FDA

Enforcement Report

January 29, 2003
03-05

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_____________________________
PRODUCT
SWEET POTATO, N.W. 6oz (170g +/- 5g), packaged in a clear flexible plastic bag. PRODUCT CHINA. Firm on label - JIN HUA INT'L TRADING INC. Barcode # 21793 00010.
Recall # F-165-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden Dynasty Trading, Inc., Brooklyn, NY, by telephone and visit in April 2002.
Manufacturer: Yeung Kong Food Co., Canton, China. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
47 cases (100 - 6 oz. packages per case).
DISTRIBUTION
NY.

_____________________________
PRODUCT
FRATERNITY brand Pickled Lotus Rootlet Slice, NET WT: 16oz (454gr), packed in a glass jar with red lid. Product of VIETNAM. Barcode # 935005 308108. Recall # F-166-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading, Inc., Brooklyn, NY, by press release on August 7, 2002.
Manufacturer: Vina Hung (Co So Vina Hung) Ho Chi Minh City, Vietnam. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
47 cases (24 - 16 oz. jars per case) were distributed.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Rice Fruit Cake, Delicious, packaged in a plastic bag containing 12 individually wrapped cakes, net wt. 250 g (8.75 oz.). Product of Taiwan. Barcode # 711931 220400. Recall # F-167-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starway Inc., Brooklyn, NY, by press release on July 8, 2002 and letter on July 10, 2002 and 2nd press release on August 8, 2002.
Manufacturer: DYI Hong Co., Ltd. Taipei, Taiwan ROC. State initiated recall is complete.
REASON
The product contained undeclared eggs and walnuts.
VOLUME OF PRODUCT IN COMMERCE
19 cases (10 - 8.5 oz packages per case).
DISTRIBUTION
Asian retail markets in NY, NJ, FL, PA and MI.

_____________________________
PRODUCT
Frozen Breaded Catfish, Net Weight 15 lbs. Recall # 168-3.
CODE
14G91.
RECALLING FIRM/MANUFACTURER
Carolina Classics Catfish Inc., Ayden, NC, by letter on October 10, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared ingredients including ones derived from egg, soy, milk, wheat, and corn.
VOLUME OF PRODUCT IN COMMERCE
7160 cases (in bulk /15 lbs per case).
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Tiffany Bamboo Shoots, net weight 300 g, packaged in a heat-sealed plastic bag. Barcode # 711130 000230.
Recall # F-170-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tiffany Food Corp., Brooklyn, NY, by visit in July 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
10 cases (50 packages per case) were distributed.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_____________________________
PRODUCT
ESTRACE tablets (estradiol tablets, USP), 2 mg, 100 and 500 count bottles, Rx Only. Recall # D-116-3.
CODE
100 Count bottles - Lot no. 0K28404, Exp. Date Oct-2003, 500 Count bottles - Lot no. 0J41630, Exp. Date Oct-2003.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letters on November 11, 2002. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
4,587 bottles.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

****CORRECTION****

Enforcement Report 03-03, January 15, 2003, Recall # D-068-3, under code information, section b, the lot number for unit dose 100's were missing. It should read: lot # 9000846.

_____________________________
PRODUCT
a) MEGACE tablets (megestrol acetate, USP), 20 mg,100 count
bottles, Rx Only. Recall # D-114-3;
b) MEGACE tablets (megestrol acetate, USP), 40 mg, 100
count bottles, Rx Only. Recall # D-115-3.
CODE
a) Megace 20 mg TABLETS

b) Megace 40 mg TABLETS

RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letters on November 5, 2002. Firm initiated recall is ongoing.
REASON
Dissolution Failure; tablets are below specification.
VOLUME OF PRODUCT IN COMMERCE
44,779 bottles (20 and 40 mg).
DISTRIBUTION
United States and the following countries Buenos Aires, Argentina, Seoul, Korea, Rep. Of South Africa, Santiago, Chile, Phillipines, and Vietnam.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Human Cornea Tissue, Recall # B-0244-3.
CODE
Units (2 units) C-1020808-OS and C-1020808-OD.
RECALLING FIRM/MANUFACTURER
Illinois Eye-Bank, Chicago, IL, by telephone on October 21, 2002 and by letter dated November 4, 2002. Firm initiated recall is complete.
REASON
Corneas, which were collected from a donor who had not been properly evaluated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
New York.

