July 12, 2000 00-28RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-835-0. CODE Unit Numbers: 30GX31918 and 30GM00559. MANUFACTURER American National Red Cross, Ashley, Pennsylvania. RECALLED BY Manufacturer, by letter on either October 11, 1999, or February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 2 units were distributed. REASON Blood products were collected from two donors who reported travel to areas designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-849-0. CODE Unit #19LS01680. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter dated March 4, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported having lived in an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-851-0. CODE Unit #19GK36159. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letters on November 14, 1999, and December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee. 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) Platelets; b) Platelets, Pheresis, Leukoreduced. Recall #B-854/855-0. CODE a) Unit #19GL25891; b) Unit #19GL24837. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter dated July 30, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and Kentucky. 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. Recall #B-859-0. CODE Unit Numbers: 04KK15466 and 04KK20417. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated February 25, 2000, and March 27, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. 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) Recovered Plasma. Recall #B-863/864-0. CODE Unit #19GS25952. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter on March 23, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and Switzerland. 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, Leukoreduced; b) Platelets; c) Recovered Plasma. Recall #B-865/867-0. CODE Unit #19GF2679. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter dated August 16, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee 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 B. ________ PRODUCT Platelets, Pheresis. Recall #B-872-0. CODE Unit Numbers: 30GP12388 and 30GP13479. MANUFACTURER American National Red Cross, Ashley, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 16, 1999, and by letters on April 20, 1999, and May 6, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 2 units were distributed. REASON Blood products had unacceptable platelet counts. _______ PRODUCT Platelets, Pheresis. Recall #B-873-0. CODE Split Unit #53P79227. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on April 18, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 split unit was distributed. REASON Blood products had high white blood cell counts. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Irradiated. Recall #B-874-0. CODE Unit Numbers: 19GL26734 and 19GL26820. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter dated September 1, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 2 units were distributed. REASON Blood products had unacceptable platelet counts. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-875-0. CODE Unit #19GL27002. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by telephone on August 17, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-876-0. CODE Unit #19GQ03108. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by telephone on May 20, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-834-0. CODE Unit #T52966. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on April 11, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had an elevated body temperature. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-843/844-0. CODE Unit #19GK35311. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letter dated July 9, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a corneal transplant within a year of donation. ________ PRODUCT Red Blood Cells for Manufacturing Use Only. Recall #B-850-0. CODE Unit #19GH24069. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by letters dated June 7 and 11, 1999. 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, Leukocytes Reduced. Recall #B-871-0. CODE Unit #04KF24722. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on February 2, 2000, and by letter dated February 8, 2000. Firm-initiated recall complete. DISTRIBUTION Vermont. QUANTITY 1 unit was distributed. REASON Red Blood cells failed red cell recovery ratio.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
