November 8, 2000 00-45RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Smoked Turkey Sandwiches, in rigid plastic wedge pack with a flex plastic overwrap sealing the top, net weight 4 ounces. Recall #F-029-1. CODE 092500. MANUFACTURER Jumbo Foods Inc., Mukilteo, Washington. RECALLED BY Manufacturer, by press release, visit and telephone on September 5, 2000. Completed recall resulted from sample analysis and follow-up by the Washington State Department of Agriculture. DISTRIBUTION Washington state, Oregon, Idaho, Arizona, California. QUANTITY 7,812 sandwiches were distributed. REASON Product is contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Vita brand Diet Strawberry Preserves, in 280 gram (10 ounce) glass jars. Recall #F-027-1. CODE None. All product containing the unapproved color additive Ponceau 4R. MANUFACTURER Vita Quality Foods, Petach Tikva, Israel. RECALLED BY International Gold Star Trading Corporation, Brooklyn, New York, by telephone on February 2, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 9 cases (12 jars per case) were distributed. REASON Product contained the unapproved color additive Ponceau 4R ________ PRODUCT Skinners Nuts Salted Red Pistachios, in 1 ounce, 1 3/4 ounce, 2 3/8 ounce, 3 1/4 ounce, and 5 3/8ounce bags. Recall #F-028-1. CODE UPC# Item# Description 737130400H 01010400H/1 $0.50 Red Pistachio 7371311503 01011503 $0.99 Red Pistachio 7371311504 01011504 $1.49 Red Pistachio 7371311505 01011505 $1.99 Red Pistachio 7371311507 01011507 $2.99 Red Pistachio. MANUFACTURER Skinner's Salted Nuts, Inc., Carlstadt, New Jersey. RECALLED BY Manufacturer, by letter on September 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York, New Jersey, Connecticut, Maryland, Puerto Rico. QUANTITY 6,467 cases were distributed. REASON Product contains undeclared FD&C Red No. 3 and FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT a) Qualitest brand Prednisone Tablets, 10 mg, in 21 and 48 count, unit dose pack, NDC #0603-5333-31 and 0603-5333-15; b) Dexamethasone Tablets, USP, 0.75 mg, 12 count, unit dose pack, under the Qualitest and Vintage labels. Recall #D-011/012-1. CODE Lot Numbers: a) 071F0A and 071F0B; b) Qualitest Dexamethasone Tablets, USP, 0.75mg, NDC #0603-3191-11, Lot numbers: 022D9A, 022D9B, 022D9C, 022D9D, 022D9E, 014E9A, 014E9C, 014E9D, 053F9A, 052L9B, 052L9C Dexamethasone Tablets, USP, 0.75mg, NDC #0254-2667-06, Lot numbers: 022D9F, 014E9B, 014E9E, 052L9A Vintage Dexamethasone Tablets, USP, 0.75mg, Rx, NDC #0254-2667-06, Lot numbers: 014E9B, 014E9E, 052L9A, 022D9F. MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, Alabama. RECALLED BY Manufacturer, by telephone followed by letter dated August 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION a) Nationwide; b) Nationwide and Puerto Rico. QUANTITY a) 4,483 packages; b) 179,728 packages were distributed. REASON Lack of data to support labeled expiration date.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Morphine Sulfate Injection, USP (with additive), Rx for the relief of severe pain: a) 1 MG/ML, NDC 61703-219-75 (30 ML (LONG) X 1 VIAL) NDC 61703-219-80 (10 ML X 1 VIAL) NDC 61703-219-85 (30 ML (SHORT) X 1 VIAL) b) 5 MG/ML NDC 61703-221-75 (30 ML (LONG) X 1 VIAL) NDC 61703-221-85 (30 ML (SHORT) X 1 VIAL) c) 10MG/ML NDC 61703-231-32 (10 ML X 10 VIALS) d) 25 MG/ML NDC 61703-223-21 (20 ML X 10 VIALS) NDC 61703-223-43 (40 ML X 10 VIALS) e) 50 MG/ML NDC 61703-225-21 (20 ML X 10 VIALS) NDC 61703-225-43 (40 ML X 10 VIALS). Recall #D-003/007-1. CODE LOT NO. EXP. DATE 8151 9/00 8151039 11/00 8152-33, 36, 37 10/00 8152-38 11/00 8153-29, 32 9/00 8153-35 10/00 81510-31 9/00 9151-1, 1A 12/00 9151-9 3/01 9151-15, 21, 25 4/01 9151-26 7/01 9151-32, 35 8/01 9151-46, 56 10/01 9151-57, 59 11/01 9152-4, 7 2/01 9152-11, 12, 13 3/01 9152-23, 24 4/01 9152-34, 36 8/01 9152-48 10/01 9152-62 11/01 9153-3 1/01 9153-10, 14 3/01 9154-8 3/01 9154-50 10/01 9156-42 9/01 9157-33 8/01 9157-43 10/01 9157-58 11/01 9158-18 4/01 9159-5 2/01 9159-16, 20 4/01 9159-22 5/01 9159-28 7/01 9159-31 8/01 9159-38, 39, 40 9/01 9159-49 10/01 9159-51, 52, 61 11/01 91510-2, 6 1/01 91510-17, 19 4/01 91510-29 6/01 91510-30 8/01 91510-37, 41, 44, 45 9/01 91510-53, 54 10/01 91519-55 11/01 0151-4, 5 12/01 0151-21, 23, 24 2/02 0152-9, 10, 16 1/02 0152-25 2/02 0152-28, 31 3/02 0153-1 12/01 0153-12 1/02 0155-22 2/02 0156-2 12/01 0156-17 1/02 0157-6 12/01 0157-29 3/02 0158-7 12/01 0159-3, 8 12/01 0159-11, 13 1/02 0159-32, 33 4/02 01510-19, 20 2/02. MANUFACTURER Faulding Pharmaceutical PR, Inc., Aguadilla, Puerto Rico. RECALLED BY Manufacturer, by letter mailed on September 12, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 285,343 units were distributed. REASON Misbranding - Product labeled to contain 0.1% sodium bisulfite rather than the actual amount of 0.2%. ________ PRODUCT a) Doxycycline Hyclate Capsules, USP, 50 mg, in bottles of 50, NDC #0364- 2023-50; b) Doxycycline Hyclate Capsules, 100 mg, in bottles of 50 and 500, NDC #0364-2033-05, Schein Pharmaceutical label. Recall #D-008/009-1. CODE Lot Numbers: P9H0299 EXP AUG 01 and P9E0179 EXP MAY 01. MANUFACTURER Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaeutical, Inc., Humacao, Puerto Rico. RECALLED BY Manufacturer, by mail on August 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 7,590 bottles of 50 (lot P9H0299); 28,205 bottles of 50 (lot P9E0179) and 2,888 bottles of 500 (lot P9E0179) were distributed. REASON Product exceeds USP limit for water content.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Platelets, Pheresis; b) Platelets, Pheresis, Irradiated. Recall #B-140/141-1. CODE Unit Numbers: a) 18216-7680-01, 18216-7751-01; b) 18216-7680-02. MANUFACTURER UNITED Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 21, 1999. Firm-initiated recall complete. DISTRIBUTION Wyoming. QUANTITY a) 2 units; b) 1 unit. REASON Blood products had unacceptable platelet counts. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-161-1. CODE Unit #3499909. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and by letter on December 30, 1997. Firm- initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Platelets, Pheresis was leukoreduced by filtration greater than 72 hours past the time of collection. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-162-1. CODE Unit #3568224. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by fax on September 9, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Platelets, Pheresis were leukoreduced by filtration greater than 72 hours past the time of collection. ________ PRODUCT Platelets Pheresis, Irradiated. Recall #B-172-1. CODE Unit #18P41974 (split unit). MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated April 5, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 split unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-173-1. CODE Unit numbers: 38-19676, 62-20275, 62-29892. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan, by letter dated March 10, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan, Mississippi. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor with Graves Disease. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-174/175-1. CODE Unit #21N08794. MANUFACTURER American Red Cross Blood Service, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on April 6, 2000, followed by letter dated April 12, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose blood donation record had two confidential unit exclusion stickers attached. ________ PRODUCT Source Plasma. Recall #B-176-1. CODE Unit #C-10868-079. MANUFACTURER Alpha Therapeutic Corporation, Seattle, Washington. RECALLED BY Alpha Therapeutic Corporation, Los Angeles, California, by fax on May 15, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was previously deferred for unexplained needle marks. ________ PRODUCT a) Platelets, Pheresis, Leukoreduced; b) Fresh Frozen Plasma. Recall #B- 182/183-1. CODE Unit #9030157. MANUFACTURER Blood Bank of Delaware, Inc., Newark, Delaware. RECALLED BY Manufacturer, by telephone on February 11, 2000. Firm-initiated recall complete. DISTRIBUTION Delaware. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Proscar. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-184/185-1. CODE Unit #16LW38680. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated May 31, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-186/187-1. CODE Unit numbers: a) 1637600, 1653535, 1668881; b) 1637600. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated August 23, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY a) 3 units; b) 1 unit distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-188-1. CODE Unit #41FY97807. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated March 29, 1999. Firm-initiated recall complete. DISTRIBUTED Alabama. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-189/190-1. CODE Unit #0334343. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter or fax on May 5 and 17, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Red Blood Cells. Recall #B-191-1. CODE Unit Numbers: 15006-1226 and 15387-3393. MANUFACTURER Blood Systems, Inc., South Plains Blood Services, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated November 23, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 2 units were distributed. REASON Blood product was collected from a donor taking the Asacol. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall #B-193-1. CODE Split Units 26158-4652-01, 26158-4652-02, 26158-4653-01, 26158-4653-02, 26158-4643-02. MANUFACTURER United Blood Services, Hot Springs, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 15, 2000, and by letter dated March 2, 2000. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 5 split units were distributed. REASON Blood products, which had unacceptable platelet counts. ________ PRODUCT Source Plasma. Recall #B-194-1. CODE Unit #99OW14310. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated May 5, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that compromises the sterility of the unit. ________ PRODUCT Red Blood Cells. Recall #B-195-1. CODE Unit #21KK27439. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated August 3, 2000. Firm-initiated recall complete. DISTRIBUTION California. 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. Recall #B-196/197-1. CODE Unit #KL64588. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated December 3, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component 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) Recovered Plasma. Recall #B-200/201-1. CODE Unit #21FT28071. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated July 19, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had a tattoo within 12 months of donation. ________ PRODUCT Source Plasma. Recall #B-202-1. CODE Unit numbers: G-77949-009, G-78929-009, G-76921-009, G-79859-009, G-80377-009, G-80718-009, G-81234-009, G-81567-009, G-82209-009, G-82579-009, G-83023-009, G-83247-009, G-83858-009, G-84164-009, G-84735-009, G-85109-009, G-85541-009, G-85952-009, G-86316-009, G-87011-009, G-87355-009, G-88293-009, G-88812-009, G-89246-009. MANUFACTURER Alpha Therapeutic Corporation, Tacoma, Washington. RECALLED BY Manufacturer, by fax dated January 21, 2000. Firm-initiated recall complete. DISTRIBUTION Spain. QUANTITY 24 units were distributed. REASON Blood products were collected from a donor who had body piercing within twelve months of donation. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma, Frozen. Recall #B-203/204-1. CODE Unit #41FY98784. MANUFACTURER The American National Red Cross, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated September 24, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells; b) Platelets Pooled. Recall #B-205/206-1. CODE Unit Numbers: a) W111757; b) HP04176. MANUFACTURER Puget Sound Blood Center & Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated April 27, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been exposed to an individual with hepatitis A. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitate AHF; d) Recovered Plasma. Recall #B-207/210-1. CODE Unit #41FJ48012. MANUFACTURER The American National Red Cross, Birmingham, Alabama. RECALLED BY Manufacturer, by letters dated January 28, 2000, June 20 and 27, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama and Switzerland. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-211-1. CODE Unit #21KP08755 (two units). MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on July 13, 2000, and by letter dated July 26, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 double unit was distributed. REASON Blood products were labeled as having tested CMV antibody negative. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-212/213-1. CODE Unit #41LV13581. MANUFACTURER American Red Cross, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated September 17, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Methotrexate. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-215/216-1. CODE Unit Numbers: a) 41GQ77354, 41GG08959, 41GQ74215; b) 41GQ77354, 41GG08959, 41GQ74215. MANUFACTURER The American National Red Cross, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated September 1, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama, California, New York, Switzerland. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Platelets. Recall #B-217-1. CODE Unit #87-13404. MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan, by letter dated December 15, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who took the drug Zocar, within 12 hours of donation. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-218/219-1. CODE Unit Numbers: a) 03GT43980, 03GY14922, 03GY14927, 03LT46140, 03LT46148, 03LT46163; b) 03GY14922. