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1052-3.
CODE
Unit number 17198-3460.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone and by letter dated March 30, 2002. Firm initiated recall is complete.
REASON
Blood products, collected by automated equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1053-3.
CODE
Unit number 71E17879-0.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile dated October 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1060-3.
CODE
Unit number 7836820.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated August 28, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1061-3.
CODE
Unit number 8395025.
RECALLING FIRM/MANUFACTURER
South Florida Blood Banks, Inc., West Palm Beach, FL, by telephone on February 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a decreased hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1062-3.
CODE
Unit number 71W22217-5.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by telephone on October 4, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1063-3.
CODE
Unit number 17200-5229.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on February 6, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-1064-3.
CODE
Unit number WSN001430.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc, Houston, TX, by facsimile on January 27, 2002. Firm initiated recall is complete.
REASON
Blood product tested negative for viral markers but was collected from an ineligible donor due to risk factors for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0907-3.
CODE
Unit number 16361-5068 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 24, 2001, and by letter on October 25, 2001.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.
_______________________________
PRODUCT
Platelets. Recall # B-0990-3.
CODE
Unit 5410357.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 7, 2002. Firm initiated recall is complete.
REASON
Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
a) Platelets. Recall # B-0991-3;
b) Fresh Frozen Plasma. Recall # B-0992-3.
CODE
a) and b) Unit number 5459713.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 20, 2002, and by letter dated May 7, 2002. Firm initiated recall is complete.
REASON
Blood products, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Platelets. Recall # B-0993-3;
b) Fresh Frozen Plasma. Recall # B-0994-3.
CODE
a) and b) Unit 5417303.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 9, 2002. Firm initiated recall is complete.
REASON
Blood products, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells. Recall #B-0995-3.
CODE
Units 5292920 (split unit).
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_____________________________________
PRODUCT
Red Blood Cells. Recall # B-0996-3.
CODE
Unit number 20404-1793.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 17, 2001.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1009-3.
CODE
Unit number 5293829.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Recovered Plasma. Recall # B-1024-3.
CODE
Unit number 0180199.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 24, 2002, and by letter dated May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX, and Switzerland.
________________________________
PRODUCT
Corneas. Recall # B-1046-3.
CODE
ID numbers 2002-06-3375, 2002-06-3376, 2002-06-3501, 2002-06-3502, 2002-06-3505, 2002-06-3506.
RECALLING FIRM/MANUFACTURER
Central Florida Lions Eye and Tissue Bank, Tampa, FL, by letter dated April 18, 2003. Firm initiated recall is complete.
REASON
Corneas that were collected from donors who were found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
6 tissues.
DISTRIBUTION
WI, FL, Egypt, Mexico, Guatemala, and Singapore.
________________________
PRODUCT
Misys Laboratory System. Recall # Z-0791-03.
CODE
Versions 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on March 26, 2003. Firm initiated
recall is ongoing.
REASON
With SMART enabled, for an accession number with multiple tests, credits and
additions, the system may delete and reorder resulted tests.
VOLUME OF PRODUCT IN COMMERCE
463.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9
Software Version. Recall # Z-0792-03;
b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9
Software Version. Recall # Z-0793-03;
c) Gemstar_ Therapy Pain Management I.V. Infusion Pump,
List#: 13150-04; 2.9 Software Version. Recall # Z-0794-03;
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Morgan Hill, CA, by letters on April 1, 2003. Firm initiated
recall is ongoing.
REASON
Products contain software deficiencies which could allow over infusion thereby
administering excess medication.
VOLUME OF PRODUCT IN COMMERCE
1,310 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Vacuette Safety Blood Collection Set with Luer Adapter. Recall # Z-0797-03.
CODE
Item number 450096, Lot #'s 02109C, 02111C, and 02120C.
RECALLING FIRM/MANUFACTURER
Greiner VACUETTE North America, Monroe, NC, by letter on/about March 6, 2003.
Firm initiated recall is ongoing.
REASON
The needle portion of the Safety Blood Collection Sets, may become separated
from the body of the Luer Adapter.
VOLUME OF PRODUCT IN COMMERCE
139,000 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01
and 21-1713-01. The 3 versions vary only in the color of the exterior. Recall
# Z-0798-03.
CODE
All units distributed since product introduction in December 2002 are involved.
RECALLING FIRM/MANUFACTURER
Deltec, Inc., St Paul, MN, by letters on March 14, 2003. Firm initiated recall
is ongoing.
REASON
A software error can result in the delivery of a larger bolus of insulin than
anticipated when the pump is programmed in a particular manner.
VOLUME OF PRODUCT IN COMMERCE
913 pumps.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Anti-HBs Reagent Kit, 100 tests. Recall # Z-0801-03.
