The FDA Enforcement Report is published weekly by the Food and DrugAdministration,U.S. Public Health Service, Department of Health and Human Services. It containsinformationon actions taken in connection with agency regulatory activities.
ENFORCE 01/11/1995 Recalls and Field Corrections: Foods -- Class II -- 01/11/1995 January 11, 1995 95-2 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II==================== _______________ PRODUCT (a) Frio brand Fresh Frozen Leaf Spinach, in 3 pound cardboard cartons; (b) Sysco brand Imperial Chopped Spinach, in 3 pound cardboard cartons. Recall #F-159/160-5. CODE Lot numbers: (a) 44700211, 44700215; (b) 44700201. MANUFACTURER Dean Foods Vegetable Company, formerly Frio Foods, Inc.,Uvalde, Texas. RECALLED BY Manufacturer, by telephone August 17, 1994. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey, Florida. QUANTITY 404 cases (3 cartons per case) were distributed; firm estimates none remains on the market. REASON There is no tolerance established for Esfenvalerate in spinach -- residues of this pesticide were found in the product. _______________ PRODUCT Royal Dinnerware Harvest Festival: (a) 12 piece Dinner Set, Item #251944; (b) 4 piece Soup Plate Set, Item #251903; (c) 2 Piece Completer Set, Item #251943; (d) Fruit/Salad Bowl, 1 piece, Item #251913; (e) Oval Vegetable Bowl, 1 piece, Item #251935; (f) Turkey Platter, 1 piece, Item #251911. Recall #F-161/166-5. CODE All lots. MANUFACTURER Mogi Trading Company, Ltd., Nagoya, Japan. RECALLED BY Mid-America Tablewares, Inc., Eau Claire, Wisconsin, by letter October 14, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY It was estimated that 200 of the 12-piece dinner sets and 300 of the smaller sets were on the market at the time of recall initiation. REASON Product contains excessive levels of leachable lead. _______________ PRODUCT Bok Choy, in carton boxes of 35 pounds, 50 pounds, and 65 pounds. Recall #F-175-5. CODE Lot #760. MANUFACTURER Nat Feinn and Son, Inc., Fresno, California. RECALLED BY Manufacturer, by letter October 31, 1994. Firm-initiated recall complete. DISTRIBUTION California, Georgia, Minnesota, Ohio, Pennsylvania, Texas, Wisconsin, Canada. QUANTITY 37,380 pounds were distributed; FDA estimated that 2,000 to 3,000 pounds remained on market at time of recall initiation. REASON There is no established tolerance for Fenvalerate in Bok Choy -- residues of this pesticide were found in the product. _______________ PRODUCT Kitchen Fresh Pistachio Nut Salad, packaged in 6 pound plastic containers, 2 containers per case. Recall #F-176-5. CODE Sell by November 12-94 through December 08-94. MANUFACTURER Ozark Salad Company, Inc., Baxter Springs, Kansas. RECALLED BY Manufacturer, by letter dated November 2, 1994, and by telephone November 4, 1994. Firm-initiated recall complete. DISTRIBUTION Kentucky, Oklahoma, Louisiana, Kansas, Missouri, Idaho, Colorado, North Carolina, Arkansas, Arizona. QUANTITY 1,089 cases were distributed. REASON Product contains undeclared FD&C Yellow No. 5. _______________ PRODUCT Shurfresh brand Cole Slaw packaged in 5 pound plastic containers, 2 containers per case. Recall #F-178-5. CODE Sell by November 12-94 through December 05-94. MANUFACTURER Ozark Salad Company, Inc., Baxter Springs, Kansas. RECALLED BY Manufacturer, by letter dated November 2, 1994, and by telephone November 4, 1994. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 150 cases were distributed. REASON Product contains undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III============= _______________ PRODUCT Keebler Toasteds Compliments Sesame Crackers, Item #32417, in 8 ounce boxes. Recall #F-149-5. CODE Lot numbers: 122W, 123U, 131U, 131W, 138U, 145W, 151W, 151Z, 161W, 166U, 179U, 180U. MANUFACTURER Keebler Company, Macon, Georgia. RECALLED BY Keebler Company, Elmhurst, Illinois, by visit beginning August 3, 1994, and by telephone August 5, 1994. The Food Allergy Network was also notified. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 29,586 boxes were distributed; firm estimated that 30 percent of the product remained on market at time of recall initiation. REASON Product is mislabeled. The crackers are labeled with the "K Pareve" legend and they contain whey. _______________ PRODUCT Grape Juice from Concentrate, unsweetened, fortified with Vitamin C, net contents 46 fluid ounces per can. Recall #F-167-5. CODE WJI/94273. MANUFACTURER Krier Foods, Inc., Random Lake, Wisconsin. RECALLED BY Manufacturer, by telephone October 7, 1994. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 952 cases (12 cans per case) were distributed; firm estimates that none remains on the market. REASON Product was contained in leaking cans. _______________ PRODUCT Caffeine Free Diet Coke, in 12 fluid ounce cans, and in 20 fluid ounce non-returnable plastic bottles. Recall #F-172-5. CODE All bottles bearing use by date of 01/16/95. MANUFACTURER Big Springs, Inc., Huntsville, Alabama. RECALLED BY Manufacturer, by telephone on or about October 25, 1994. Firm-initiated recall complete. DISTRIBUTION Alabama, Tennessee. QUANTITY 1,099 cases (24 cans per case) and 256 cases (24 bottles per case) were distributed. REASON Product contains trace amounts of carbohydrates indicative of nutritive sweetener. _______________ PRODUCT Stop & Shop Stuffing Mix, Chicken Flavor, in 12 ounce paperboard canister with plastic lid. Recall #F-174-5. CODE All lots. MANUFACTURER Colona, North Bergin, New Jersey. RECALLED BY Stop & Shop Supermarket Company, Quincy, Massachusetts, by electronic mail message November 7, 1994. Firm-initiated recall complete. DISTRIBUTION Connecticut, New York, Massachusetts, Rhode Island. QUANTITY 3,356 cases were distributed. REASON Product is mislabeled. Sodium content was labeled as 55 mg per serving but actually contained 420 mg per serving. _______________ PRODUCT Buttermilk Cornmeal Mix, enriched, self-rising, packaged in 5 pound paper bags, 10 bags per bale. Recall #F-173-5. CODE The individual bags are coded with an expiration date derived by adding nine months to the packaging date. The recall involves three packaging dates 09/14/94, 09/15/94, 09/16/94 for which the bags were coded 14JUN951, 15JUN951, 16JUN951. MANUFACTURER The White Lilly Foods Company Knoxville, Tennessee. RECALLED BY Manufacturer, by telephone September 20, 1994. Firm- initiated recall complete. DISTRIBUTION Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia. QUANTITY 1,750 bales were distributed prior to recall initiation. REASON Product is contaminated with coal tar pitch. _______________ PRODUCT Fresh Made Sunflower Oil, packaged in 24 ounce plastic bottles. Recall #F-177-5. CODE None. MANUFACTURER Fresh Made, Inc., Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter March 24, 1994. Firm-initiated recall ongoing. DISTRIBUTION New York, Pennsylvania. QUANTITY Firm estimates that little if any product remains on the market. REASON Product is labeled as sunflower oil and is primarily soybean oil. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II====== _______________ PRODUCT Cleocin Phosphate 600 mg/50 ml IV Solution, an antibiotic. Recall #D-042-5.CODE Lot #418XR. MANUFACTURER Baxter Healthcare Corporation, Carolina, Puerto Rico. RECALLED BY The Upjohn Company, Kalamazoo, Michigan, by letter January 10, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 13,032 bags were distributed; firm estimates none remains on the market. REASON Some product carton covers incorrectly declare the strength as 900 mg/50 ml instead of 600 mg/50 ml. The carton base and I.V. bags are correctly labeled. _______________ PRODUCT Touro LA Caplet, in 100 caplet bottles, Rx drug indicated as a time released decongestant/expectorant. Recall #D-043-5. CODE Lot #70C1230 EXP 3/96. 