FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

September 29, 1999                                       99-39

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT Bumble Bee brand Chunk Light Tuna in Water, in 6 ounce cans. Recall #F-669-9. CODE CLP4T over F16CC. MANUFACTURER Bumble Bee Seafoods, Inc., Santa Fe Springs, California. RECALLED BY International Home Foods, Inc., Parsippany, New Jersey, by E-mail, fax, and press release on August 30, 1999. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Mississippi, Colorado, Washington state. QUANTITY 1,196 cases (48 cans per case) were distributed. REASONS Product contained high levels of histamine and was associated with histamine poisoning.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________ PRODUCT TUSSIONEX Pennkinetic (hydrocodone polistirex), extended- release suspension (Hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and Chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate), in 473 mL bottle, Rx medication for relief of cough and upper respiratory symptoms associated with allergy or a cold. NDC #53014-548-67. Recall #D-423-9. CODE 90299, EXP 04/01 90300, EXP 04/01 90301, EXP 04/01 90302, EXP 04/01 90303, EXP 04/01 90309, EXP 05/01 90310, EXP 05/01. MANUFACTURER Medeva Pharmaceuticals, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter dated August 6, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Lot 90299: 7,491 units were distributed between 5/17/99 and 5/19/99. Lot 90300: 7,622 units were distributed between 5/18/99 and 5/28/99. Lot 90301: 7,702 units were distributed between 5/28/99 and 6/10/99. Lot 90302: 7,714 units were distributed between 5/24/99 and 6/15/99. Lot 90303: 3,166 units were distributed on 6/15/99 Lot 90309: 7,446 units were distributed between 5/25/99 and 6/10/99. Lot 90310: 7,637 units were distributed between 6/10/99 and 6/30/99. REASON Microbial contamination (acetobacter SPP).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-1190/1191-9. CODE Unit #16LE49081. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on June 10, 1999, and by letter dated June 11, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component. REASON Blood products were prepared from a unit of whole blood with an extended collection time.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ PRODUCT V.A.D. Access Kit/Dressing Change Tray, a sterile single use tray containing the equipment needed, including heparin lock flush, to change the dressing on a vascular access device. Recall #Z-1253-9. CODE Catalog #DC-680, Lot 906014, EXP 06/01. MANUFACTURER MEDIKMARK, Inc., Buffalo Grove, Illinois. RECALLED BY Manufacturer, by telephone on August 4, 1999, followed by letter on August 9, 1999. Firm-initiated recall ongoing. DISTRIBUTION Illinois, New York, Texas, Arizona. QUANTITY 360 trays. REASON Tray may contain 1000 u/ml heparin instead of 100 u/ml heparin. ________ PRODUCT Gammamed 12i and 12it High Dose Rate Afterloader Sources, used for HDR afterloader radiation therapy, radionuclide brachytherapy source. Recall #Z-1255/1256-9. CODE 6455-6464 (source). MANUFACTURER MDS Nordion/Theratronics International, Ltd., Kanata, Ontario, Canada. RECALLED BY Manufacturer, by letter August 12, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 36 units were distributed. REASON Use of substandard Ir-192 sealed sources may lead to overexposure of the patient to radiation with the potential for a significant overdose.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________ PRODUCT Omni-Jug Disposable Suction Canister, 15000 cc, for collection, transport, and disposal of large amounts of irrigation fluid generated during surgical procedures: a) Omni-Jug Disposable Suction Canister, Model #5036-00; b) Omni-Jug Disposable Suction Canister, Model #5036-01. Recall #Z-1243/1244-9. CODE O-rings are not coded; Canister lids are stamped with run dates of 7/5/99 to 7/26/99. MANUFACTURER Maryland Plastics, Inc., Federalsburg, Maryland. RECALLED BY Waterstone Medical, Inc., Falls Church, Virginia, by letter on July 29, 1999, followed by visit. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 8,000 units. REASON The O-ring component of the suction canister may fail to properly seal, which may not allow proper vacuum seal. ________ PRODUCT Latex and Non-Latex Operating Room and Area Shoe Covers; Non Latex Gripper Shoe Covers and Boot Covers, packaged in cases of 50, 100, 150, 200 and 300 covers each, under the American Health & Safety Sure-Tread label: a) NON23758 - Gripper Shoe Covers, Non-Conductive, Universal Size NON24758 - Gripper Shoe Covers, Non-Conductive, Universal Size NON24759 - Gripper Shoe Covers, Non-Conductive, X-Large b) NON24752 - Gripper Sport Shoe Covers, Sport Shoe Size NON24852 - Gripper Sport Shoe Covers, SMS Material, Sport Shoe Size c) NON24758R - Gripper Reverse Shoe Covers, Universal Size, Reverse Seam, Blue NON24759R - Gripper Reverse Shoe Covers, X-Large, Reverse Seam, Blue d) NON24758L - Gripper II Spunbond Shoe Covers, White e) NON27144 - Boot Cover Impervious Knee High No Latex NON27144XL - Boot Cover Impervious Knee High No Latex f) NON27752 - Shoe Cover w/Non Latex Grid Sport Size, NON27758R - Shoe Cover W/Non Latex Grid Reverse Blue, NON27759R - Shoe Cover W/Non Latex Grid X-Large Reverse, NON27852 - Shoe Cover W/Non Latex Grid Sport Size SMS g) NON27758 - Shoe Cover Gripper Non-Skid Blue No Latex, NON27759 - Shoe Cover Gripper Blue X-Large No Latex, h) AHS1151009 - American Heath & Safety Sure Tread Disposable Shoe Covers, Stretch Size 5-12. Recall #Z-1245/1252-9. CODE All lots ending with JC followed by a numeral of the part numbers/reorder numbers listed above. MANUFACTURER Hangzhou Jinchen Knitting & Textiles Co., Ltd., Hangzhou, China. RECALLED BY Medline Industries, Inc., Mundelein, Illinois, by letter dated August 27, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 39,266 cases. REASON Some of the shoe covers have the gripper pattern made of a water- soluble substance, and may smear or may be more prone to slippage if exposed to water. _______ PRODUCT Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay, a quantitative immunoassay for the determination of cardiac troponin-I levels in serum and Plasma: a) Catalog No. B5700-64 (Domestic), Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay - 120 Tests,; b) Catalog No. B5700-64R (International), Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay - 120 Tests. Recall #Z-1257/1258-9. CODE Lot Numbers: a) KXTN-1146 through KXTN-1204, KXTN-1206 through KXTN-1210, KXTN 1212, KXTN-1214, KXTN-1215 and KXTN-1219, EXP Dates from Oct. 28, 1999 through Feb. 18, 2000; b) KXTN-1146 through KXTN-1204, KXTN-1206 through KXTN-1210, KXTN 1212, KXTN-1214, KXTN-1215 and KXTN-1219, EXP Dates from Oct. 28, 1999 through Feb. 18, 2000. MANUFACTURER Dade Behring, Inc., Miami, Florida. RECALLED BY Manufacturer, by letter on April 14, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 12,604 kits were distributed. REASON The device may produce false positive test results. END OF ENFORCEMENT REPORT FOR SEPTEMBER 29, 1999. BLANK PAGES MAY FOLLOW.
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