July 25, 2001 01-29RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: A) D-247-1, Children’s Benadryl Allergy & cold FASTMELT Tablets, Cherry flavored B) D-248-1, Benadryl Allergy Kapseals or Ultratab tablets packaged in a 48 count box and including a free, 10-count tablet sample of Benadryl Allergy & Sinus FASTMELT. C) D-246-1, Benadryl Allergy & Sinus FASTMELT, box of 20 tablets Note: It is the FASTMELT product only that is the focus of this recall action. Allergy & Sinus Fastmelt 10 Tablet Free Sample Inside (Recall # D-248-1) All lots; all configurations and all lots of Benadryl Allergy 48 count Ultratabs/Kapseals containing 10-count FASTMELT product REASON: Mislabeled; Phenylalanine amount is 4.6 mg per tablet/capsule but labeled to contain 1.2 mg MANUFACTURER: Shaklee Technica, Norman, OK RECALLED BY: Warner Lambert Consumer Group, Pfizer Inc. by letter on June 6, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 88403 cases (24 units/case); 2, 382,429 prof. Samples; 36,780 displays ______________________________ RECALL NUMBER, PRODUCT AND CODE: D-252-1, Levothyroxine Sodium Tablet 25 mcg. in bottles of 100's and 1000's. Lots - 029011A, 029011B, 029011D, 030011A, 031011A, 031011B D-253-1, Levothyroxine Sodium Tablets 50 mcg. in bottles of 100's and 1000's. CODES: Lots - 009040A, 009040B, 009040C, 025070A, 025070B, 025070C, 025070D, 026070A, 073090A, 073090B, 073090C, 073090D, 014100A, 001110A, 001110B, 002110A, 002110B, 002110C REASON: Stability; May not maintain potency through the expiration date. MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Inc., Charlotte, NC RECALLED BY: Vintage by letter on 3/21/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY Levothyroxine Sodium 0.025 mg. - 21,861 bottles were manufactured and distributed; Levothyroxine Sodium 0.050 mg - 18,718 bottles were manufactured and distributed. ______________________________ RECALL NUMBER, PRODUCT AND CODE: D-254-1, (Rx) Levothyroxine Sodium, USP Tablets, 25 mcg (0.025mg), 100 and 1,000 tablets Lots 083100B, 083100C, 018060A, 018060B, 018060C, 018060D D-255-1, (Rx) Levothyroxine Sodium, USP Tablets, 50 mcg (0.05mg), 100 and 1,000 tablets Lots 089089I, 089089J, 011030A, 012030A, 012030B, 012030C, 010040A, 119050A, 120050A, 120050B, 120050C, 120050D, 120050E, 014080A, 015080A, 015080B D-256-1, (Rx) Levothyroxine Sodium, USP Tablets, 75 mcg (0.075mg), 100 and 1,000 tablets - Lots 148080A, 104080A, 104080B, 104080C, 107070A, 019060A, 019060B, 019060C, 019060D, 019060E, 019060F, 121050A, 121050B, 121050C, 012040A, 012040B, 012040C, 011040A, 011040B, 051090A, 052090A, 052090B, 052090C, 093090A, 093090B, 093090C, 093090D, 094090A, 094090B, 094090C, 094090D, 085100A, 085100B, 085100C, 116059A, 116059B REASON: Stability data does not support expiry date MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, charlotte, NC RECALLED BY: Recalling firm sent a recall notice on 3/7/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 16,996 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-257-1, Levothyroxine Sodium 0.075 mg. Rx Tablets, USP under the QT, VPI and URL labels. The product is packaged in 100 and 1000 tablet bottles. Code: Lots 021129A, 021129B, 022129A, 022129B, 022129C, 022129D, 010030A, 010030B, 010030C, 010030D REASON: Stability data does not support expiry date MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Inc., Charlotte, NC RECALLED BY: Vintage by letter on 1/29/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY 36, 578 bottles ______________________________ RECALL NUMBER, PRODUCT AND CODE: D-258-1, Levothyroxine Sodium 0.025 mg - Lots 013030A, 013030B, 013030C D-259-1, Levothyroxine Sodium 0.075 mg - Lots 116059A, 116059B REASON: The product may not maintain potency through the expiry date MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Inc., Charlotte, NC RECALLED BY: Vintage by letter on 12/18/00 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Levothyroxine Sodium 0.025 mg. - 22,186 bottles were manufactured and distributed; Levothyroxine Sodium 0.075 mg. - 2,910 bottles were manufactured and distributed. ______________________________ RECALL NUMBER, PRODUCT AND CODE: D-251-1, Q Tuss Tablets in bottles of 100's and 500's. The product is under the Zenith Goldline, URL, QT, VPI and URL label. Lots - 010079A, 010079B, 010079C, 097089A, 098089A, 098089B, 098089C, 098089D, 098089E, 098089F, 099089A, 099089B, 136039A, 136039B, 