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY American Red Cross Blood Services, Atlanta, Georgia, by telephone on June 30, 1999, and by letter dated July 22, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY a) 6 units; b) 1 unit distributed. REASON Blood products corresponded to six units of Platelets that were implicated in a transfusion reaction. ________ PRODUCT Source Plasma. Recall #B-221-1. CODE Unit Numbers: 99OWID2473, 99OWID3049, 99OWID3774. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated August 2, 1999. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 3 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Source Plasma. Recall #B-222-1. CODE 98OWIA4637, 98OWIA5348, 98OWIA6206, 98OWIA9297, 98OWIA9615, 98OWIB1414, 98OWIB2156. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated August 3, 1998. Firm-initiated recall complete. DISTRIBUTION Minnesota and Austria. QUANTITY 7 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Source Plasma. Recall #B-223-1. CODE Unit #00OWIA0521. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc, Hoover, Alabama, by letter dated February 10, 2000. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that may have compromised the sterility of the units. ________ PRODUCT Source Plasma. Recall #B-224-1. CODE Unit Numbers: Units 99OWIC9828, 99OWID0480, 99OWID1245, 99OWID2022, 99OWID2733, 99OWID3278 MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated August 6, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota and Austria. QUANTITY 6 units were distributed. REASON Blood products were collected from a donor who had been immunized with MMR vaccine, within four weeks of the donations. ________ PRODUCT Source Plasma. Recall #B-225-1. CODE Unit #98OWID3342. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated August 31, 1998. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was not asked any of the pre-donation donor screening questions. ________ PRODUCT Source Plasma. Recall #B-226-1. CODE Unit #99OWIB8782. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by letter dated May 27, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was not asked any of the pre-donation donor screening questions.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-145-1. CODE Unit #3446633. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by fax on June 20, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a Yellow Fever vaccine within two weeks of donation. ________ PRODUCT a) Antihemophilic Factor (Recombinant), Kogenate, b) Antihemophilic Factor (Recombinant) Helixate. Recall #B-163/164-1. CODE Lots Numbers: a) 670H076, 1670H071C; b) 670H071E. MANUFACTURER Bayer Corporation, Berkeley, California. RECALLED BY Manufacturer, by letter dated July 27, 2000, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Taiwan. QUANTITY a) 16,009 vials; b) 1,116 vials were distributed. REASON Product may fall below the labeled potency when stored at 25 degrees C. ________ PRODUCT Recovered Plasma. Recall #B-192-1. CODE Unit #15006-1226. MANUFACTURER Blood Systems, Inc., South Plains Blood Services, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated November 23, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Asacol. ________ PRODUCT Red Blood Cells. Recall #B-198-1. CODE Unit #7219622. MANUFACTURER Department of the Air Force, Malcolm Grow USAF Medical Center, Andrews AFB, Maryland. RECALLED BY Manufacturer, by fax on November 14, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product tested RPR positive and negative by confirmatory testing. ________ PRODUCT Red Blood Cells. Recall #B-199-1. CODE Unit #21KH41040. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on July 26, 2000, and by letter dated August 3, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells. Recall #B-232-1. CODE Unit numbers: 18GH61201, 18GH61216, 18GF28863. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by telephone on August 16, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 3 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Platelets. Recall #B-235-1. CODE Unit Numbers: 17KP77920, 17KP77925, 17KP77926, 17KP77927, 17KP77928, 17KP77930 through 17KP77939, 17KP77941, 17KP77942. MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated September 21, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota and Iowa. QUANTITY 17 units were distributed. REASON Blood products were collected in expired blood collection bags.