CODE
List 7C18-25, lot 95305M200.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter on April 7, 2003. Firm
initiated recall is ongoing.
REASON
Particulate matter in the microparticle component.
VOLUME OF PRODUCT IN COMMERCE
289 kits.
DISTRIBUTION
Canada, Germany and Japan.
______________________________
PRODUCT
Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12
suture needles per glass vial; part code: SN4. Recall # Z-0802-03.
CODE
All units distributed between 1/3/01 and 3/10/03.
RECALLING FIRM/MANUFACTURER
Hu-Friedy Mfg., Co., Inc, Chicago, IL, by letters dated April 10, 2003. Firm
initiated recall is ongoing.
REASON
The suture needles were mislabeled with the wrong size.
VOLUME OF PRODUCT IN COMMERCE
200 vials.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Misys Laboratory System. Recall # Z-0804-03.
CODE
Versions 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on March 27, 2003. Firm initiated
recall is ongoing.
REASON
Software anomaly may result in incorrect values and interpretations.
VOLUME OF PRODUCT IN COMMERCE
463.
DISTRIBUTION
Nationwide, and Internationally.
_____________________________
PRODUCT
Twister (tm) Cube Back-Cane Short, a wheelchair back seat support strap, part
number WPHS. Recall # Z-0812-03.
CODE
Lots IA702, II327, IK454, and IM236.
RECALLING FIRM/MANUFACTURER
Action Products Incorporated, Hagerstown, MD, by letter on February 25, 2003.
Firm initiated recall is ongoing.
REASON
Stitching in wheelchair seat back is not effective and may not support user.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) CoaguChek Pro DM meter; catalog # 1894048, and 1893211.
Recall # Z-0813-03;
b) CoaguChek Plus meter; catalog # 4757298, and 12816001.
Recall # Z-0814-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated March 12, 2003.
Firm initiated recall is ongoing.
REASON
High frequency signals from other medical or communications equipment will result
in a variable positive bias in test results.
VOLUME OF PRODUCT IN COMMERCE
1,794.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U,
FRM61750. Recall # Z-0815-03.
CODE
All frames manufactured since the product was released are suspect.
RECALLING FIRM/MANUFACTURER
Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March
17, 2003. Firm initiated recall is ongoing.
REASON
Knee frame defect led to breakage and injury. Knee bolt end came loose.
VOLUME OF PRODUCT IN COMMERCE
261.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages.
Each package contains one Dr. Fog treated sponge. Recall # Z-0828-03.
CODE
Lot 2005-02-17. Exp. February 2005.
RECALLING FIRM/MANUFACTURER
Aspen Surgical Products, Inc., Bryon Center, MI, by telephone on April 30, 2003.
Firm initiated recall is ongoing.
REASON
Sterility compromised - incomplete sterile package seal.
VOLUME OF PRODUCT IN COMMERCE
299 boxes.
DISTRIBUTION
Nationwide, Japan and United Kingdom.
_____________________________
PRODUCT
a) C1141 Flexible Endoscope Processing Container, Designed to
fit the Steris System I Processor. The unit may be sold
individually or with the processing tray assembly (C1140).
Recall # Z-0829-03.
b) C1140 Flexible Endoscope Processing Container and Tray
assembly. Recall # Z-0830-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Steris Corp., Mentor, OH, by telephone and letter on April 23, 2003. Firm initiated
recall is ongoing.
REASON
The container flow port is inverted, which restricts the flow of sterilant to
the endoscope and affects the sterilization process.
VOLUME OF PRODUCT IN COMMERCE
492 units.
DISTRIBUTION
Nationwide, and Internationally.
_____________________________
PRODUCT
MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24
Fr. Recall # Z-0831-03.
CODE
Catalog No. 8908. Lot Number: 5248945.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on April 29, 2003. Firm
initiated recall is ongoing.
REASON
Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr.
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
CA, FL, MA, ME, MI, NC, PA, and WV.
_____________________________
PRODUCT
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000;
all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter
Tina and Baxter Aurora. Recall # Z-0833-03.
CODE
Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters on March 20, 2003. Firm
initiated recall is ongoing.
REASON
The dialysis treatment may be run without the bicarbonate due to an undetected
bicarbonate pump stall following a sodium change.
VOLUME OF PRODUCT IN COMMERCE
25,014 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Permobil Chairman 2K powered wheelchair. Recall # Z-0834-03.
CODE
Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.
RECALLING FIRM/MANUFACTURER
Permobile, Inc., Lebanon, TN, by letter, on March 7, 2003. Firm initiated recall
is ongoing.
REASON
One of the wheelchair motors needed a grounding strap to ensure that the motors
are at the same voltage potential as the chassis of the wheelchair.