136039C, 136039D, 008119A, 010119A, 011119A, 011119B, 011119C, 011119D, 011119E, 011119F, 009119A, 009119B, 009119C, 009119D, 009119E, 009119F, 011079A, 011079B, 011079C, 011079D, 011079E, 013090A, 013090B, 013090C, 100020C, 100020D, 012090A, 012090B REASON: Super-Potency (Scopolamine) MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Charlotte, NC RECALLED BY: Vintage by letter on 3/21/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Q-Tuss Tablets - 110,538 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-250-1, Oxycodone HCL/Acetaminophen 5/500 mg Rx Capsules under the Vintage and Qualitest labels. The product is packaged in 100 capsule bottles. Code: Lot 126060A and 126060B REASON: Dissolution failure (Acetaminophen) MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Inc., Charlotte, NC RECALLED BY: Vintage by letter on 2/13/01 DISTRIBUTION: Nationwide FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 9,425 bottlesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________ RECALL NUMBER,PRODUCT AND CODE: B-1482-1, Red Blood Cells, units 2204298, 2204299 B-1483-1, Recovered Plasma, units 2204298, 2204299 REASON: Blood products, collected from donors with a history of hepatitis or yellow jaundice due to mononucleosis, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria, OH RECALLED BY: The recalling firm notified three consignees, located in Ohio and Florida, by letters dated March 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and FL QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1484-1, Red Blood Cells, units 2121539, 2220589, 2150878, 2150958, 2121608 B-1485-1, Platelets, Pheresis Leukoreduced, unit 2301361 B-1486-1, Fresh Frozen Plasma, units 2150958, 2121608 B-1487-1, Plasma, Cryo-reduced, unit 2220589 B-1488-1, Cryoprecipitated AHF, units 2220589, 2150878 REASON: Blood products, collected from donors who were not properly screened for high risk behaviors, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria, OH RECALLED BY: The recalling firm notified consignees, located in Ohio and Maryland, by letters dated March 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and MD QUANTITY: 11 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1489-1, Red Blood Cells, Leukocyte Reduced, unit 0320837 REASON: Blood product, collected from a donor who had self-administered the donor health history questions, was distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas, Kansas City, MO RECALLED BY: The recalling firm notified a Kansas consignee by telephone on December 10, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: KA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1492-1, Red Blood Cells, units 42FX02312, 42FX02316, 42FX02319, 42FX02322, 42FX02324, 42FX02327, 42FX02328 REASON: Blood products, collected from a donor whose arm preparation had not been appropriately performed prior to venipuncture, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH RECALLED BY: The recalling firm notified Ohio consignees by telephone on 2/13/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 7 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1493-1, Red Blood Cells, unit 42K28860 B-1494-1, Platelets, unit 42K28860 REASON: Blood products, collected from a donor who reported having lived in an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH RECALLED BY: The recalling firm notified Ohio consignee by letter dated April 11, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1495-1, Platelets, Pheresis, unit 42KP03951 REASON: Blood product, which had a low platelet count, was distributed in interstate commerce. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH RECALLED BY: The recalling firm notified the ARC, Great Lakes Region, Lansing, MI of the recall by letter dated February 28, 2001. The Great Lakes region notified a Michigan consignee by letter on March 6, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1496-1, Platelets, Pheresis, Leukocyte Reduced, units 6931581, 6931561 REASON: Blood products, which did not meet the specifications of a leukoreduced product, were distributed labeled as leukroreduced. MANUFACTURER/RECALLING FIRM: Central Indiana Regional Blood Center, Inc., Indianapolis, IN RECALLED BY: The recalling firm notified Indiana consignees by telephone on March 13, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1516-1, Source Plasma, unit 38657702 