October 1, 1997 97-40 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Veragel 1:1 Purified Aloe Vera Leaf Water Soluble Extract, in 55 blue gallon polyethylene drums. Recall #F-822-7. CODE Lot #6-1781, Product Code 21501-000, No expiration date. MANUFACTURER Madis Botanicals, South Hackensack, New Jersey. RECALLED BY Manufacturer, by telephone on November 13, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 57 drums were distributed; firm estimates none remains on the market. REASON The product is contaminated with Enterobacter gergoviae, an opportunistic pathogen. _______________ PRODUCT Blue-Marlin Frozen Loins, individually wrapped in plastic and packed into a cardboard case. Recall #F-824-7. CODE Lot #20140. MANUFACTURER Costa Pesca, Quito, Ecuador (shipper/processor). RECALLED BY Fresh Fish Inc., Miami, Florida, by letter faxed on June 10, 1997. Firm-initiated recall complete. DISTRIBUTION Florida and Maryland. QUANTITY 1,303 pounds were distributed. REASON Product was associated with scombroid poisoning and contained high histamine levels. ____________ PRODUCT "The" Daily Multiple Tablets, shipped to the repacker in a bulk fiber drum. Recall #F-825-7. CODE Bulk drum: lot #960135; Unit bottle: lot #C96008. MANUFACTURER Bactolac Pharmaceuticals, Inc., Westbury, New York. RECALLED BY Manufacturer, by letter mailed on August 15, 1996, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY Approximately 60,000 tablets were distributed; firm estimates none remains on the market. REASON Product is subpotent in folic acid. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Tatum's and Country Hearth brands, Old Time Biscuits, made with buttermilk, net weight 8 ounces. Recall #F-826-7. CODE Pull date of 07/07/97 on bag. MANUFACTURER Tatum Bakers, Birmingham, Alabama. RECALLED BY Manufacturer, by visit. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 3,260 packages were distributed. Firm estimates none remains on the market. REASON Product is unfit for food due to the presence of aluminum fragments. ______________ PRODUCT Cashews under the Thrifty brand and D&W brand: a) Whole Cashews, 2-1/4 ounces; b) Cashews (broken kernels), 8 ounces; c) Salted Cashews, 2-3/4 ounces. Recall #F-827/829-7. CODE All product with expiration date of 12/97 or earlier. MANUFACTURER Thrift Products Company, Kentwood, Michigan. RECALLED BY Manufacturer, by telephone on June 9, 1997, followed by visit on June 10 and 11, 1997, and by press releases on June 9 and 10, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY Approximately 7,500 bags were distributed. REASON The products' ingredient statement does not list the source of the oil used for roasting. -2-_______________ PRODUCT Minute Maid Orange Juice packaged in 9-packs of 8.45 ounce (250 ml.) aseptic drink box containers. Unit count per case is 27. Recall #F-832-7. CODE Lot number: Package: MAR0698GF Case: XX:XX MAR0698 G20581D. MANUFACTURER The Minute Maid Company, Geneva, Ohio. RECALLED BY The Minute Maid Company, Houston, Texas, by telephone on September 12, 1997, followed by visit. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, New York, Ohio, Alabama, Mississippi. QUANTITY 1,383 cases were distributed. REASON Product is contaminated with yeast. _______________ UPDATE Recall #F-812-7, Red Sugar Cake Decoration, which appeared in the September 24, 1997, Enforcement Report is being amended to NOT INCLUDE the Betty Crocker 1 ounce product. The Kroger Brand Red Sugar Cake Decoration is correctly included under Recall #F-812-7. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============ _______________ PRODUCT Prograf Tacrolimus Capsules, 1 mg, in bottles of 100, Rx oral drug indicated for the prophylaxis of organ rejection in patients receiving allogenic liver transplants. Recall #D-276-7. CODE Lot 1C3062B EXP 4/30/99. MANUFACTURER Fujisawa Ireland Ltd., Republic of Ireland. RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by letters dated September 3 and 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 6,890 bottles were distributed; firm estimated that 25-30% of product remained on market at time of recall initiation. REASON Mislabeling -- At least one bottle labeled to contain 1 mg capsules actually contained 5 mg capsules. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Gentamicin Sulfate Injection, USP, 40 mg/mL, in 20 ml multiple dose vials, under the following labels: Steris, Rugby, Goldline (Zenith on label). Recall #D-277-7. CODE Lot #95K550. -3-MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona. RECALLED BY Manufacturer, by letter on March 31, 1997. Firm-initiated. DISTRIBUTION Nationwide. QUANTITY 19,000 vials were distributed. REASON White precipitate in product (preservatives). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Platelets. Recall #B-1389-7. CODE Unit #16337-9672. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Manufacturer, by letter dated April 8, 1997. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Red Blood Cells that was reported as clotted. _______________ PRODUCT Allergenic Extract and Allergenic Treatment Sets. Recall #B-1412-7. CODE Lot # 648304, 653265, 663176, 666156, 668804, 668925, 668926, 670458, 671334, 678222, 678223, 678224, 678225, 678226, 678227, 678228, 678229, 678230, 678231, 678232, 678233, 678234, 678235, 678236, 678237, 678238, 678239, 678240, 678241, 692263, 693755. MANUFACTURER ALK Laboratories, Berkeley, California. RECALLED BY Manufacturer, by letter on August 16 and 27, 1997, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 31 lots. REASON Lack of assurance that products met sterility testing requirements prior to release. _______________ PRODUCT Platelets, Pheresis. Recall #B-1465. CODE Unit numbers: 16333-9425 and 16333-9430, MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Manufacturer, by letter dated October 23, 1996. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 2 units were distributed. REASON Blood products may have been labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-1468-7. CODE Units 49FJ53975, 49FJ55367, 49FM26720. -4-MANUFACTURER American National Red Cross, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letters dated July 1, 1997, and August 4, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma and Texas. QUANTITY 3 units were 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) Fresh Frozen Plasma. Recall #B-1472/1473-7. CODE Unit 29271-0984. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on May 29, 1997, and by letter dated July 8, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1474/1475-7. CODE Unit numbers: a) 10005367, 13000623, 31006566, 31006572; b) 31006566, 31006572. MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc, Tyler, Texas. RECALLED BY Manufacturer, by telephone on March 19, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY a) 4 units; b) 2 units were distributed. REASON Blood products tested repeatedly reactive for the Hepatitis B Surface Antigen (HBsAg), were distributed. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1492/1493-7. CODE Unit numbers: a) 10161-2218 and 10158-5733; b) 10156-1459, 10161-2218, 10158-5733. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated July 5, 1996, and December 10, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona and California. QUANTITY a) 2 units; b) 3 units were distributed. -5-REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1. _______________ PRODUCT Platelets. Recall #B-1494-7. CODE Unit #10525-2279. MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona. RECALLED BY Manufacturer, by telephone on February 28, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT Red Blood Cells. Recall #B-1496-7. CODE Unit #M96019058. MANUFACTURER United Blood Services, Ventura, California. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 20, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that could compromise the sterility of the product. _______________ PRODUCT Red Blood Cells. Recall #B-1497-7. CODE Unit #4661234. MANUFACTURER Naval Hospital, Groton, Connecticut. RECALLED BY Manufacturer, by telephone on August 28, 1997. Firm-initiated recall complete. DISTRIBUTION Haiti. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ===== _______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF. Recall #B-1286/1287-7. CODE Unit 21045-1515. MANUFACTURER United Blood Services, Fargo, North Dakota. RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter dated July 25, 1997. Firm-initiated recall complete. DISTRIBUTION North Dakota, Louisiana. QUANTITY 1 unit of each component was distributed. -6-REASON Blood products, which tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc. _______________ PRODUCT Recovered Plasma, Frozen. Recall #B-1461-7. CODE 25FS25282, 25FS25283, 25FS25284, 25FS25286, 25FS25287, 25FS25285, 25FS25288, 25FS25289, 25FS25291, 25FS25292, 25FS25293, 25FS25294, 25FS25295, 25FS25296, 25FS25297, 25FS25298, 25FS25299, 25FS25300, 25FS25301, 25FS25302, 25FS25303, 25FS25304, 25FS25306, 25FS25307, 25FS25308, 25FS25309, 25FS25310. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by E-mail and by fax on June 28, 1996. Firm-initiated recall complete. DISTRIBUTION California and Switzerland. QUANTITY 27 units were distributed. REASON Blood product was prepared from Whole Blood which may have reached unacceptable temperature during shipment. _______________ PRODUCT Red Blood Cells. Recall #B-1477-7. CODE Unit #10239-8348. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 13, 1994. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Platelets. Recall #B-1478-7. CODE Unit #10524-3527. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 28, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time and designated as a "difficult collection." _______________ PRODUCT Red Blood Cells. Recall #B-1479-7. -7-CODE Unit numbers: 10521-6637, 10521-6636, 10521-6635. MANUFACTURER United Blood Services, Scottsdale, Arizona RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 22, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 3 units were distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT Platelets. Recall #B-1480-7. CODE Unit numbers: 10238-3924, 10238-3920, 10238-3926, 10238-2741, 10238-2737, 10238-2739, 10238-4953, 10238-3928, 10238-3929, 10238-4792. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated August 22, 1994. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 10 units were distributed. REASON Blood products were shipped at an unacceptable temperature. _______________ PRODUCT Red Blood Cells. Recall #B-1495-7. CODE Unit numbers: 36247-0348, 36247-0134, 36247-0132. MANUFACTURER United Blood Services, Ventura, California. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 1, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON Blood products may have been stored at an unacceptable temperature. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ========== _______________ PRODUCT Solar 8000 Bedside Patient Monitor. Recall #Z-908-7. CODE Serial numbers beginning with B7, C7, D7, E7, FAll monitors manufactured between February 1, 1997 and July 10, 1997, with s7 or G7. MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by letter on August 15, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international.. QUANTITY 1,769 units were distributed. -8-REASON The speaker of the monitor may fail to audibly alarm due to the inappropriate length of the speaker lead wire. _______________ PRODUCT Lead Aprons, Collars, and Gonadal Shields. Recall #Z-912/914-7. CODE Products received from vendor between 5/97 and 7/97. No lot number or catalog number. MANUFACTURER Burlington Medical, Inc., Newport News, Virginia. RECALLED BY Manufacturer, by letter on July 15, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The radiation protection devices contain lead contaminated with small amounts of radioactive substances. _______________ PRODUCT Ultra-Flex Adult Anesthesia Breathing Circuits: 1. Product No. 51213F-6154 2. Product No. 5613B-61 3. Product No. 5613F-61 4. Product No. 5613F-80 5. Product No. 5753B-61 6. Product No. 5753F-10021 7. Product No. 61453B-8015X 8. Product No. 6753F-13621 9. Product No. 8613B-164 10. Product No. 8613B-84X 11. Product No. 8613F-13633 12. Product No. 8613F-164E 13. Product No. 8613F-61 14. Product No. 8613F-6121 15. Product No. 8613F-80 16. Product No. 8613F-84 17. Product No. 8613F-8433 18. Product No. 8752B-84X 19. Product No. 8753B-61 20. Product No. 8753F-104 21. Product No. 8753F-231 22. Product No. 8753F-248 23. Product No. 8753F-249 24. Product No. 8753F-61 25. Product No. 90337 26. Product No. 90358 27. Product No. Q5753F-28B31. Recall #Z-915/941-7. CODE Lot numbers: 1. 1947E7 2. 0236F7, 1948E7 -9- 3. 0237F7, 1337E7 4. 1238F7 5. 0101F7 6. 2296E7 7. 0680F7 8. 2058E7 9. 0586F7, 1341E7 10. 1139E7, 0243F7, 0213E7, 1205F7 11. 0101F7, 2300E7, 1728E7 12. 1342E7 13. 0244F7, 1952E7, 2158E7 14. 0587F7 15. 1037F7, 1343E7, 1953E7 16. 1282F7 17. 1212E7 18. 0504F7 19. 0505F7, 1603E7 20. 2061E7, 0104F7 21. 0105F7 22. 0247F7 23. 2062E7, 0106F7, 1346E7, 0248F7 24. 0250F7, 2041E7 25. 1734E7 26. 2042E7 27. 0002F7. MANUFACTURER King Systems Corporation, Noblesville, Indiana. RECALLED BY Manufacturer, by fax on August 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Singapore. QUANTITY 328 cases were distributed. REASON The expandable tube is breaking around the circumference of the tube. SAFETY ALERTS: ============================================== _______________ PRODUCT Autopheresis-C Plasmapheresis System. Safety Alert #N-028-7. CODE Model A-200, Model A-201, Model A-401. MANUFACTURER Baxter Healthcare Corporation, Largo, Florida. ALERTED BY Baxter Healthcare Corporation, Deerfield, Illinois, by letter on August 4, 1997. DISTRIBUTION Nationwide. QUANTITY 5,229 instruments were distributed. REASON The use of 250 ml anticoagulant containers may result in the potential for donor air embolus when performing plasmapheresis with the Autopheresis-C instrument. -10- END OF ENFORCEMENT REPORT FOR OCTOBER 1, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for