VOLUME OF PRODUCT IN COMMERCE
1,319.
DISTRIBUTION
Nationwide, Canada, and Puerto Rico.
_____________________________
PRODUCT
SHPI LiftLoc Safety Infusion Sets. Recall # Z-0837-03.
CODE
Product Code - Lot #: 0661934- 36ANHP01; 0662034 - 36ANHP02;
0662234 - 36ANHO03; 0661910 -36ANHP04; 0661915 - 36ANHP04;
0661915 -36ANHP06; 0662015 - 36ANHO7; 0662215 -36ANHP08;
0662010- 36ANHP09; 0641910 -36ANHP10; 0642234 -36ANHP11;
0642210 - 36ANHP12; 0641934 -36ANHP13; 0642034 -36ANHP14;
0642010 -36ANHP15; 0614915 -36ANHP16; 0642015 -36ANHP17;
0642210 -36ANHP19; 0642234 -36ANHP20; 0641910 -36ANHP21.
RECALLING FIRM/MANUFACTURER
Specialized Health Products, Inc, Bountiful, UT, by letter on April 14, 2003.
Firm initiated recall is ongoing.
REASON
Pouch seals on Safety Infusion Sets may be defective, possibly compromising
sterility.
VOLUME OF PRODUCT IN COMMERCE
29,120 units.
DISTRIBUTION
UT.
______________________________
PRODUCT
a) 3M Ioban 2 Antimicrobial Incise Drapes. Recall # Z-0838-03;
b) 3M Ioban 2 Antimicrobial Incise Drapes. Recall # Z-0839-03.
CODE
a) Model 6648EZ, which were contained in Cardinal Health Custom
Procedure Packs sterilized between December 20, 2002 and
February 28, 2003, were recalled.
b) Model 6651EZ, which were contained in Cardinal Health Custom
Procedure Packs sterilized between December 20, 2002 and
February 28, 2003, were recalled.
RECALLING FIRM/MANUFACTURER
3m Health Care, Saint Paul, MN, by letter dated April 7, 2003.
Firm initiated recall is ongoing.
REASON
The product does not meet its specifications for iodine content, and has the
possibility of causing moderate short-term skin irritation if used.
VOLUME OF PRODUCT IN COMMERCE
8,702 drapes.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Leonardo MM-WS systems. System, Image Processing.
Recall # Z-0841-03;
b) Smatom Sensation 16, Computed Tomography System, Diagnostic
Imaging. Recall # Z-0842-03.
CODE
a) Model Number 7129534;
b) Model Number 7393114.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA. Update instructions on the
new software were sent on August 2, 2002 by mail. Firm initiated recall is complete.
REASON
Perfusion CT is displaying a higher gray and color values than normal. A software
problem.
VOLUME OF PRODUCT IN COMMERCE
3.
DISTRIBUTION
OH, MA, and MO.
______________________________
PRODUCT
a) ARCHITECT I System External Waste Pump. Recall Z-0795-03;
b) AEROSET System External Waste Pump. Recall # Z-0796-03.
CODE
a) Product List Number 8C94-99, no lot numbers or codes;
b) Product List Number 9D61-01, no lot numbers or codes.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on January 27, 2003. Firm initiated
recall is ongoing.
REASON
External waste pump has metal edge around perimeter sharp enough to cause scratch
or cut.
VOLUME OF PRODUCT IN COMMERCE
1,779 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
a) Z2 Guiding Catheter 6 F JL3.5 SH Item No.: Z26JL35SH.
Recall # Z-0799-03;
b) Z2 Guiding Catheter 6 F JR3.5 SH Item No.: Z26JR35SH.
Recall # Z-0800-03.
CODE
a) and b) Lot Number: 122596.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc, Danvers, MA, by e-mail on March 17, 2003. Firm initiated recall
is ongoing.
REASON
The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right)
of the catheter may not correctly match the box label.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide, Japan, and Hungary.
________________________________
PRODUCT
Aeroset Direct HDL Reagent, LN 7D67-01. Recall # Z-0803-03.
CODE
Lot 86027HW00, Exp. Date May 14, 2003;
Lot 89150HW00, Exp. Date September 13, 2003.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letters on March 28, 2003. Firm initiated recall is ongoing.
REASON
Degradation prior to expiry date.
VOLUME OF PRODUCT IN COMMERCE
1409
DISTRIBUTION
Nationwide, and Internationally.
________________________________
PRODUCT
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03.
CODE
All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on March 28, 2003. Firm initiated recall is ongoing.
REASON
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
VOLUME OF PRODUCT IN COMMERCE
98.
DISTRIBUTION
Nationwide and Canada.