REASON: Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. MANUFACTURER/RECALLING FIRM: Nabi Biomedical Center, Corpus Christi, TX RECALLED BY: The recalling firm notified the California consignee by facsimile on September 7, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1548-1, Corneas, OBO102017 (Left and Right) REASON: Corneas that were collected from a donor who tested repeatedly reactive for HBsAg, by another tissue procurement organization, were distributed. MANUFACTURER/RECALLING FIRM: Medical Eye Bank Maryland, Baltimore, MD RECALLED BY: The recalling firm notified physicians, by telephone on March 15, 2001 and by letters dated March 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD and Washington, D.C. QUANTITY: 1 set of corneas (left and right) _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1554-1, Red Blood Cells, units 04LE18901, 04G00238 B-1555-1, Platelets, units 04LE18901, 04G00238 B-1556-1, Fresh Frozen Plasma, unit 04G00238 B-1557-1, Recovered Plasma, unit 04LE18901 REASON: Blood products, collected from a donor taking the drug Methotrexate, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm notified consignees, by letters dated November 24, 2000. Non-responding consignees were sent a second letter on January 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA and VT QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1558-1, Red Blood Cells, Leukoreduced, unit 04KW85761 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm notified the consignees by letter dated November 21, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1559-1, Red Blood Cells, Leukoreduced, unit 01LH38531 REASON: Blood product, collected in a manner that compromises the sterility of the unit, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY RECALLED BY: The recalling firm notified the consignee by telephone on January 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1560-1, Red Blood Cells, units 13FN46669, 13FL94655, 13FC01819 B-1561-1, Red Blood Cells, Leukoreduced, units 13FJ51632, 13FG84442, 13FG84438 REASON: Blood products, corresponding to a unit of pooled Platelets, that were implicated in a transfusion reaction, and found to be contaminated with Staphylococcus, Coagulase negative, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southeastern Region, Detroit, MI RECALLED BY: The recalling firm notified the consignees by telephone on October 29, 1999, and by letters on November 11 or 12, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1568-1, Red Blood Cells Leukoreduced, unit 3821485 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm notified the consignee by facsimile dated July 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1569-1, Red Blood Cells, units KY74075, KQ88274 B-1570-1, Recovered Plasma, units KY74075, KQ88274 REASON: Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. MANUFACTURER Blood Centers of the Pacific, Peninsula South Bay Center, Burlingame CA RECALLED BY: Blood Centers of the Pacific, San Francisco, CA, by letters dated July 12, 1999 or July 27, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and Switzerland QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1571-1, Source Leukocytes, unit 3941253 REASON: Blood product, collected from a donor whose suitability was not adequately determined, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm notified the consignee by facsimile on October 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NJ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1592-1, Red Blood Cells, unit 38K83158 B-1593-1, Platelets, unit 38K83158 REASON: Blood products, collected from a donor with Erythropoietic Porphyria, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Fort Wayne, IN RECALLED BY: The recalling firm notified the consignees by letter on March 7, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1612-1, Source Plasma, units 28284512, 29963829 REASON: Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. MANUFACTURER/RECALLING FIRM: Nabi Biomedical Center, Dallas, TX RECALLED BY: The recalling firm notified the California by facsimile on June 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1618-1, Red Blood Cells, unit 93-63862 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the consignee by letter dated December 16, 1999, FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1623-1, Red Blood Cells, unit 92-59080 