4- MANUFACTURER Wildflower Pharmacal Corporation, Mineola, New York. RECALLED BY Dartmouth Pharmaceuticals, Marion, Massachusetts, by telephone beginning December 28, 1994, followed by letters of January 5 and 9, 1995. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Maine, Connecticut, Georgia, New York, New Jersey. QUANTITY 3,839 100-caplet bottles and 34,500 unit dose caplets were distributed. REASON Product does not meet time release specifications. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I=== _______________ PRODUCT PK "R" Syringe, Catalog #2M1361. Recall #B-125-5. CODE Lot #940406. MANUFACTURER Olympus Optical Company, Ltd., Tokyo, Japan. RECALLED BY Olympus American, Inc., Lake Success, New York, by letters dated September 28, 1994, followed by telephone September 30, 1994. Firm-initiated recall ongoing.DISTRIBUTION Oklahoma, Missouri, North Carolina, Pennsylvania, Michigan, Massachusetts, Wisconsin, Texas, Arizona, New Jersey, Washington State, Rhode Island, California, New York, Canada. QUANTITY 24 units. REASON Olympus brand 2 PK7100 instrument syringes, packed in boxes that were mislabeled as containing larger syringes, were distributed. _______________ PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells, for Further Manufacture; (d) Platelets; (e) Platelets, Expired; (f) Fresh Frozen Plasma; (g) Recovered Plasma. Recall #B-126/132-5. CODE Contact FDA, Center for Biologics Evaluation and Research, Recall and Administrative Actions Branch (301)-827-6220* for individual unit numbers recalled. MANUFACTURER Blood Systems, Inc., doing business as United Blood Services, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated April 28, 1994, and June 13, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY (a) 9 units; (b) 1,888 units; (c) 6 units; (d) 1,253 units; (e) 4 units; (f) 862 units; (g) 32 units. REASON Blood products, collected in a manner that compromises the sterility of the collection system, were distributed. _______________ PRODUCT Red Blood Cells. Recall #B-135-5. CODE 16FS02345. MANUFACTURER American National Red Cross (The), Columbus, Ohio. RECALLED BY Manufacturer, by letter July 8, 1994. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit. REASON Blood product, which was collected from a donor who admitted to visiting an area designated as endemic for malaria, was distributed. --------------- PRODUCT Red Blood Cells. Recall #B-137-5. CODE Unit numbers 12E67750, 12Q86242. MANUFACTURER The American National Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone June 7, 1994, followed by letter June 8, 1994. Firm-initiated recall complete. DISTRIBUTION North Carolina, Tennessee. QUANTITY 2 unit. REASON Blood products, collected from an ineligible donor due to a reported history of cancer, were distributed. _______________ PRODUCT (a) Red Blood Cells, Frozen; (b) Platelets, Pheresis. Recall #B-141/142-5. CODE Unit numbers: (a) 60W99783; (b) 60P26511. MANUFACTURER The American National Red Cross, Miami, Florida, by telephone October 8, 1993, followed by letter October 20, 1993. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component. REASON Blood products, incorrectly tested for syphilis, were distributed. _______________ PRODUCT Red Blood Cells. Recall #B-147-5. CODE Unit #8114307. MANUFACTURER Midland County Hospital District, doing business as Permian Basin Regional Blood Center. Midland, Texas. RECALLED BY Manufacturer, by telephone July 29, 1993. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit. REASON Blood product, collected from a therapeutic donor and not labeled to indicate the type of donor and disease state, was distributed. _______________ PRODUCT Source Plasma. Recall #B-149-5. CODE Unit #XG81519. MANUFACTURER Immuno-U.S., Inc., Columbus, Georgia. RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by letter June 14, 1994. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 1 unit. REASON Blood product, which tested non-reactive for hepatitis B surface antigen (HBsAg), but was collected from a donor who previously tested repeatedly reactive for HBsAg, was distributed. _______________ PRODUCT Source Plasma. Recall #B-150-5. CODE Unit numbers: PG10220, PG10280, PG10560, PG10614, PG10885, PG10985, PG11205, PG11269, PG11456, PG11619, PG11713, PG11892, PG12004, PG12187, PG12298, PG12555, PG12651, PG12808, PG13078, PG13161, PG13444, PG13649, PG13752, PG14037, PG14149, PG14889, PG15134, PG15426, PG15860, PG16265, PG16535, PG16903, PG17481, PG17582, PG17961, PG18022, PG18499, PG18601, PG19074, PG19252, PG19674, PG19785, PG20170, PG20333, PG20802, PG20958, PG21366, PG21567, PG22148, PG22716, PG22786, PG23187, PG23388, PG23938, PG24356, XG64861, XG67393, XG67536, XG68201, XG68395, XG68982, XG69174, XG69862, XG69979, XG70682, XG70795, XG71555, XG71645, XG72320, XG72491, XG73060, XG73222, XG73892, XG74052, XG74741, XG74890, XG75431, XG75657, XG76123, XG76298, XG76887, XG77071, XG77718, XG77820, XG78248, XG78549, XG79008, XG79165, XG79778, XG80066, XG80597, XG80749, XG81360, XG81572, XG82153, XG82346, XG82863, XG83096, XG83642, XG83728, XG84289, XG84468, XG85054, XG85197, XG85732, XG85854, XG91119, XG91303, XG91755, XG92152, XG92386, XG92720, XG93175, XG93665, XG94177, XG94349. MANUFACTURER Community Bio Resources, Inc., Columbus, Georgia. RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by letter dated June 14, 1994. Firm-initiated recall complete. DISTRIBUTION Michigan, New Jersey, Austria. QUANTITY 116 units. REASON Blood products, which tested non-reactive for hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested repeatedly reactive for HBsAg, were distributed. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III====== _______________ PRODUCT Recovered Plasma. Recall #B-136-5. CODE Unit #20KK00749. MANUFACTURER The American National Red Cross, Boise, Idaho. RECALLED BY Manufacturer, by letter December 1, 1993. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit. REASON Blood product, corresponding to a unit of Red Blood Cells found to be contaminated with Serratia liquefaciens was distributed. _______________ PRODUCT Recovered Plasma. Recall #B-138-5. CODE Unit numbers 12E67750, 12Q86242. MANUFACTURER The American National Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter June 24, 1994. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units. REASON Blood product, collected from an ineligible donor due to a reported history of cancer, was distributed. _______________ PRODUCT (a) Platelets, Pheresis; (b) Leukocytes. Recall #B-139/140-5. CODE Unit numbers: 12FL95637, 12FL95638, 12FL95640, 12FL95641, 12FM73988, 12FM73989, 12FM73990, 12FM73991, 12FM73992, 12FM73993, 12FM73994, 12FM73995, 12FM73998, 12LT17880, 12LT17881, 12LT17882, 12LT17883, 12LT17884, 12LT17885, 12T77772, 12T77774, 12T77775, 12T77778, 12T77782, 12T77784, 12T77786, 12T77787, 12T77789, 12T77791, 12T77796, 12T77797, 12T77801, 12T77809; (b) 12Y53328, 12Y53337, 12Y53339, 12Y53340, 12Y53343, 12Y53345. MANUFACTURER The American National Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone July 19, 1994, followed by letters dated July 21, 1994, and August 2, 1994. Firm- initiated recall complete. DISTRIBUTION (a) Georgia, North Carolina; (b) North Carolina. QUANTITY (a) 33 