February 23, 2000 00-08RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Jewel Bake Shop 12-Count Mini Danish Rolls, packaged in 15-ounce retail packages. Recall #F-107-0. CODE Sell Thru dates of 12/2/99 through 12/13/99. MANUFACTURER Meurer Bakeries of Milwaukee, Muskego, Wisconsin. RECALLED BY Jewel Food Stores, Melrose Park, Illinois, by E-mail, followed by press release on December 10, 1999, and visit. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Iowa, Indiana, Wisconsin. QUANTITY Undetermined. REASON Product contains undeclared peanuts, filberts, cashews, walnuts, pecans, almonds, coconut, and chocolate chips.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Wagner's Assorted Milk Chocolates, in 1-pound box. Recall #F-100-0. CODE None. All product in distribution. MANUFACTURER Wagner Candy Company, Finleyville, Pennsylvania. RECALLED BY Manufacturer, by visit beginning January 13, 2000. Firm- initiated field correction (relabeling) ongoing. DISTRIBUTION Pennsylvania. QUANTITY Firm estimated that 50 units remained on market at time of recall initiation. REASON Product contains undeclared FD&C Yellow No. 5 and sulfites. ________ PRODUCT a) Pasteurized Frozen Whole Eggs, in 30-pound pails; b) Pasteurized Liquid Whole Eggs, in 2,000-pound totes. Recall #F-105/106-0. CODE a) 210-9; b) 193-9 and 211-9. MANUFACTURER db Foods, Inc., Springdale, Arkansas. RECALLED BY Manufacturer, by telephone on August 9, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas and Florida. QUANTITY 17,276 pounds were distributed. REASON Products were contaminated with Salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT El Charrito brand "Naranja Agria/Bitter Orange" sauce packaged in 24-ounce glass bottles and 128-ounce plastic jugs with paper labels, used as barbecue sauce/seasoning for poultry, fish and meat. Recall #F-108-0. CODE All codes bearing incorrect nutrition facts panel. MANUFACTURER Lisy Corporation, Miami, Florida. RECALLED BY Manufacturer, by applying corrective labels beginning January 18, 2000. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Texas, North Carolina, Georgia, Florida. QUANTITY 48,000 mislabeled bottles were distributed. REASON Product bears an incorrect nutrition facts panel. ________ PRODUCT Fresca, soda pop in 12-ounce can. Recall #F-109-0. CODE Optimum taste date codes: JAN3100DD, FEB2100DD, MAR0600DD. MANUFACTURER Coca Cola Bottling Company of Los Angeles, Downey, California. RECALLED BY Manufacturer, by telephone on November 11, 1999, followed by visit and letter dated November 11, 1999. Firm-initiated recall complete. DISTRIBUTION California and Nevada. QUANTITY 18,887 cases (24 cans per case) were distributed. REASON Product contains undeclared acesulfame potassium (a sweetening agent). ________ PRODUCT Fresca, soda pop in 12-ounce cans. Recall #F-110-0. CODE FEB.2800 CCC and APR.0300 CCB. MANUFACTURER Coca-Cola Bottling Company United, Inc., Chattanooga, Tennessee. RECALLED BY Manufacturer, by letter on January 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Georgia, South Carolina, Tennessee. QUANTITY 5,400 cases (24 cans per case) were distributed. REASON Product contains undeclared acesulfame potassium (a sweetening agent).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Zen Liquid (1,4-Butanediol), in 35-fluid ounce bottles, OTC intended to be used as a sleep aid. Recall #D-219-0. CODE All Lot Numbers. MANUFACTURER Science Enhancement Systems, Inc., Delray Beach, Florida. RECALLED BY Manufacturer, by letter on January 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 5,400 bottles were distributed. REASON Product is an unapproved new drug.