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the consignee by letter dated September 8, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1619-1, Red Blood Cells, unit 94-45725 B-1620-1, Red Blood Cells, Irradiated, unit 90-11400 B-1621-1, Platelets, unit 94-45725 B-1622-1, Recovered Plasma, units 94-45725, 90-11400 REASON: Blood products, collected from a donor who was born in and traveled to an area considered to be high risk for anti-HIV-1/2, Group O, were distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified consignees, by letters or facsimile dated October 14, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: KY, TN and CA QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1624-1, Red Blood Cells, Unit 93-56453 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the consignee by letter dated March 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1625-1, Red Blood Cells, Leukoreduced, unit 94-67515 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the consignee by letter dated April 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1626-1, Red Blood Cells, Leukoreduced, unit 94-68398 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the consignee by letter dated May 23, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1632-1, Red Blood Cells, unit 6886092 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Center of New Jersey, Inc., East Orange, NJ RECALLED BY: The recalling firm notified the consignee by letter dated January 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NJ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1643-1, Red Blood Cells, unit 19233-4761 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER: United Blood Services, Reno, NV RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated July 6, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1644-1, Red Blood Cells, units K45135, K42713, K34902, K31603 B-1645-1, Platelets, unit K45135 B-1646-1, Fresh Frozen Plasma, units K42713, K34902 B-1647-1, Frozen Plasma, unit K31603 B-1648-1, Cryoprecipitate, unit K31603 B-1649-1, Recovered Plasma, unit K45135 REASON: Blood products, collected from a donor who provided post donation information involving having engaged in high risk behaviors, were distributed. MANUFACTURER/RECALLING FIRM: Blood Centers of the Pacific, Burlingame CA RECALLED BY: Blood Centers of the Pacific, San Francisco, CA, by letters dated September 24, 1999 or November 18, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 10 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1562-1, Recovered Plasma, units 13FL94655, 13FC01819, 13FJ51632, 13FG84442, 13FG84438 REASON: Blood products, corresponding to a unit of pooled Platelets, that were implicated in a transfusion reaction, and found to be contaminated with Staphylococcus, Coagulase negative, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southeastern Region, Detroit, MI RECALLED BY: The recalling firm notified consignees by telephone on October 29, 1999, and by letters on November 11 or 12, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 5 _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1376-1, Red Blood Cells, Leukoreduced, Irradiated, units FR24643, FR24495, FR24580, FR24683, FR24592 REASON: Blood products, labeled with extended expiration dates, were distributed. MANUFACTURER/RECALLING FIRM: Delta Blood Bank, Stockton, CA RECALLED BY: The recalling firm notified consignee by telephone and facsimile on December 30, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1481-1, Platelets, units 2121560, 2111901, 2206052, 2221502 REASON: Blood products, prepared from four units of Whole Blood with extended collection times, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc, Elyria, OH 44035 RECALLED BY: The recalling firm notified Ohio consignees by letters dated March 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1490-1, Red Blood Cells, unit 1284980 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas, Kansas City, MO RECALLED BY: The recalling firm notified the Missouri consignee by letter dated July 6, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1491-1, Red Blood Cells, Leukocytes Removed, unit 0340082 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas, Kansas City, MO RECALLED BY: The recalling firm notified the consignee by letter dated July 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1567-1, Red Blood Cells, Leukoreduced, units 