________________________________
PRODUCT
Misys Commercial Laboratory, Laboratory Information System.
Recall # Z-806-03.
CODE
Version 3.4.1.
RECALLING FIRM/MANUFACTURER
Misys Healthcare System, Plano, TX, by letter on March 13, 2003. Firm initiated recall is complete.
REASON
Software logic error. Dates were printing incorrectly on cumulative reports.
VOLUME OF PRODUCT IN COMMERCE
1.
DISTRIBUTION
SC.
________________________________
PRODUCT
Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2. The product is packaged and distributed as 15 and 30 packs. Recall # Z-0827-03.
CODE
Focus Dailies Toric 15 lens pack (Cylinder 10.75/Axis 90вк): Sphere -1.00, Lot 2298508; Sphere 1.25, Lot #2298512, 2304513; Sphere -1.50, Lot #2298509, 2304510; Sphere -1.75, Lot #2304512, 2304522 and Sphere -2.00, Lot #2298510.
Focus Dailies Toric 30 lens pack (Cylinder -0.75/Axis 90вк):
Sphere -1.00, Lot #2298475, 2295481, 2298497, 2304509, 2304519, 2304529; Sphere -1.25, Lot #2298480, 2298485, 2298502, 2304523, 2304533; Sphere -1.50, Lot #2298476, 2298482, 2298498, 2304520, 2304530; Sphere -1.75, Lot #2298479, 2298484, 2298501, 2298511, 2304532 and Sphere -2.00, Lot #2298478, 2298483, 2298499, 2304511, 2304521, 2304531.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on May 6, 2003. Firm initiated recall is ongoing.
REASON
Lenses may be labeled with the incorrect axis.
VOLUME OF PRODUCT IN COMMERCE
8,572 packs (181,440 lenses).
DISTRIBUTION
Nationwide, Canada, and Europe.
________________________________
PRODUCT
BD First PICC 3F 65 cm Single Lumen Procedure Kit.
Recall # Z--0832-03.
CODE
Reference No. 384134, Lot No. 2326770.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and fax on April 4, 2003. Firm initiated recall is ongoing.
REASON
A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
VOLUME OF PRODUCT IN COMMERCE
840 kits.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Recall # Z-0835-03.
b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
Recall # Z-0836-03.
CODE
a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 8008 through 8069.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Highland Heights, OH, by a "Product Safety Notification", dated April 2, 2003. Firm initiated recall is ongoing.
REASON
Patient images may be stored in the archive directory of a different patient.
VOLUME OF PRODUCT IN COMMERCE
a) 137 units;
b) 50 units.
DISTRIBUTION
Nationwide and Internationally.
________________________________
PRODUCT
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Recall # Z-0840-03.
CODE
Serial Numbers: 1017; 1030; 1052; 1053; 1054; 1063; 1066; 1085; 1086; 1052; 1060; 1085; 1088; 1090; 1091; 1093; 1096; 1099; 1100; 1101; 1102; 1104; 1105; 1106; 1109; 1114; 1116; 1119; 1126; 1127; 1133; 1134; 1135; 1136; 1137; 1138; 1139; 1145; 1148; 1149; 1150; 1151; 1152; 1153; 1154; 1155; 1156; 1161; 1165; 1168; 1171; 1172; 1173; 1174; 1177; 1186; 1187; 1189; 1246; 1262; 1265; 1266; 1268; 1271; 1274; 1275; 1293; 1294; 1295; 1296; 1297; 1300; 1301; 1309; 1310; 1318; 1323; 1324; 1326; 1328; 1333; 1336; 1341; 1343; 1344; 1346; 1347; 1356; 1366; 1367; 1368; 1369; 1373; 1374; 1375; 1376; 1377; 1381; 1382; 1383; 1384; 1385; 1386; 1387; 1388; 1390; 1391; 1395; 1396; 1399; 1402; 1406; 1410; 1427; 1428; 1441; 1442; 1445; 1452; 1453; 1454; 1455; 1456; 1457; 1458; 1459; 1460; 1461; 1462; 1464; 1467; 1468; 1470; 1471; 1472; 1481; 1485; 1497; 4109; 4111; 4138; Govt. accounts: 1031; 1057; 1062; 1098; 1108; 1162; 1167; 1169; 1254; 1255; 1303; 1320; 1404; 1429; 1478; 1488; 1592; 1730.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on July 3, 2002. Firm initiated recall is complete.
REASON
Potential error can occur with the 3D post processing options MPR, MIP, and VRT. If a very large series are loaded into the 3D application, the scan range is not displayed entirely in the reconstruction.
VOLUME OF PRODUCT IN COMMERCE
159 units.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR MAY 28, 2003
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