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Extra Strength Panadol PM Caplets, (500 mg Acetaminophen, 25 mg Diphenhydramine HCL), OTC, in bottles of 36 and 50 caplets and dispenser cartons of two caplets per pack. Recall #D-215-0. CODE Lot Numbers: PA033SH1 PA033SH2 PA027SJ2 PA083SH1 PA034SH1 PA035SH1 PA098SH1 PA036SH1 PA032SH1 PA027SJ4 PA028SJ1. EXP date for all lots: 07/2001. MANUFACTURER SmithKline Beecham, Dungarvan Ltd., Count Waterford, Ireland. RECALLED BY SmithKline Beecham, Consumer Health, Parsippany, New Jersey, by hand delivered letter beginning on January 27, 2000. Firm- initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 171,850 caplets were distributed. REASON Glass particles were found in bulk diphenhydramine used in manufacturing. ________ PRODUCT a) Solu-Medrol Methylprednisolone sodium succinate for injection, USP, 500 mg, single dose vial, 4 mL, sterile powder, b) Solu- Cortef Hydrocortisone sodium succinate for injection, USP, 100 mg, 2mL, Single dose vial, sterile powder, c) Solu-Cortef Hydrocortisone sodium succinate for injection, USP, 500 mg, 4 mL, Single dose vial, sterile powder, Recall #D-216/218-0. CODE a) NDC 0009-0765-02. Lots 02DAF and 23DAM EXP 3/31/01. b) NDC 0009-0900-20. Lot 29DAM EXP 3/31/04 NDC 0009-0900-13. Lot 48DCU EXP 6/30/04 NDC 0009-0912-05. Lots 51DCU and 52DCU EXP 6/30/04 c) NDC 0009-0912-05. Lots 51DCU and 52DCU EXP 6/30/04. MANUFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan. RECALLED BY Manufacturer, by letter dated January 27, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide, Bahamas, Cayman Islands, Colombia, Japan. QUANTITY 261,258 vials were distributed. REASON Lack of assurance of sterility.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Plasma, Cryoreduced. Recall #B-380/382-0. CODE Unit #21KL07421. MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on October 18, 1999, and by letter dated October 22, 1999. Firm-initiated recall complete. DISTRIBUTION Oregon and Kansas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Hepatitis A. ________ PRODUCT Red Blood Cells. Recall #B-384-0. CODE Unit #E02226. MANUFACTURER HCSC Blood Center, doing business as Miller Memorial Blood Center, Bethelhem, Pennsylvania. RECALLED BY Manufacturer, by letter dated June 9, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose body temperature had not been documented. ________ PRODUCT a) Red Blood Cells; b) Plasma, Liquid; c) Recovered Plasma. Recall #B-391/393-0. CODE Unit Numbers: a) 04C96628, 04GW03440, 04C01172, 04FN11593; b) 04C01172, 04FN11593; c) 04C96628, 04GW03440. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letters dated September 16, 1999, and November 3, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts and California. QUANTITY a) 4 units; b) 2 units; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of Hepatitis.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT ADCON-L, ANTI-ADHESION CONTROL IN A BARRIER GEL, packaged in a 5-gram aluminum tube, placed in a tyvek pouch, used by surgeons only during single-level, posterior, lumbar laminectomy, or laminotomy procedures, where roots are exposed to inhibit post- surgical peridural fibrosis. Recall #Z-335-0. CODE Catalog #G0001, Lot Numbers: A8069N1, A8106N1, A8138N1, A8145N1, A8153N1, A8180N1, A8187N1, A8201N1, A8208N1, A8216N1, A8236N1, and A8243N1. MANUFACTURER Gliatech, Inc., Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated April 29, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 13,800 units. REASON The sterility of the device cannot be assured due to a packaging defect. ________ PRODUCT ABIOMED(R) BVS 5000 and BVS 5000i BI-Ventricular Support System, a mechanical circulatory system for use in patients suffering reversible ventricular function. Recall #Z-351/352-0. CODE Serial Numbers: 1359-1396 and 1552-1738. MANUFACTURER Abiomed, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by fax on January 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 223 units. REASON Consoles will not switch into weaning mode when activated. ________ PRODUCT Tap, 7mm Bioscrew, Catalog #C8657. Recall #Z-353-0. CODE A60528, A60529, SA60819, SA60820, SA73981, SA86826, SB74552, SB74553, SB74554, SB74555, SB74556, SB74802, SB74803, SB99534, SC76127, SC76128, SD64343, SE84417, SE84418, SF66001, SH68532, SH68533, SJ69944, SJ69946, SJ69947, SJ73064, SK61267, SK61268, SK61269, SM62496,SM62497, SM62498, SM62504, EM62505,SM75666, SRB60070, SRB81696, SRB81697, SRB81698, SRB81699, SRB81700, SRF71142, SRF83000, SRK71511, SRL60388, SRM60390, SRM71588. MANUFACTURER Linvatec Corporation, Largo, Florida. RECALLED BY Manufacturer, by letter on December 20, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 537 units. REASON Screw may break at weld. ________ PRODUCT Joslyn Steam Sterilizer/Steam Modernization Kit, Model 1626 and 2038. Recall #Z-354/355-0. CODE Various serial numbers. MANUFACTURER Joslyn Sterilizer Corporation, Farmington, New York. RECALLED BY Steris Corporation, Mentor, Ohio, by letter dated January 31, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Colorado, Connecticut, Idaho, Illinois, Massachusetts, Michigan, New York, Ohio, Pennsylvania, Utah, Washington state. QUANTITY 60 units, REASON Retention bolts may fail due to fatigue. ________ PRODUCT Silon(tm) Transparent Wound Dressing. Recall #Z-356-0. CODE Lot Numbers: K1023, T2926-S264, T2930-S264, and T2931-S264. MANUFACTURER Bio Med Sciences, Inc., Bethelhem, Pennsylvania. RECALLED BY Manufacturer, by telephone starting December 15, 1999 through December 21, 1999, followed by letter on December 22, 1999. Firm-initiated recall ongoing. DISTRIBUTION Alaska, Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington state, France. QUANTITY 378 units. REASON Product's sterility may be compromised due to some of the pouches being inappropriately sealed. ________ PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01 and 2.11. MANUFACTURER Bayer Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by customer bulletin on December 22, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 660 units. REASON Software may incorrectly link previous assay results to a different patient ID. ________ PRODUCT Allograft Heart valve. Recall #Z-362-0. CODE Serial Numbers 387011, 3870081, 3873323, 3873331, 3893472, 3893499, 3874907, 3874893, 6028314, 6028322, 6189717. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on January 25, 2000. Firm-initiated recall complete. DISTRIBUTION Florida, Michigan, Ohio, Pennsylvania, South Carolina, Tennessee. QUANTITY 11 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Medical Tilt and Recline Chairs, allows patients to sit comfortably, includes tilt and recline features and has various accessories available including trays and headrests: Model Numbers: HTR3000, HTR3500, HTR5000, and HTR5500. Recall #Z-364/367-0. CODE All Serial Numbers beginning with 96H through 99E, inclusive. MANUFACTURER Invacare Corporation - Canada, Mississauga, Ontario, Canada. RECALLED BY Invacare Corporation, Elyria, Ohio, by letter on February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 6,246 units. REASON Injury to patient's fingers may result when returning chair to upright position. ________ PRODUCT Pilot Model 9200 Vital Signs Monitor, used to measure blood pressure and heart rate non-invasively. Recall #Z-370-0. CODE Serial Numbers 000031 through 000077. MANUFACTURER Calin Corporation, Hayashi, Komaki City, Japan. RECALLED BY Colin Medical Instruments Corporation, San Antonio, Texas, by telephone beginning November 5, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Italy, Colombia, Japan. QUANTITY 46 units were distributed in the United States. REASON Leakage from a capacitor in the power supply would cause the power supply to fall. ________ PRODUCT Chiron Vision, Soflex Model C31UB, Intraocular Lens (IOL). Recall #Z-371-0. CODE Lot Numbers: 1015871 which is the 25.5 