12449-4200, 12450-3676 REASON: Blood products, which may not meet the parameter for red blood cell recovery, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Albuquerque, NM, RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated March 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and NM QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1573-1, Platelets, unit G00613 REASON: Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. MANUFACTURER/RECALLING FIRM: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI RECALLED BY: The recalling firm notified the consignee by telephone on July 10, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1575-1, Source Plasma, unit LA-48255 REASON: Blood product, collected from a donor whose arm inspection and skin disease status had not been documented, was distributed. MANUFACTURER: Pyramid Biological Corporation, Van Nuys, CA. RECALLED BY: The recalling firm, notified the consignee by facsimile dated October 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1574-1, Source Plasma, unit LP-27408 REASON: Blood product, collected from a donor whose arm inspection and skin disease status had not been documented, was distributed. MANUFACTURER: Pyramid Biological Corporation, Las Vegas, NV RECALLED BY: The recalling firm, notified the consignee by facsimile dated August 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NJ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1576-1, Source Plasma, unit G-53655-165 REASON: Blood product, collected from a donor whose arm inspection and skin disease status had not been documented, was distributed. MANUFACTURER: Pyramid Biological Corporation, Las Vegas, NV RECALLED BY: The recalling firm, notified the consignee by facsimile dated July 17, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1603-1, Source Plasma, unit LP-25981 REASON: Blood product, collected from a donor whose health history screening was inadequately performed, was distributed. MANUFACTURER: Pyramid Biological Corporation, Las Vegas, NV RECALLED BY: Pyramid Biological Corporation, Van Nuys, CA, notified the consignee located in Austria by fax on August 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1630-1, Red Blood Cells, unit 95-14414 B-1631-1, Recovered Plasma, unit 95-14414 REASON: Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified a consignee by letter dated August 6, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1629-1, Red Blood Cells, Leukoreduced, Irradiated, units 93-81920, 90-49487, 93-81838 REASON: Blood products, labeled with extended expiration dates, were distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified Tennessee consignees by telephone on March 25, 2000, and by letters dated April 5, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1627-1, Red Blood Cells, Leukoreduced, Irradiated, unit 93-75308 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the Tennessee consignee by telephone on November 8, 1999, and by letter dated January 12, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1628-1, Whole Blood, Autologous, unit 9037884 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the Tennessee consignee, by telephone on July 21, 1999, and by letter dated July 29, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-579-1 - X-Ray Generator/Control; KXO-30R Z-580-1 - X-Ray Generator/Control; KXO-50F Z-581-1 - X-Ray Generator/Control; KXO-80N REASON: Noncompliance with 21 CFR 1020.31(a)(2) because exposure non-termination can occur as a result of tube arcing MANUFACTURER/RECALLING FIRM: Toshiba American Medical System Tustin, CA RECALLED BY: By letter dated July 19,2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 439 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-623-1 - Luscent Anchors, Model LUC-K1; Z-624-1 - Luscent Anchors, Model LUC-4. REASON: Anchors, for dental restoration, show a reduced light (UV) transmission at the lower tapered end due to incomplete polymerization of surrounding light cured material. MANUFACTURER/RECALLING FIRM: Dentatus USA, Ltd., New York, NY RECALLED BY: By letter dated 12/28/99 and by telephone. FIRM INITIATED RECALL: Terminated. DISTRIBUTION: 1 distributor, Henry Schein in Melville, NY. Schein further distributed the product to 4 distribution centers in Grapevine, Texas (90 units); Denver, Pennsylvania (110 units); Sparks, Nevada (110 units) and Indianapolis, Indiana (190). QUANTITY: 602. _______________________________ PRODUCT, RECALL NUMBER, AND CODE: LIFEPAK? 