units; (b) 6 units. REASON Blood products, that were either incorrectly tested for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2; or incorrectly tested for anti-HIV-1/2 and antibody to hepatitis B core antigen (anti-HBc), were distributed. _______________ PRODUCT Platelets. Recall #B-143-5. CODE Unit numbers: 1177958, 1177959, 1177960, 1177961, 1177962, 2651767, 2651769, 2651770, 2651771, 2651772, 2651774, 2651775, 2651776, 2651780, 2651782, 2651783, 2651784. MANUFACTURER Houchin Community Blood Bank, Bakersfield, California. RECALLED BY Manufacturer, by letter September 22, 1994. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 17 units. REASON Blood products, which were exposed to unacceptable storage temperatures, were distributed. _______________ PRODUCT Plasma. Recall #B-144-5. CODE Unit #11047-7109. MANUFACTURER United Blood Services Blood Systems, Inc., El Paso, Texas. RECALLED BY Manufacturer, by letter July 7, 1994. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit. REASON Plasma, prepared later than eight hours after phlebotomy and mislabeled as Fresh Frozen Plasma, was distributed. _______________ PRODUCT Red Blood Cells. Recall #B-145-5. CODE Unit #8118331. MANUFACTURER Midland County Hospital District, doing business as Permian Basin Regional Blood Center, Midland, Texas. RECALLED BY Manufacturer, by telephone October 14, 1993. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit. REASOn Autologous blood product, that tested repeatedly reactive for hepatitis B surface antigen (HBsAg) but was not appropriately labeled to reflect the HBsAg reactive result, was distributed. _______________ PRODUCT Corzyme Hepatitis B Core Antigen (Recombinant Diagnostic Kit. Recall #B-146-5. CODE Lot numbers: 92717M300, 92718M300. MANUFACTURER Abbott Laboratories, Abbott Park, Illinois. RECALLED BY Manufacturer, by letter October 19, 1994, followed by telephone on October 20 and 21, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 538 test kits were distributed; firm estimates none remains on the market. REASON Antibody to hepatitis B core antigen (anti-HBc) test kits, that may demonstrate increased reactive rates, were distributed. _______________ PRODUCT Red Blood Cells. . Recall #B-148-5. CODE Unit numbers: 5516660, 5516663, 5516665, 5516667. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter January 27, 1994. Firm-initiated recall complete. DISTRIBUTION Washington State. QUANTITY 4 units. REASON Blood products labeled with incorrect expiration dates were distributed. _______________ PRODUCT HIVAB Antibodies to Human Immunodeficiency Virus Types 1 and 2 Test Kits. Recall #B-151-5. CODE Lot numbers: 92015M201, 92016M201, 92115M101, 92115M102, 92363M301, 92413M101, 92558M202, 92560M201, 92560M202, 92561M201, 92626M101, 92626M102, 92986M201, 92986M202, 92987M201, 93253M101, 93258M101, 93259M101, 93260M10. MANUFACTURER Abbott Laboratories, Abbott Park, Illinois. RECALLED BY Manufacturer, by letters of November 30, 1994, and December 8, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 6,100 kits were distributed; firm estimated that 1,500 kits remained on market at time of recall initiation. REASON Antibody to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2) test kits, that may demonstrate increased reactive rates, were distributed. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II======== _______________ PRODUCT Ophthalmic surgical devices: (a) Storz Premiere 24hr. Pack, Irrigation/Aspiration Tube Set, Sterile/Single Patient Use, Catalog #DP5000 (packaged 10 units per case); (b) Storz Premiere 24hr. Pack, Collection Cassette, Sterile/Single Patient Use, For Anterior Segment Surgery Use Only, Catalog #DP5100 (packaged 6 units per case); (c) Storz Premiere 24hr. Pack, Irrigation Administration Set, Sterile/Single Patient Use, Catalog #DP5200 (packaged 10 units per case). Recall #Z-205/207-5. CODE Lot numbers: (a) 1511DAD, 1511DA, 3212D, 2853E, 3373E, 0324E, 1511DAE, 1981D, 3302D, 3013E, 3473E, 0394E, 1511DAF, 2281D, 3422D, 3133E,0064E, 0734D, 1511DAB, 2582D, 3532D, 3153E, 0114E, 0814D, 1511DAC, 3102D, 0053D, 3233E, 0204E, 2972D; (b) 2061D, 3241D, 2612D, 0973E, 0214D, 1711D, 0062D, 3212E, 1803E, 0494E, 2351D, 0282D, 3522E, 2033D, 0624D, 2761D, 1632D, 0253D, 2233D, 0974D, 3041D, 2062D, 0293D, 3153E; (c) 2052D, 3041D, 3242E, 1323E, 3283E, 0874D, 2061D, 3241D, 3522D, 1793E, 0144D, 2351D, 0272D, 0283D, 2023D, 0184D, 1721D, 1322D, 0843D, 2223D, 0534E, 2761D, 26121D, 0963E, 2433D, 0624E. MANUFACTURER Storz Instrument Company, St. Louis, Missouri. RECALLED BY Manufacturer, by letter May 6, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY (a) 8,085 units were distributed between 7/31/91 and 3/30/94; (b) 637 units were distributed between 7/31/91 and 3/24/94; (c) 1,289 units were distributed between 7/31/94 and 4/8/94. REASON Pinhole leaks were found in the Tyvek plastic side of the pouches used to package the products, which could cause the sterility to be compromised. _______________ PRODUCT Upsizing Sleeves, Models 033-240, 030-221, and 033-210 when used in the ventricular channel of the Reflex 8223E pulse generator. Recall #Z-230/232-5. CODE All codes. MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida. RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by mailing notices on September 30, 1994 and October 3, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,691 units were distributed. REASON The leads used with the above models of Upsizing sleeves may not allow for a proper connection in the ventricular channel of the reflex 8223E pulse generator. _______________ PRODUCT Pacesetter "AFP" Multi-mode/programmable cardiac pulse generators (pacemaker or pacer): (a) Model 275; (b) Model 281; (c) Model 283. Recall #Z-238/240-5. CODE Serial numbers: (a) 12257, 12266, 12414, 12422, 12456; (b) 102 units within the serial number sequence 10630 through 13861; (c) 34 units within the serial number sequence 12100 through 12480. MANUFACTURER Pacesetter, Inc., Sylmar, California; Reeves-Hoffman, Carlisle, Pennsylvania (crystal). RECALLED BY Pacesetter, Inc., Sylmar, California, by letter October 17, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 181 units. REASON A defective crystal in the "AFP" pacer, causes the device to suddenly stop operating. _______________ PRODUCT Wizard Personal Organizer and Pacemaker Database, Software Revision 1. Recall #Z-241-5. CODE All serial numbers. MANUFACTURER Telectronics Pacing Systems, Englewood, Colorado. RECALLED BY Manufacturer, by telephone, followed by letter August 1, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 218 total Version 1 cards were distributed. REASON The firm failed to file a 510(k) Pre-Market Notification for their Wizard Personal Organizer, Software Revision 1 Database. _______________ PRODUCT Cordis Webster Braided-Tip Deflectable Electrophysiology Catheters, indicated for electrophysiological mapping of cardiac structures: (a) Model D78; (b) Model D88; (c) Model D7-270; (d) Model 1104; (e) Model 1105; (f) Model 1108. Recall #Z-246/251-5. CODE All lots. Expiration dates: 7/95 - 10/97. MANUFACTURER Cordis Webster, Inc., Baldwin Park, California. RECALLED BY Manufacturer, by letters dated October 26, 1994. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 5,390 units were distributed. REASON The tip electrode can come loose due to lack of bond adhesion caused by the Dacron braid material interacting with the polyurethane adhesive. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III============ _______________ PRODUCT First Choice Blood Glucose Test Strips for the Glucometer 3 Meter: (a) Catalog #91060, Bottle of 50 Strips; (b) Catalog #91061, Two Bottles of 50 Strips; (c) Catalog #91065, Blister Pack of 50 Strips. Recall #Z-202/204-5. CODE Lot numbers: (a) E18031, E18034, E18036, E18038, E18040, E18041, E18053, E18054, F18060, F18061, F18062, F18073, F18093, F18094, F18134; (b) E18031, E18036, E18038, E18040, F18093, F18094, F18134; (c) E18034, E18038, E18040, E18054, F18060, F18093, F18134. MANUFACTURER Polymer Technology International (PTI) Issaquah, Washington. RECALLED BY Manufacturer, by letter September 6, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide, Argentina, Lebanon, Pakistan. QUANTITY 61,119 bottles were distributed. REASON The blood glucose strips could provide low patient results. _______________ PRODUCT Difco Bacto Blood Collectors, Product #1832-30, intended for collecting blood samples used in clinical diagnosis. Recall #Z-218-5. CODE Lot numbers: 20530JA, 20530JB. MANUFACTURER Deltar - Diamed Operation, Elk Grove Village, Illinois. RECALLED BY Difco Laboratories, Detroit, Michigan, by letter October 11, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 67,000 units were distributed. REASON The 21 gauge winged venipuncture needle may be covered with a hard brown rust-like coating. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III====== _______________ PRODUCT Diethyl Ether, in 150 ml cans, used primarily as an anesthetic by veterinarians on animals. Recall #V-004-5. CODE Lot #0804-17 on cans; 0804-18 on cases. MANUFACTURER Mallinckrodt Chemical, Paris, Kentucky. RECALLED BY Manufacturer, by letter November 8, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 3,370 cans were distributed. REASON Ether does not meet USP specifications. _______________ PRODUCT "Snap" Beta-Lactam Test Kit, an enzyme-linked receptor- binding assay which will detect penicillin, cephapirin, amoxicillin and ceftiofur residues in raw combined bovine milk at or below established tolerance and/or safe levels. Recall #V-005-5. CODE Kit product #01679. All product codes from April 1993 to May 1994. The last two alphabetical letters (A=January, B=February, etc. and K=1993 and 1=1994) preceded by 01679 are the only digits necessary for identifying the product. MANUFACTURER Idexx Laboratories, Inc., Westbrook, Maine. RECALLED BY Manufacturer, by telephone October 21, 1994. Firm-initiated recall complete.DISTRIBUTION Nationwide. QUANTITY 45,000 kits were distributed. REASON Test kit was not always sensitive to amoxicillin. _______________ PRODUCT Layer Feed 17% AU CR. Recall #V-006-5. CODE Date of Production - November 9, 1994. MANUFACTURER Molinos De Puerto Rico, Guaynabo, Puerto Rico. RECALLED BY Manufacturer, by telephone November 10, 1994. Firm- initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 57,300 pounds were distributed. REASON Inadequate flushing procedures. A lot of Pig Grower LN40 containing Lincomycin was mixed and the operator failed to flush the mixing equipment before mixing a lot of layer feed. _______________ PRODUCT Xenodine Polyhdydroxydine Solution, OTC topical microbicide, in 1 fluid ounce and 1 gallon containers. Recall #V-007-5. CODE AKL120 EXP 10/96, BAL244 EXP 1/97, BBL300 EXP 2/97, BFL474 EXP 6/97, BJL583 EXP 9/97 (1 fluid ounce bottles); BFL 491 EXP 6/97 (1 gallon jug). MANUFACTURER Solvay Animal Health, Inc., Charles City, Iowa. RECALLED BY Manufacturer, by letters of August 8, 1994, and November 17, 1994. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 130,260 1-ounce bottles and 171 1-gallon jugs were distributed. REASON Failure of product to maintain potency through expiration date. END OF ENFORCEMENT REPORT FOR JANUARY 11, 1995. ####