power diopter model; expires in July 2004; 1015835 which is the 15.0 power diopter model; expires in July 2004. The IOL'S also carry a serial number: 9920010620 9920010625 9920010630 9920010635 9920010621 9920010626 9920010631 9920010636 9920010622 9920010627 9920010632 9920010637 9920010623 9920010628 9920010633 9920010567 9920010624 9920010629 9920010634 9920010595 9920010596. MANUFACTURER Bausch & Lomb Surgical, Inc., Irvine, California. RECALLED BY Manufacturer, by telephone and by letter on December 22, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona, Florida, Indiana, Kentucky, Michigan, Minnesota, North Carolina, Ohio, Pennsylvania. QUANTITY 21 lenses were distributed. REASON The labels for lot 1015871 (25.5 diopter lenses) were switched with labels for lot 1015835 (15.0 diopter lenses), which resulted in refractive errors requiring explanation. ________ PRODUCT Fourex Natural Skin Condoms. Recall #Z-374-0. CODE 443, 443P, 444, 444R, 446, 451, 451R, 452,452C, 452R, 462, 463. MANUFACTURER London International Group, PLC, Norcross, Georgia. RECALLED BY Manufacturer, by letter on December 13, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,016,146 units. REASON Products may exhibit objectionable odor, dried out or become brittle and unusable. ________ PRODUCT Castle Steam Sterilizers: (a) Chambers with Door cross-sections of 16"x16" and 20"x20" - Sentry models #s 200/212/220/230, 3020, 3012, 3022, 3023, 3025, 3120, 3122, 3123, 3125, 3130, 3133, 3322, 3323, 3325, 3333, 3522, 3523, 3525, 3533; (b) Chambers with door cross-sections of 24"x36" and 26" x 36" - Model #s 3220, 3222, 3223, 3230, 3233, 3422, 3423, 3433, 3622, 3633, 3641 (c) Chambers with door cross-sections of 26"x62" - Model #s 4030, 4033, 4133, 4233. Recall #Z-375/377-0. CODE All codes. MANUFACTURER Getinge/Castle, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter dated October 12, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 13,300 in operation, 4,750 with steam generator attachments. REASON Under certain conditions, hot water may enter the chamber, resulting in serious risk of burn injury when the chamber door is opened. ________ PRODUCT STIC-KIT, needle/sharps containment system, packaged as 6 units/card and shrink-wrapped, used primarily by Para-Medical Services, including EMTs, as part of their First Response Kit. Recall #Z-378-0. CODE Catalog #EM82691. All Lots manufactured and distributed since October 26, 1998 beginning with '10 28 98'. MANUFACTURER Kohlbrat & Bunz Corporation, Mooresville, North Carolina. RECALLED BY E.M. Innovations, Inc., Kent, Ohio, by fax on January 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Missouri, Florida, New Hampshire, Arizona, Wisconsin, California, South Carolina, Oregon, New York, Alaska. QUANTITY 244 units. REASON Needles/sharps may penetrate through container wall and stick healthcare worker. ________ PRODUCT Allograft Heart Valves Model PVOO and Model AVOO. Recall #Z-379/380-0. CODE Model Number PV00 - Serial Number 3874818 Model Number AV00 - Serial Number 3874826 Model Number AV00 - Serial Number 6094996 Model Number PV00 - Serial Number 6095003. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on February 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Michigan, Pennsylvania, California. QUANTITY 4 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT a) Bard Biopty-Cut Biopsy Needle; b) Bard Biopty-Cut Needle with Spacer. Recall #Z-348/349-0. CODE Lot Numbers: a) 22JJ1105, 22JJ1135; 22IJ0925. MANUFACTURER Bard Reynosa, S.S. de C.V., Reynosa, Mexico. RECALLED BY Bard Peropheral Technologies, C.R. Bard, Inc., Covington, Georgia, by telephone and letter on September 29, 1999. Firm- initiated recall ongoing. DISTRIBUTION Arkansas, California, Florida, Illinois, Indiana, Kentucky, Mississippi, Missouri, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, West