MARCH 20, 2002 02-11
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Shui Kou brand Bean Sauce in glass jars, net wt. 350 grams (12.33 oz.). Recall # F-324-2; Shui Kou brand Bean Sauce (with chilli0 in glass jars, net wt. 350 grams (12.33 oz.). Recall # F-325-2. The bar code on the products is barcode # 6 922007 197023. CODE Products are not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Jin Hua International Trading Inc., Brooklyn, NY, by telephone on July 14, 2000 Manufacturer: Lorin International (HK) Co., San Po Kong, Kowloon. State initiated recall is complete. REASON The products were held in leaking containers. VOLUME OF PRODUCT IN COMMERCE A total of 307 cases (36 jars per case). DISTRIBUTION NY, OH and MI.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Plasma Pheresis, Frozen Units, Recall # B-0906-2; b) Platelets, Pheresis, Leukoreduced, Recall # B-0907-2. CODE a) Unit 42KF05440, 42KF04174, 42KF03583; b) Units 42KF06239, 42KF06146 (split into two units), 42KF05851 (split into two units), 42KF05668, 42KF05440, 42KF04174, 42KF04089, 42KF04000(split into two units), 42KF03583, 42KF03505, 42KF03400 (split into two units). RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on October 26 and/or by letter on October 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Imuran, were distributed. VOLUME OF PRODUCT IN COMMERCE 17 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets, Recall # B—0908-2. CODE Unit 1842400. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter on January 4, 2002. Firm initiated recall is complete. REASON Platelets, which were prepared from a unit collected from a donor who had taken aspirin within three days of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0909-2. CODE Unit 16LW51679. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone and letter on January 21, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor whose hematocrit had not been documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0910-2; b) Platelets, Recall # B-0911-2; c) Fresh Frozen Plasma, Recall # B-0912-2. CODE a) b) and c) Unit 24KG42313. RECALLING FIRM/MANUFACTURER American National Red Cross Blood Services, River Valley Region, Louisville, KY, by letters dated December 10, 2001 and December 28, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION KY. _______________________ PRODUCT Recovered Plasma, Recall # B-0914-2. CODE FG47179. RECALLING FIRM/MANUFACTURER Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI, by facsimile on September 18, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Lupron, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0915-2. CODE Unit FK42096. RECALLING FIRM/MANUFACTURER Healthcare Provider Services Inc., dba Rhode Island Blood Center,Providence, RI, by telephone and facsimile on November 9, 2001. REASON Blood product, collected from a donor whose hemoglobin had not been documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT Red Blood Cells, Recall # B-0916-2. CODE Unit FJ75216. RECALLING FIRM/MANUFACTURER Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on October 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT Corneas, Recall # B-0919-2. CODE Units 2002-02-5003, 2002-02-5004. RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by facsimile and e-mail on February 13, 2002. Procurement Org.: Heartland Lions Eye Banks, St. Louis, MO. Firm initiated recall is complete. REASON Corneas that were collected from a donor who tested repeatedly reactive for HBsAg, by another tissue procurement organization, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Italy and Germany. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0923-2; b) Red Blood Cells, Leukoreduced, Recall # B-0924-2; c) Recovered Plasma, Recall # B-0925-2. CODE a) Units 7493387; b) and c) Unit, 1457901. RECALLING FIRM/MANUFACTURER New York Blood Center (Center West), A Division of New York Blood Center, Inc., New York, NY, by letter dated August 17, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NY, NJ and VA _______________________ PRODUCT Platelets Pheresis, Recall # B-0927-2. CODE Unit number FR16523. RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA, by telephone and letter on September 23, 1998. Firm initiated recall is complete. REASON Blood products, that was not tested for pH as required by the firm’s specifications, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0931-2; b) Fresh Frozen Plasma, Recall # B-0932-2. CODE a) and b) Unit number 36260-9283. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 16 and by letter dated June 20, 2001. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor based on the application of a tattoo within the previous 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0933-2; b) Fresh Frozen Plasma, Recall # B-0934-2. CODE a)Unit numbers 30117-0544, 30117-5933, and 30178-1542; b)Unit numbers 30117-0544 and 30117-5933. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Feb. 26 and by letter dated March 30, 2001. Testing/Reporting Firm: Blood Systems Laboratories, Tempe, AZ. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to human immunodeficiency virus (anti- HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MA, TX, ND and CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0935-2. CODE Unit numbers 10712-6766 and 10715-1125. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated November 14, 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 AZ. _______________________ PRODUCT Red Blood Cells, Recall # B-0936-2. CODE Unit number 36261-0611. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 15, 2001. Manufacturer: Blood Systems, Inc., Ventura, CA. 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 CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-937-2; b) Fresh Frozen Plasma, Recall # B-0938-2. CODE a) and b) Units 06FE37186 and 06FE38805. RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Los Angeles, CA, by letters dated June 21, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _______________________ PRODUCT Single Donor Plasma, Recall # B-0946-2. CODE Unit 38FV00125 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Fort Wayne, IN, by letter dated June 4, 2001. Firm initiated recall is complete. REASON Blood collected from a donor with a history of anti-IgA but was not labeled as having anti-IgA, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Allergenic Extract, 7-Tree Mix, Recall # B-0905-2. CODE Lot B611081A. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by fax on January 23, 2002. Firm initiated recall is complete. REASON Allergenic extract, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 vial. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0926-2. CODE Unit number 15-0129629. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Midland, TX, by telephone January 22, 2001. Manufacturer: Blood Systems, Inc., Odessa, TX. Firm initiated recall is complete. REASON Blood product, collected using automated equipment that had not been validated after repair, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0928-2; b) Fresh Frozen Plasma, Recall # B-0929-2. CODE a) and b) Unit number 10717-4434. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by telephone on Oct. 24 and by letter dated November 8, 2001. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. ______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0930-2. CODE Unit number 10709-4301. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by telephone on June 29 and by letter dated July 12, 2001. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ.END OF ENFORCEMENT REPORT FOR MARCH 20, 2002 ####
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