500 Automated External Defibrillator Z-694-1 - Part No. D3005400-000004; Z-695-1 - Part No. K3005400-000005; Z-696-1 - Part No. U3005400-000004; Z-697-1 - Part No. U3005400-000005; Z-698-1 - Part No. 30111790-00012; Z-699-1 - Part No. D3011790-000011; and Z-700-1 - Part No. D3011890-000012. Lot/Serial Nos. 11699545, 11209055, 11674082, 11705151, 11705168, 11715467, 11891902, 11926985, 11926986, 11930544, 12009374, 12169174, 12169995, 12176146, 12198396, 12198400, 12201791, 12201793, 12222417, 12222433, 12222434, 12222435, 12349533, 12405530, 12528800, and 12528801; REASON: Mis-configured devices will not auto-analyze. MANUFACTURER/RECALLING FIRM: Medtronic Physio-Control Corp., Redmond, WA RECALLED BY: Service representative visit beginning August 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Units were distributed to first responders - medical facilities, fire departments, ambulance companies nationwide. QUANTITY: 26 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-701-1, LIFEPAK? 500 Automated External Defibrillator, Lot/Serial Numbers: 12778268, 12778270-12778275, 12778284, 12778285, 12778296-12778331, 12778403-12778420, 12778422- 12778432, 12778749-12778755, and 12778761-12778763; REASON: Devices will not auto-analyze MANUFACTURER/RECALLING FIRM: Medtronic Physio-Control Corp., Redmond, WA RECALLED BY: Service representative visit and letter dated May 24, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide. QUANTITY: 83 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-702-1, FlexiLab® versions 5.23, Released 2/22/00; REASON: This software version could file incorrect patient data to the Hospital Information System. MANUFACTURER/RECALLING FIRM: SUNQUEST Information Systems, Inc., Tucson, AZ RECALLED BY: Product Safety Notice, PSN-01-L14 on May 1, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, UK, and Denmark. QUANTITY: 120 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-707-1, Roche HbA1c Calibrator, Catalog No. 07555664/47110, Lot No. 61130001. REASON: Use of the referenced product may result in negatively biased results. MANUFACTURER/RECALLING FIRM: Roche Diagnostics Corp., Indianapolis, IN RECALLED BY: Urgent Product Removal letter dated 06/22/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 1,320 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-709-1, H-TRONplus V100 Insulin Infusion Pump, All Serial Numbers REASON: Misbranded in that there are labeling claims of the H-TRONplus V100 Infusion Pump being waterproof; however, this claim was not clear. MANUFACTURER/RECALLING FIRM: Disetronic Medical Systems, St. Paul, MN RECALLED BY: By letter dated March 14, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Estimated 30,000 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-710-1, Arthotek Disposable Infusion Pump, Model No. B074338, Catalog No. 909995. All lots. REASON: Devices may not deliver the prescribed dose of drug. MANUFACTURER/RECALLING FIRM: Arthrotek, A Biomet, Inc. company, Warsaw, IN RECALLED BY: Recalling firm contacted distributors, other direct accounts, and distributor consignees by facsimile on June 20 or June 21, 2001. On June 22, 2001, a recall letter was sent to distributor and user by registered/certified mail. FIRM INITIATED RECALL: Complete DISTRIBUTION: U.S. and Canada QUANTITY: 841 devicesRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-695-1, Atlas Cable with an Integral Crimp, Product code: 826-213 Lots: 07089, 07129, 07130, 07131, 07132 The device is a temporary implant for use in orthopedic and cardiovascular surgery. The system is intended to help provide temporary stabilization, augment the development of solid bony fusion and/or aid in the repair of bone fractures. REASON: The inner packaging of the product is mislabeled as stainless steel, rather than titanium. MANUFACTURER/RECALLING FIRM: Medtronic Sofamor Danek, Memphis, TN RECALLED BY: By sales representatives starting 4/4/2001. By letter on 5/4/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: US, Canada, Australia, Germany, and South Africa QUANTITY: 322 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-708-1, Vitros Calcium Slides, Lot No. 0313-0287-6531, 0313-0287-6582, 0313-0287-6583, 0313-0287-6743, 0313-0287-6749, 0313-0287-7565, 0313-0287-7598, 0313-0287-7611, 0313-0287-7634, 0313-0287-7679, 0313-0287-7685, 