Virginia, Wisconsin, Australia, Belgium. QUANTITY Firm estimated that 1,052 units remained on market at time of recall initiation. REASON Product is labeled as a Bard Biopty-Cut Needle, 18 gauge x 16cm long but contains a Bard Biopty-Cut Needle, 18 gauge x 20 cm long. ________ PRODUCT Corning Calcium pH analyzer 634, intended for the measurement of pH and ionized calcium in whole blood. Recall #Z-350-0. CODE Model 634 Reagent Pack, Part #478548. Lot Numbers: 9F001 EXP 4/30/01, 9G010 EXP 5/31/01. MANUFACTURER Bayer Diagnostics, Sudbury, Suffolk, England. RECALLED BY Manufacturer by telephone beginning on December 24, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 127 packs of lot #9F001. 204 packs of lot #9G10 at 4 bottles per pack. REASON Pseudomonas aeruginosa contamination causing increase in quality control values of pH. ________ PRODUCT Premier Giardia Diagnostic Test Kits, an enzyme immunoassay (EIA) for the detection of Giardia lamblia antigens in human stool. Recall #Z-357-0. CODE Lot #614096.012 EXP 5/2/2000. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter on January 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Germany and Italy. 478 kits were distributed. REASON Kits do not meet manufacturerís specifications due to design failure. _______ PRODUCT Abbott Vision Cholesterol TestPack, List #1415-10, 10 tests per package, Enzymatic Esterase - Oxidase, Cholesterol test pack used in the Abbott Vision System for the quantitative determination of cholesterol in anticoagulated whole blood, plasma or serum and are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Recall #Z-363-0. CODE Lot Numbers: 54166M200, 54476M300, 54477M300, 55603M100, 55604M100, 55857M300, 55858M300, 56015M300, 57226M100, 57227M100, 57228M100, 57761M100, 58048M100, 58049M100, 58641M200, 58642M200, 58741M400, 58742M400, 59365M300. MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois. RECALLED BY Abbott Laboratories Inc., Abbott Park, Illinois by letter dated January 31, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia, Taiwan, Singapore, Japan, Italy and Germany. QUANTITY 46,034 ten-packs were distributed. REASON ENDPOINT NOT REACHED error messages. ________ PRODUCT LOFRICÆ CATH-Kit, a urinary catheter intended for intermittent urinary catherization. Recall #Z-368-0. CODE Product #92084; Lot #3418 EXP 12/02. MANUFACTURER Astra Tech AB, Molndale, Sweden. RECALLED BY Astra Tech, Inc., Lexington, Massachusetts, by letter on February 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Washington state. QUANTITY 560 units were distributed. REASON Catheter has no holes for drainage. ________ PRODUCT IMx Reaction Cells, list 8397-05; an accesssory device for use with the IMx Select Analyzer for MEIA assays; 100 cells per carton. Recall #Z-369-0. CODE Lot #54034M400. MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois. RECALLED BY Manufacturer, by letter dated February 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 5,490 boxes were distributed. REASON Manufacturing defect may result in inadequate flow of the reagents through the reaction cell. ________ PRODUCT Triage Cardiac Test Panel, Part #97000, an in-vitro diagnostic test kit intended to be used in a medical setting. Recall #Z-373-0. CODE Lot #W-17837B. MANUFACTURER Biosite Diagnostics, Inc., San Diego, California. RECALLED BY Manufacturer, by telephone on December 7 & 8, 1999. Firm- initiated recall ongoing. DISTRIBUTION Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Nebraska, New Jersey, Nevada, New York, South Carolina, Tennessee, Texas, Wisconsin. QUANTITY 112 kits were distributed. REASON The reagents were inadvertently switched between the test troughs, resulting in irreproducible and inconsistent test results. END OF ENFORCEMENT REPORT FOR FEBRUARY 23, 2000.
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