_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0381-3.
CODE
Unit LC15631.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on February 26, 2002 and by letter dated February 28, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0388-3.
b) Recovered Plasma, Recall # B-0389-3.
CODE
a) and b) Unit KC05708.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on September 12, 2002 and by letter dated September 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.

_____________________________
PRODUCT
Source Plasma, Recall # B-0396-3.
CODE
Unit 00OWID9927.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by letter dated September 26, 2000.
Manufacturer: Community Bio-Resources, Inc., Oshkosh, WI. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have affected the sensitivity of viral marker test results, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0397-3.
CODE
Unit 10725-3851.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on February 19, 2002. Firm initiated recall is complete.
REASON
Blood product, that lacked assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0405-3;
b) Recovered Plasma. Recall # B-0406-3.
CODE
a) and b) Unit 17KN93018.
RECALLING FIRM/MANUFACTURER
American Red Cross, North Central Blood Services, St. Paul, MN, by letter dated April 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_____________________________
PRODUCT
Human Cornea Tissue, Recall # B-0408-3.
CODE
2002-08-2033, 2002-08-2034.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Banks-Illinois Branch, Columbia, MO, by letter dated November 18, 2002. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor who subsequently tested repeatedly reactive for HIV-1 p24 antigen by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
GA and IL.

_____________________________
PRODUCT
Human Cornea Tissue, Recall # B-0409-3.
CODE
WX-02-09-001-L1, WX-02-09-001-R1.
RECALLING FIRM/MANUFACTURER
Medical Eye Bank of West Virginia, Inc., Charleston, WV, by letters dated September 12 and 18 2002. Firm initiated recall is complete.
REASON
Human cornea, collected from a donor who subsequently tested positive for IgM antibody to the Hepatitis B core antigen (Anti-HBc) by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
OH and CO.

_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0412-3.
CODE
Unit 53P88073.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD by telephone on August 2, 2002. Firm initiated recall is complete.
REASON
Platelets, corresponding to a unit of Platelets that were implicated in a transfusion reaction, and were positive for Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0420-3;
b) Recovered Plasma, Recall # B-0421-3.
CODE
a) and b) Units 38LC35843, 38H71558, 38LC19990.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by letter or fax dated September 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IN and CA.

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0447-3.
CODE
Unit FT98256.
RECALLING FIRM/MANUFACTURER
Inova Health System/Blood Donor Services, Annandale, VA, by letter dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an HIV group O high risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Platelets, Pheresis, Leukoreduced, Recall # B-0448-3.
CODE
(2nd of split unit) Unit 7743026.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on February 28, 2001. Firm initiated recall is complete.
REASON
Blood product, which had a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced, Recall # B-0449-3.
CODE
Units 5881661(split unit), 6943861.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on August 15, 2002. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but
that failed the quality control specification for white
blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IN.

_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0450-3.
CODE
Units 2670309, 2670310.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on November 11, 2002. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but
that failed the quality control specification for white
blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_____________________________
PRODUCT
Misys Blood Bank System. Recall # B-0455-3.
CODE
Version 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson, AZ, by letter dated April 2, 2002. Firm initiated recall is ongoing.
REASON
Defect in the design of blood bank software programs could result in the release of unsuitable blood product.
VOLUME OF PRODUCT IN COMMERCE
3 versions.
DISTRIBUTION
Nationwide and in Canada, United Kingdom, Bermuda and Saudi Arabia.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0456-3.
Recovered Plasma, Recall # B-0457-3.
CODE
a) and b) Unit numbers 13FC19554 and 13GC79582.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by fax on February 6, 2002, letters on February 8, 2002 and April 22, 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
4 units.
DISTRIBUTION
MI and CA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0458-3.
b) Recovered Plasma, Recall # B-0459-3.
CODE
a) and b) Unit number 8517011.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by fax on October 17, 2002 and by letter on October 24, 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 jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH and Austria.

