November 15, 2000 00-46________ PRODUCT a) Louie's brand Bean Sprouts packaged in 10-pound, 5-pound, and 12-ounce plastic bags; b) Louie's brand Chop Suey Mix packaged in 12-ounce plastic bags. Recall #F-037/038-1. CODE None. MANUFACTURER Louie Foods International, Fresno, California. RECALLED BY Manufacturer, by telephone on August 18, 2000, and by press release issued by the California State Food and Drug Branch on August 23, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 200-330 pounds were distributed. REASON Products may be contaminated with Salmonella. ________ PRODUCT Alma Mild Mixed Vegetables Giardinera, packed in 16-fluid ounce jars. Recall #F-039-1. CODE All product on market at time of recall initiation. MANUFACTURER Product of Greece. RECALLED BY Alma Foods Corporation, Stoughton, Massachusetts (repacker/distributor), by telephone on August 9, 2000, followed by letter faxed on August 10, 2000. Ongoing recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.. DISTRIBUTION Massachusetts and New York. QUANTITY Firm estimated that approximately 47 cases (12 jars per case) remained on the market at time of recall initiation REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ________ PRODUCT a) Cornmeal; b) Corn Flour; c) Snack Meal; d) Flaking Grits; e) Polenta Grits; f) Pregel/Cereal Binder. Recall #F-030/035-1. CODE a) Cornmeal under the following labels: (1) Cahokia Pride Yellow Corn Meal, packaged in 25-lb. bags coded 09/29/00, labeled as Manufactured for Cahokia Flour Company, St. Louis, MO (2) Dixianna Enriched Yellow Cornmeal, packaged in 25 lb. bags coded 09/29/00, labeled as Distributed by ConAgra, Inc., Omaha, NE (3) ConAgra Corn Meal 116C, 100-lb. bags coded 10/03/00, labeled as Manufactured by ConAgra Grain Processing Company, Omaha, NE (4) USA Cornmeal Yellow Enriched, Degermed, packaged in 25-kg. bags coded Lot 910, labeled Contract No. VEPD02706 (contract number on bag was incorrect and should have read VEPD02707) (5) Sysco Classic Yellow Corn Meal, packaged in plain brown 25-lb. bags coded 09/29/00, no responsible firm on the bag b) Corn Flour under the following labels (1) ConAgra Corn Flour 110, packaged in 50-lb. and 100- lb. bags coded 09/29/00, labeled as Manufactured By ConAgra Grain Processing Company, Omaha, NE (2) Bulk corn flour, unlabeled c) Snack Meal under the following labels: (1) ConAgra Snack Meal 128 Enr, packaged in 50-lb. bags coded 09/30/00, labeled as Manufactured by ConAgra Grain Processing Company, Omaha, NE (2) ConAgra Snack Meal 128, packaged in 50-lb. bags coded 09/30/00, labeled as Manufactured by ConAgra Grain Processing Co., Omaha, NE d) Flaking Grits under the following label: (1) Bulk Flaking Grits, product #4 e) Polenta Grits under the following label: (1) Alberto A-1 Coarse Cornmeal Polenta Grits 95B, packaged in 50-lb. bags coded 09/29/00 and 10/01/00, responsible firm on the label is Trujillo & Sons Inc., Miami, FL f) Pregel/Cereal Binder under the following label: (1) Bulk Pregel/cereal binder, product #201. MANUFACTURER ConAgra Corn Processing, Atchison, Kansas. RECALLED BY ConAgra Foods, Omaha, Nebraska/ConAgra Corn Processing, Atchison, Kansas, by telephone and/or letter beginning on October 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Missouri, Texas, Pennsylvania, Utah, Iowa, Tennessee, Michigan, Louisiana, Arkansas, Illinois, Florida. QUANTITY a) Cornmeal - 2,198.54 cwt (hundred weight); b) Corn Flour - 4,167.80 cwt; c) Snack Meal - 1,062.50 cwt; d) Flaking Grits - 4,355 cwt; e) Polenta Grits - 1,350 cwt; f) Pregel/Cereal Binder - 1,371 cwt. REASON Products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. ________ PRODUCT Lynn Wilson's Stone Ground Corn Tortillas, 8-ounces, 12 count; 11-ounce, 12 count; 32-ounce 36 count. Recall #F-036-1. CODE 8-ounce, 12 count bag, UPC 71221 70010 11-ounce, 10 count bag, UPC 71221 70210 32-ounce, 36 count bag, UPC 71221 70810 All Date codes: 12/7, 12/10, 12/14, 12/17. MANUFACTURER Wilson Foods Company, Salt Lake City, Utah. RECALLED BY Manufacturer, by telephone, followed by faxed latter, and by press release on November 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Utah, Idaho, Montana, Washington state. QUANTITY The following amounts were shipped: 487 cases of the 8-ounce bags @ 12/12 ct bags per case = 70,128 tortillas; 472 cases of the 11-ounce bags @ 12/10 ct bags per case = 56,640 tortillas; 713 cases of 32-ounce bags @ 9/36 ct bags per