0313-0287-8130, 0313-0287-8184, 0313-0287-8278, 0313-0287-8300, 0313-0287-8311; REASON: Calcium results from plasma samples are negatively biased by approximately 1.5- 3.0 mg/dL (0.37-0.75 mmol/L) when compared to serum. MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY RECALLED BY: Customers were notified via letters beginning on 5/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Brazil, Chile, France, Germany, Italy and the UK Federal: 15 military and VA consignees (gov't contract V797P-6565A) QUANTITY: 6,173 cartonsRECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________________________________ RECALL NUMBER, PRODUCT AND CODE: V-353-1 through V-370-1, Chicken feed products: Recall # Tag # Product V-353-1 587 B. Challenger Scratch Feed V-354-1 588 B. 18% Gamebird Conditioner V-355-1 2060 B. Kickin' Chicken Premium Game Cock Feed V-356-1 2066 B. Kickin' Chicken Premium Gamebird 16% V-357-1 586 B. Scratch Grain V-358-1 2051 B. Pit Performer 17% V-359-1 575 B. Classic Yard Feed V-360-1 576 Eliminator Maintainer V-361-1 578 Eliminator Conditioner V-362-1 586 Producer Scratch Grain V-363-1 4587 Producer 12% Gamebird Yard Feed V-364-1 2065 Cleveland Trophy Cock Feed V-365-1 80181AAA Consolidated Hen Scratch V-366-1 2051 B&B Maintenance 12 V-367-1 2052 B&B Conditioner 14 V-368-1 2050 B&B Scratch 10 V-369-1 4590 Kingsport Original Prater Mix V-370-1 2062 PC 10 (unlabeled bags) ALL CODES The "B" indicates that the Burkmann Feeds brand name is listed on the tag labels. The suspect products are also bagged and distributed under the following private labels: Producer Feeds, Louisville, Kentucky Kingsport Milling, Kingsport, Tennessee Consolidated Nutrition, L.C., Omaha, Nebraska B&B Feeds, Knoxville, Tennessee Eagle Roller Mill Co., Inc., Shelby, North Carolina Central Farm Supply of Kentucky, Inc., Louisville, Kentucky REASON: The chicken feed products may contain proteins derived from mammalian tissues. The products are not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: Burkmann Feeds, London, Kentucky RECALLED BY: On May 5, 2001, the firm mailed recall letters with attached BSE sticker-labels to all customers outside the state of Kentucky. The recall notices were hand- delivered to customers within the state of Kentucky by Burkmann's Sales Representatives. Customers were asked to complete and return a recall response form that was included with each letter documenting the numbers of bags and varieties of products for which the customers affixed the BSE sticker-labels. The firm expanded their recall on May 10, 2001, and mailed recall letters with BSE labels and response forms to the affected customers. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: KY, GA, NC, TN, VA QUANTITY: 933 tons _______________________________ RECALL NUMBER, PRODUCT AND CODE: V-377-1, Renner’s brand 45% meat and bone meal, packed in 100 pound bags. REASON: The product contained protein material derived from bovine mammalian tissues; however, the bags are not labeled with the required BSE cautionary statement. MANUFACTURER/RECALLING FIRM: F. W. Renner & Sons, Inc., Canton, Ohio RECALLED BY: The recalling firm contacted the consignees by telephone on June 19, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 2,500 lbs _______________________________ RECALL NUMBER, PRODUCT AND CODE: V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in bulk, as follows: V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3% crude fat, and 3.5% crude fiber. V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3% crude fat, and 3.5% crude fiber. V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3% crude fat, and 3.5% crude fiber. V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3% crude fat, and 3.5% crude fiber. V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein, 3.5% crude fat, and 4% crude fiber. V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein, 3% crude fat, and 5% crude fiber. V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude protein, 3% crude fat, and 5.5% crude fiber. MANFACTURER: Esbenshade Mills, Mount Joy, PA RECALLED BY: On 5/24/01, the manufacturer notified their customers of the labeling requirement via letter. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: None. The product turn over is two weeks or less. END OF ENFORCEMENT REPORT FOR July 25, 2001.####
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