_____________________________
PRODUCT
a) Platelets, Recall # B-0460-3.
b) Fresh Frozen Plasma, Recall # B-0461-3.
CODE
a) and b) Unit number 13FH96588.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on June 12 and 20, 2002 and by letter on June 24, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0462-3.
CODE
Unit number 38H87210.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on July 1, 2002. Firm initiated recall is complete.
REASON
Blood product that failed to meet the minimum specification for product volume was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_____________________________
PRODUCT
Platelets Pheresis, Recall # B-0463-3.
CODE
Unit number 13P88129.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on July 8, 2002. Firm initiated recall is complete.
REASON
Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0464-3.
CODE
Unit number 9168951.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on October 18, 2002. Firm initiated recall is complete.
REASON
Platelets Pheresis labeled with an incorrect platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_____________________________
PRODUCT
Platelets Pheresis, Recall # B-0465-3.
CODE
Unit numbers 2056186 and 2059933.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on March 15, 2001 and by letter on April 11, 2001. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
DE.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0382-3.
CODE
Units 24214-8422 (split into products 04741 and 04761); 24214-8429.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 13, 2002.
Manufacturer: United Blood Services, Rapid City, SC. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that was not validated following repairs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
SD.

_____________________________
PRODUCT
Platelets, Recall # B-0383-3.
CODE
Unit 24215-1295.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 15, 2002.
Manufacturer: United Blood Services, Rapid City, SC. Firm initiated recall is complete.
REASON
Blood product, which may have contained the additive solution Adsol, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.

_____________________________
PRODUCT
a) Cryoprecipitated AHF, Pooled, Recall # B-0384-3;
b) Recovered Plasma, Recall # B-0385-3.
CODE
a) Units P25027, P25028, P25050;
b) Units LE46895, LE47274, LE46896, LS78454.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, WI, by letter dated July 2, 2002 and by telephone on July 3, 2002. Firm initiated recall is complete.
REASON
Blood products, stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
WI.

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0386-3.
CODE
Unit 53L23026.
RECALLING FIRM/MANUFACTURER
American Red Cross, Baltimore, MD, by letter dated August 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura (ITP), was distributed.

VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Platelets, Recall # B-0387-3.
CODE
Unit 24217-1824.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 22, 2002.
Manufacturer: United Blood Services, Rapid City, SD. Firm initiated recall is complete.
REASON
Blood product, that incorrectly had the Adsol additive included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.

_____________________________
PRODUCT
Red Blood Cells, Deglycerolized, Recall # B-0391-3.
CODE
Unit 0271112.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, MN, by letter dated May 2, 2002. Firm initiated recall is complete.
REASON
Blood product, that failed the parameter for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MN.