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_________ PRODUCT Synchron LX ISE Reference Reagent, Part #467935, used in the measurement of electrolytes from patient samples. Recall #Z-1034-0. CODE Lot #M004170 EXP 31 OCT 01. MANUFACTURER Beckman Coulter, Inc., Carlsbad, California. RECALLED BY Beckman Coulter, Inc., Brea, California, by letter dated May 24, 2000. Firm-initiated field correction complete. DISTRIBUTION Alabama, Arkansas, California, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Washington state, Australia, Canada, Italy, Mexico, Switzerland, England, France Germany, Ireland, South Africa, Japan, Hong Kong, Taiwan, Sweden, Netherlands, Republic of Singapore, Spain, Puerto Rico. QUANTITY 789 units were distributed. REASON The C02 assay would not calibrate. ________ PRODUCT Vitros Eci Immunodiagnostic Estradiol Reagent Packs, Catalog #855 2360, for in vitro quantitative measurement of estradiol in human serum and plasma. Recall #Z-017-1. CODE Lot #134 EXP 07/03/00. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff, UK. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by E-mail and/or fax and by letter dated April 25, 2000, Firm-initiated recall ongoing. DISTRIBUTION Connecticut, Indiana, Michigan, New York, Ohio, Texas, Utah, Argentina, Australia, Brazil, Canada, Chile, Colombia, England, Germany, India, Italy, Japan, Mexico, Puerto Rico, Panama, Singapore, Spain and Venezuela. QUANTITY 938 kits were distributed. REASON A positive bias was observed on controls and patient samples when using the above product. ________ PRODUCT Vitros Chemistry Products Testosterone Reagent, Catalog #143-5205, for in-vitro quantitative measurement of testosterone in human serum and plasma. Recall #Z-021-1. CODE Lot Numbers: 90 EXP 4 May 2000 Previous EXP 15 Oct 2000, Lot 100, Revised EXP 17 May 2000, Previous EXP 18 Oct 2000. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, UK. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letter dated May 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Argentina, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. QUANTITY 960 packs were distributed. REASON Products were assigned the wrong expiration dates. EXP dates were too long. ________ PRODUCT Vitros Chemistry Products Vitamin B12 Reagent Pack, Catalog #145 3489, for in-vitro diagnostic use only for the quantitative measurement of vitamin B12 in human serum and plasma, to aid in the differential diagnosis of anemia. Recall #Z-022-1. CODE Lot Numbers 71 EXP 5/23/00 and Lot 80 EXP 8/26/00. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch Cardiff, UK. RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York, by letter dated February 21, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide, Argentina, Australia, Canada, England, France, Germany, Italy, Puerto Rico, Singapore and Spain. QUANTITY 778 units were distributed. REASON A positive bias was confirmed on patient samples. ________ PRODUCT Automated Slide Stainer (Dispenser), intended to stain samples collected to aid in the diagnosis of disease: a) Part #1362303; b) Part #1362304; c) Part #1362305. Recall #Z-023/025- 1. CODE a) Part Number 1362303: A dispenser that is filled by Ventana Medical Systems and is used in the production of 87 different products with unique catalog numbers. Each of these products are for single use only and have no expiration dating except for that which applies to the reagent in the dispenser. 114,782 units of 119 dispenser lots are affected. b) Part Number 1362304: An unfilled dispenser for customer use and is used in 62-65 other products. 8,167 units of 13 dispenser lots are affected. c) Part Number 1362305: A dispenser for light sensitive reagents. it contains 36 reagents which are for single use and bear expiration dates relevant to the reagent. 19, 181 units of 22 dispenser lots are affected. MANUFACTURER Ventana Medical Systems, Inc., Tucson, Arizona. RECALLED BY Manufacturer, by letter dated June 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Korea, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Panama, Philippines, Portugal, Scotland, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan ROC, Thailand, The Netherlands, Turkey, United Kingdom, Wales. QUANTITY 269,498 kits were distributed. REASON Leaking dispensers were attributed to the vent in the cap of the dispenser, the interface of the cap and the barrel or from the nozzle. _______ UPDATE Vitros Chemistry Products Testosterone Reagent Pack, Catalog #143 5205 (Ortho-Clinical Diagnostics, Inc., Rochester, New York), Recall #Z-920-0, which appeared in the September 20, 2000 Enforcement Report is a Class III recall.END OF ENFORCEMENT REPORT FOR NOVEMBER 8, 2000.
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