case = 231,012 tortillas. REASON The products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. _______ UPDATES Recall #F-912/913-0, Taco Bell Home Originals Taco Shells and Taco Bell Home Originals Taco Dinner, recalled by Kraft Foods Inc., Northfield, Illinois, which appeared in the October 4, 2000 Enforcement Report should read: REASON: The products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption. Recall #F-023/026-1, Tortillas, Shells, Tostadas, and Chips, recalled by Mission Foods, Irving, Texas, which appeared in the November 1, 2000 Enforcement Report should read: DISTRIBUTION: Nationwide, Canada, Korea. REASON: The products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ________ PRODUCT Alma Fancy Pickled Cauliflower, in 16-fluid ounce glass jars. Recall #F- 040-1. CODE All product on the market at time of recall initiation. MANUFACTURER Product of Greece. RECALLED BY Alma Food Corporation, Stoughton, Massachusetts (distributor), by telephone on August 9, 2000, followed by letter faxed on August 10, 2000. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Massachusetts and New York. QUANTITY Firm estimated that 3 cases (12 jars per case) remained on market at time of recall initiation. REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ________ PRODUCT Trasylol (aprotinin injection), 10,000 K.I.U./mL, 100 and 200 ml Sterile Solution, for intravenous infusion, Rx indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary artery bypass graft surgery. NDC #0026-8196-36 (100 mL), NDC 0026-8197-63 (200 mL). Recall #D-013-1. CODE Lot Numbers: ODIA EXP 01/02, OEHB EXP 01/02, OEFM EXP 01/02. MANUFACTURER Bayer AG, Leverkusen, Germany. RECALLED BY Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, by letter dated October 6, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 29,514 units were distributed. REASON Lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ________ PRODUCT Platelets, Pheresis. Recall #B-107-1. CODE Unit #0586993. MANUFACTURER Coral Therapeutics, Inc., Braintree, Massachusetts. RECALLED BY Manufacturer, by telephone on August 29, 1996. Firm-initiated recall complete. DISTRIBUTION Maine. QUANTITY 1 unit was distributed. REASON Blood product tested positive for anti-HCV. ________ PRODUCT Red Blood Cells. Recall #B-214-1. CODE Unit #42FX89592. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated April 20, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis. Recall #B-227/229-1. CODE Unit Numbers: a) 18FT25111; b) 18FT25111; c) 18P40771. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on July 5, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-230/231-1. CODE Unit #18FT34246. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-233-1. CODE Unit #18FR49796 and 18FW08848. MANUFACTURER American Red Cross, Muskegon, Michigan. RECALLED BY American Red Cross, Lansing, Michigan, by letter on August 31, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan and California. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-237-1. CODE Unit #18FS40538. MANUFACTURER American Red Cross, Muskegon, Michigan. RECALLED BY American Red Cross, Lansing, Michigan, by letter on June 8, 2000, and August 4, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-238-1. CODE Unit Numbers: 26159-0168 and 26160-9973. MANUFACTURER Blood Systems, Inc., Rogers, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 17, 1999, and by letter dated January 14, 2000. Firm-initiated recall complete. DISTRIBUTION Arkansas and Texas. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-240/242-1. CODE Unit Numbers: a) 13L87732, 13L91123; b) 13L87732; c) 13L87732, 13L91123. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letters on June 16 or 30, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan, California, New York. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-253-1. CODE Unit #M97-0103. MANUFACTURER Union Memorial Hospital, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated February 5, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for anti-HCV. ________ PRODUCT Source Plasma. Recall #B-254-1. CODE Unit #80523048. MANUFACTURER NABI Biomedical Center, Pensacola, Florida. RECALLED BY NABI Biomedical Center, Boca Raton, Florida, by letter dated February 26, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for anti-HCV. ________ PRODUCT Platelets, Pheresis. Recall #B-255-1. CODE Unit #97K12609. MANUFACTURER National Institute of Health, Warren G. Magnuson Clinical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by letter dated June 29, 1998. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Source Plasma. Recall #B-258-1. CODE Unit #15329042. MANUFACTURER NABI Biomedical Center, Huntington, West Virginia. RECALLED BY Manufacturer, by letter on June 5, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was not asked any of the pre-donation screening questions. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-259/262-1. CODE Unit Numbers: a) 6121790, 2166913, 7770084; b) 2166913; c) 2166913; d) 6121790. MANUFACTURER Life Source, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on October 14, 2000, and by fax dated October 6, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois, California, Scotland. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 1 unit distributed. REASON Blood products tested negative for the antibody to the human T- lymphotropic virus, but were collected from a donor who previously tested repeatedly reactive for anti-HTLV. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced and Irradiated; c) Platelets, Pooled; d) Recovered Plasma. Recall #B-267/270-1. CODE Unit Numbers: a) LW93016; b) LW89401; c) PO1447; d) LW93016. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on August 11, 2000, and by letters dated August 15, 2000 and December 10, 1999. Firm-initiated recall complete. DISTRIBUTION Wisconsin and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Source Plasma. Recall #B-276-1. CODE Unit Numbers: 33-3LS076, 33-3K7728, 33-3K7775, 33-3K7813, 33-3K7870. MANUFACTURER Aventis Bio-Services, Inc., West Allis, Wisconsin. RECALLED BY Aventis Bio-Services, Inc., Knoxville, Tennessee, by letter dated April 5, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois and Germany. QUANTITY 5 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Source Plasma. Recall #B-277-1. CODE Unit Numbers: 17114516, 17113014, 17111713. MANUFACTURER Interstate Blood Bank, Inc. of Wisconsin, Kenosha, Wisconsin. RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee, by fax dated June 29, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who had body piercing within 12 months of donation. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-278-1. CODE Unit #LH52904. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on January 6, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION. Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-279-1. CODE Unit #LH53504. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on January 7, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. __________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-280-1. CODE Unit Numbers: 24205-9415-01 and 24205-9415-02. MANUFACTURER Blood Systems, Inc., United Blood Services, Rapid City, South Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 11, 2000, and by letter dated February 8, 2000. Firm-initiated recall complete. DISTRIBUTION South Dakota. QUANTITY 2 units were distributed. REASON Blood products had high platelet counts. ________ PRODUCT Red Blood Cells. Recall #B-282-1. CODE Unit #LW69352 and LW80229. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on October 12, 1999, and August 11, 2000, and by letters dated August 15 and 16, 2000, and September 7, 1999. Firm- initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol). ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-291/292-1. CODE Unit Numbers: a) R07374; b) R07372. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on September 2, 1999, and by letters dated October 6, 1999, and August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in a manner that compromises the sterility of the units. __________ PRODUCT Whole Blood. Recall #B-297-1. CODE Unit #166482. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on April 20, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product tested positive for Group D Streptococcus, was distributed after receiving post donation information concerning a gastrointestinal illness. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-301/302-1. CODE Unit #21GY59346. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated August 11, 2000. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-303/304-1. CODE Unit #5132756. MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by letter dated June 5, 2000. Firm-initiated recall complete. DISTRIBUTION Texas and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Recovered Plasma. Recall #B-307-1. CODE Unit #7864522. MANUFACTURER Meek Blood Center, Hendrick Medical Center, Abilene, Texas. RECALLED BY Manufacturer, by telephone and fax on August 24, 2000. Firm-initiated recall complete. DISTRIBUTION Colorado. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose suitability was not adequately determined. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Source Leukocytes, For Research Use Only. Recall #B-308/311-1. CODE Unit #3608757. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax dated December 23, 1999 or by telephone on January 4, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ________ PRODUCT Platelets for Non-Injectable Use. Recall #B-234-1. CODE Unit #18FW08848. MANUFACTURER American Red Cross, Muskegon, Michigan. RECALLED BY American Red Cross, Lansing, Michigan, by letter on August 31, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan and California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-239-1. CODE Unit Numbers: 41-42407 and 61-70174. MANUFACTURER Michigan Community Blood Centers, Grand Rapids, Michigan. RECALLED BY Manufacturer, by letters in February 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units were distributed. REASON Blood product was collected from a donor who had a history of pernicius anemia. ________ PRODUCT Platelets, Pheresis. Recall #B-256-1. CODE 97K11436, 97K11502, 97K11505, 97K11583, 97K11593, 97K11804, 97K11886, 97K11991, 97K12081. MANUFACTURER National Institute of Health, Warren G Magnuson Clinical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by letter dated August 17, 2000. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 9 units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Red Blood Cells. Recall #B-257-1. CODE Unit #98K03043 and 98K03228. MANUFACTURER National Institute of Health, Warren G. Magnuson Clinical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by letter dated August 17, 2000. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 2 units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Red Blood Cells. Recall #B-263-1. CODE Unit #LS44555-1 and LS44555-2. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on January 13, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 2 units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Fresh Frozen Plasma. Recall #B-264-1. CODE Unit Numbers: LW88030 and LW88034. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on June 22, 1999, and letter on August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 2 units were distributed. REASON Two units of Fresh Frozen Plasma were not separated and frozen within eight hours of phlebotomy. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-265/266-1. CODE Unit #30173-1469. MANUFACTURER Blood Systems, Inc., Bismark, North Dakota. COLLECTION SITE Blood Systems, Inc., Minot, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 16, 2000. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of ulcerative colitis. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Platelets, Pooled; d) Fresh Frozen Plasma; e) Recovered Plasma. Recall #B-271/275-1. CODE Unit Numbers: a) FR23981, FR26646; b) LE22353 c) P02582; d) LE22353; e) FR23981. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on August 11 and 14, 2000, and September 29, 2000, and by letters dated August 15, 2000 and January 18, 2000. Firm- initiated recall complete. DISTRIBUTION Tennessee, Wisconsin, Switzerland. QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit distributed. REASON Blood products were collected from a donor who received a tissue transplant (surgery) within a year of donation. ________ PRODUCT Recovered Plasma. Recall #B-283-1. CODE Unit Numbers: LW69352 and LW80229. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by letter September 7, 1999. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol). ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-295-1. CODE Unit #30176-1612. MANUFACTURER Blood Systems, Inc., United Blood Services, Bismark, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on April 7, 2000, and by letter dated April 26, 2000. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Red Blood Cells failed red cell recovery ratio.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III END OF ENFORCEMENT REPORT FOR NOVEMBER 15, 2000 ####
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