_____________________________
PRODUCT
Source Plasma, Recall # B-0392-3.
CODE
Units CM047863, CM048255, CM046787, CM048234, CM047627, CM047792, CM047087, CM047057, CM047391, CM047486, CM047826, CM046778, CM047380, CM047639, CM047818, CM046781, CM048064, CM048238, CM0478358, CM047777, CM047038, CM048215, CM048191, CM047216, CM048248, CM047641, CM048312, CM047904, CM048205, CM048326, CM047507, CM047755, CM046911, CM047690, CM048231, CM048171, CM047749, CM047315, CM047247, CM047654, CM048114, CM048330, CM047010, CM047899, CM047849, CM048275, CM048095, CM047870, CM048034, CM048212.
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals, Coon Rapids, MN, by fax dated December 31, 2001, January 2, 2002 and January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not asked all of the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Source Plasma, Recall # B-0395-3.
CODE
Unit OOGWIC2850.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by letter dated June 16, 2000.
Manufacturer: Community Bio-Resources, Inc., Green Bay, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received the Heptavax within 48 hours of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0398-3;
b) Platelets, Recall # B-0399-3.
CODE
a) Units 0834108, 0834109, 0834110, 0834111, 0834112,
0834113, 0834114, 0834115, 0834116, 0834117;
b) Units 0834108, 0834109, 10834110, 0834111, 0834112,
0834115, 0834116, 0834117.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, MN, by telephone on June 14, 2001 and by letter dated July 2, 2001. Firm initiated recall is complete.
REASON
Blood products, collected using expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
MN.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0400-3;
b) Recovered Plasma, Recall # B-0401-3.
CODE
a) and b) Unit 53GE62882.
RECALLING FIRM/MANUFACTURER
American Red Cross, Baltimore, MD, by letter dated December 14, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not done, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-402-3.
CODE
Units KM40667, KM40681
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on September 23, 2002 and by letter dated October 3, 2002. Firm initiated recall is complete.
REASON
Plateletpheresis product, without platelets counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.

_____________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-0403-3.
CODE
Units 53C22732, 53GQ98893.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by telephone on July 6, 2002 and by letter dated August 2, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0404-3.
CODE
Units 32KP26197 - split into two products.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated May 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility was not accurately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI and IL.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0407-3.
CODE
Units 0953239, 0970131, 0936715.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, MN, by telephone on August 28, 2002. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper storage temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MN.

_____________________________
PRODUCT
Source Plasma, Recall # B-0419-3.
CODE
Unit 0410868229, 0410867740 and 0410867197.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by letter dated October 5, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was
inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0466-3.
CODE
Unit number 18FX43642.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on August 6, 2002. Firm initiated recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_____________________________
PRODUCT
IMx Glycated Hemoglobin Reagent Sets, list 1A86-88;
the set is composed of the IMx Gylcated Hemoglobin Reagent Pack, list 1A86-20, which contains 1 bottle (10.5 mL)Polyanion Affinity Reagent, 1 bottle (11.1 mL) Lysis Reagent, 1 bottle (10.5 mL) Sorbitol in buffer and 1 bottle (28.0 mL) Wash Buffer, and 1 box (100) Ion Capture Reaction Cells, list 5A57-01. Recall # Z-0445-3.
CODE
lot numbers 85129M200, 85129M201, 85128M200, 83668M200, 85127M200, 84879M100, 84880M100, 84876M100, 84876M101, 83669M200, 83667M200, 83666M200, 83665M200, 82339M200, 82338M200, 82337M200, 75768M300, 75767M300, 75766M300.
RECALLING FIRM/MANUFACTURER
Abbott laboratories, Inc., Abbott Park, IL, by letters dated July 2, 2002. Firm initiated recall is ongoing.
REASON
Low Control reads high, out of insert range.
VOLUME OF PRODUCT IN COMMERCE
38,877 kits.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS I

_____________________________
PRODUCT
Merrick Brand Pet Treats Delicatessen Style Beef Steak Patties, packaged 75 treats per case. The case converts into a display container for retail sale. Treats are not individually wrapped, however, the case is shrink wrapped after closure. Recall # V-007-3.
CODE
Lot PG1621 recalled from Canada
RECALLING FIRM/MANUFACTURER
Merrick Pet Care, Hereford, TX, by press release on September 19, 2002. Firm initiated recall is complete.
REASON
Pet treats containing salmonella.
VOLUME OF PRODUCT IN COMMERCE
330 cases of 75 patties each.
DISTRIBUTION
Canada.

END OF ENFORCEMENT REPORT FOR JANUARY 29, 2003

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