________ PRODUCT Various Surgical Trays and Procedure Kits containing Sterile Skin Preparations recalled by Clinipad Corporation. Recall #Z-836-0. CODE Lot Numbers: 715786, 805817, 812873 (Class I). (Note: If necessary, a complete list of catalog and lot numbers can be obtained from the Kansas City District Office. MANUFACTURER Ni-Med, Division of Oak Medical Industries, L.L.C., Farmington, Missouri. RECALLED BY Manufacturer, by letter on March 21, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY Approximately 2,000,000 trays/kits were distributed were distributed. REASON Class I - Products may be contaminated with bacteria. Class II - Trays/kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits/trays identified as containing Clinipad Sterile Skin Preparations with Lot Numbers 715786, 805817 and 813873 - Class I. Kits/trays identified as not containing the above lot numbers, for which the sterility could not be assured - Class II. ________ PRODUCT Various Percutaneous Endoscopic Gastronomy Kits containing Clinipad Iodophor PVP Povidone Iodine Antiseptic Swabsticks recalled by Clinipad Corporation. Recall #Z-837-0. CODE Lot Numbers: 812873, 800468, 807006, 815959, 900359, 818749, 900559, 900560, 902649, 905001 and 911138. MANUFACTURER Boston Scientific Corporation, Natick, Massachusetts. RECALLED BY Manufacturer, by letter on March 30, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connectitcut. DISTRIBUTION Nationwide. QUANTITY 89,303 kits were distributed. REASON Class I - Products may be contaminated with bacteria. Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits manufactured with the recalled swabsticks, Lot No. 812873 - Class I. Kits containing swabsticks with Lot Nos. 800468, 807006, 815959, 900359, 818749, 900559, 900560, 902649, 905001 and 911138, for which the sterility could not be assured - Class II. ________ PRODUCT Various Kits containing Iodophor PVP Povidone 1% Solution Antiseptic, 1 fluid ounce recalled by Clinipad Corporation. Recall #Z-838-0. CODE All lot numbers. MANUFACTURER Cook, Inc., Bloomington, Indiana. RECALLED BY Manufacturer, by letter on March 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 60,000 kits were distributed. REASON Class I - Products may be contaminated with bacteria. Class II - Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits with the antiseptic solution, Reorder #394-SB, Lot No. 812422 - Class I. Kits with antiseptic solutions with Lot Nos. other than 812422, for which the sterility could not be assured - Class II. ________ PRODUCT Various Custom Procedural Kits containing antiseptic products recalled by Clinipad Corporation. Recall #Z-839-0. CODE (Note: If necessary, a complete of catalog and lot numbers can be obtained from the Los Angeles District Office. MANUFACTURER Professional Hospital Supply, Inc., Temecula, California. RECALLED BY Manufacturer, by letter on or about March 17, 2000, or by fax on or about March 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The antiseptic products may be contaminated with bacteria.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Kits/Trays containing recalled Clinipad products, 86 different Cook catalog order numbers. (Note: If necessary, a complete list of devices, catalog and lot numbers can be obtained from the Detroit District Office Recall Coordinator). Recall #Z-829-0. CODE All catalog order numbers containing one of the following five prefixes: J-CHSGY, J-MHSGY, J-SBHS, J-TCY, AND J-DANY. MANUFACTURER Cook Urological, Spencer, Indiana. RECALLED BY Manufacturer, by letter on March 17, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 13,812 kits. REASON Kits/trays contain Clinipad products labeled as sterile which Clinipad is unable to assure the sterility. ________ PRODUCT a) Bard Button Device Decompression Tubes; b) Bard Replacement Gastrostomy Device Kit. Recall #Z-855/856-0. CODE All lot numbers. MANUFACTURER C.R. Bard, Inc., Mentor, Ohio. RECALLED BY C.R. Bard, Inc., Billerica, Massachusetts, by letter on May 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 63,345 units were distributed. REASON The device may be partially occluded (due to mold flash) causing narrowing in the through-hole. _______ UPDATE Abbott Plum XL Series Infusion Pumps, single and triple line infusion pumps utilizing I.V. administration set cassettes, Recall #Z-821/826-0, which appeared in the July 5, 2000 Enforcement should read: Firm- initiated field correction.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
________ PRODUCT Medalist Natural Pig Ears, packaged in 25-count poly bag. Recall #V-101-0. CODE 07600EXU3 and 08300EXU1. MANUFACTURER Treat Makers, L.L.C., Hutchinson, Kansas. RECALLED BY Manufacturer, by telephone on May 12, 2000. A press release was issued by Farmland Industries (parent company for Treat Makers) on May 19, 2000. See also FDA press release P00-12, May 23, 2000 (revised May 26, 2000. Firm-initiated recall complete. DISTRIBUTION Washington, Oregon, California, Arizona, New Mexico, Nevada, Utah, Colorado, Idaho, Hawaii and Montana. QUANTITY 81,875 pig ears were distributed. REASON Product positive for Salmonella. END OF ENFORCEMENT REPORT FOR JULY 12, 2000. ####
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