FDA

Enforcement Report

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


MARCH 27, 2002 02-12

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_______________________ PRODUCT Guida's 1% Lowfat Milk, packaged in a) 1-gallon plastic containers b) Half-pint wax paper containers. Labeled in part: Guida's pasteurized homogenized vitamin a & d 1%. Recall # F-326-2. CODE Code (expiration Date) Time Code a) Dec. 9, 2001 8:00 AM to 9:40 AM b) Dec. 8, 2001 no time code. RECALLING FIRM/MANUFACTURER Guida-Seibert Dairy Company, New Britain, CT, by telephone on between November 27 and 29, 2001. Firm initiated recall is complete. REASON Milk may contain undeclared egg yolks. VOLUME OF PRODUCT IN COMMERCE 4,000 Gallons and 39,750 1/2 pints. DISTRIBUTION NY, NJ, CT, RI and MA. _______________________ PRODUCT Product consists of cookies packaged in a clear plastic clamshell containing twelve (12) cookies, net weight of 12oz. Label ssaucedo@reads in part: "BROWN'S Sugarless Bakery FRUIT JUICE SWEETENED *** Oatmeal Spice Cookie ***INGREDIENTS: Whole Wheat Flour, Oats, Raisins, Fructose, Fruit Juice Concentrate, Margarine, Flour (White, Enriched, Unbleached), Spices, Baking Soda, Salt.***". Recall # F-327-2. CODE The 12 oz clamshell packages do not contain a code. However, the manufacturer recommends to the distributer a 7 day shelf life from the date of receipt at the retailer. The retailer decides whether to put a date on the cookies. All cookies manufactured and distributed prior to 1/4/02 are subject to this recall. RECALLING FIRM/MANUFACTURER Recalling Firm: Olson Baking Company Lynnwood, WA, by telephone and fax on January 7, 2002. Firm initiated recall is complete. REASON Product contains undeclared egg. VOLUME OF PRODUCT IN COMMERCE 6082 - 12 oz packages. DISTRIBUTION TX, FL, IL, DE, NJ, PA, MD, CA, OR, WA, ID and MT.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

*****CORRECTION*****

Recall # F-320-2 on Enforcement Report 02-10 was listed as ongoing. It is complete. _______________________ PRODUCT a) Robert’s American Gourmet Pirate’s Booty with Aged White Cheddar, Puffed Rice and Corn!, net wt. 4 oz. (112 g). Pirate's Booty: barcode # 15665 60100 Ingredients: Rice, Corn Meal, Canola Oil, Aged Cheddar Cheese, (No Fat Milk, Salt, Cheese Cultures, Enzymes), Whey, and Lowfat Buttermilk. Dist. by Robert’s American Gourmet, Sea Cliff, NY. Recall # F-328-2; b) Robert’s American Gourmet Fruity Booty with Papaya and Mango*, Puffed Rice and Corn!, Net wt. 4 oz. (113 g). *Part of a 10 fruit blend. Fruity Booty: barcode # 15665 60900 Ingredients: *Organic Rice, Corn, Organic Soy Flour, Expeller Pressed Canola Oil, (Whole Food Concentrates), Papaya, Mango, Orange, Cherry, Raspberry, Blackberry, Strawberry, Pineapple, Grape, Apple, Pectin, and Sea Salt. Created and Distributed by Robert’s American Gourmet, Sea Cliff, NY. Recall # F-329-2; c) Robert’s American Gourmet Veggie Booty with concentrated Spinach & Kale, Puffed Rice and Corn!, Net wt. 4 oz. (113 g). Ingredients: *Organic Rice, Corn, Organic Soybean Flour, Expeller Pressed Canola Oil, (Whole Food Concentrates) Spinach, Kale, Cabbage, Carrot, Broccoli, Green Tea, Parsley, and Sea Salt. Veggie Booty: barcode # 15665 60915. Created and Distributed by Robert’s American Gourmet, Roslyn Heights, NY. Recall # F-330-2. CODE Sell by Dates: all products before "June 11, 02". RECALLING FIRM/MANUFACTURER Recalling Firm: Robert’s American Gourmet Foods, Inc., Sea Cliff, NY, by letter dated December 24, 2001. Manufacturer: Keystone Foods Easton, PA. FDA initiated recall is ongoing. REASON The products' nutrition facts panel contained incorrect values. VOLUME OF PRODUCT IN COMMERCE a) Pirate’s Booty: 2000/4 oz. bags; b) Fruity Booty: 100/4 oz. bags; c) Veggie Booty: 100/4 oz. Bags. DISTRIBUTION Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

_______________________ PRODUCT Weider's Eyedrops (Aloeflex) NET WT. 1 fl. oz. (Aloe Vera juice). Recall # D-205-2. CODE Product is not coded, or if coded, coding is unknown. All codes were recalled. RECALLING FIRM/MANUFACTURER Recalling Firm: Aloe Flex Enterprises, Dickinson, TX, by letter dated December 11. 2001; Manufacturer: Tennis Elbow Corporation, Dickinson, TX. FDA initiated recall is complete. REASON Microbial contamination (Acinetobacter calcoaceticus-baumannii). VOLUME OF PRODUCT IN COMMERCE 28. DISTRIBUTION TX. _______________________ PRODUCT SanPharma brand Mucor Drops 4X (Homeopathic Medicine eyedrop) 0.34 fl oz bottles. Recall # D-206-2. CODE 11 2003. RECALLING FIRM/MANUFACTURER BioResourse, Inc. Cotati, CA, by telephone on December 11, 2001. FDA initiated recall is ongoing. REASON Microbial contamination (Stenotrophomonas maltophilia). VOLUME OF PRODUCT IN COMMERCE 55 (+) bottles. DISTRIBUTION CA and WI, ID, NM, MT, MI, CO, FL, TX, WA, and HI. _______________________ PRODUCT Pharmacy compounded Inhalation solutions in 3 mL plastic squeeze dispensers as follows: a) Albuterol 2.5 mg/Ipratropium 0.5 mg/Dexamethasone 0.4 mg/3ml, Recall # D-207-2; b) Albuterol 2.0 mg/Ipratropium 0.5 mg/3ml, Recall # D-208-2; c) Albuterol 2.5 mg/Cromolyn 20 mg/3ml, Recall # D-209-2; d) Albuterol 1.0 mg/Ipratropium 0.5 mg/3ml, Recall # D-210-2; e) Albuterol 5.0 mg/Ipratropium 0.5 mg/3ml. Recall # D-211-2. CODE a) Lot: 112001BAID; b) Lot: 112601CAI; c) Lot: 112601LAC; d) Lot: 112601NAI; e) Lot: 112801DAI. RECALLING FIRM/MANUFACTURER Med-Mart Pharmacy, Bakersfield, CA, by telephone on December 10 and by letters on December 27, 2001. FDA initiated recall is ongoing. REASON Microbial contamination (Serratia species bacteria). VOLUME OF PRODUCT IN COMMERCE 4,200 units. DISTRIBUTION CA and CO.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________ PRODUCT Eye-Saver Concentrate, Sodium Chloride(eye wash), plastic bottles, 121.5 fl. oz. (0.95 gallons) per bottle, 1/case, packaged under the SPEAKMAN brand label. Recall # D-213-2. CODE All lot numbers are recalled. RECALLING FIRM/MANUFACTURER Chester Labs, Inc., Cincinnati, OH, by fax on February 22 and 26, 2002. FDA initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 50,346 cases (bottles). DISTRIBUTION DE. _______________________ PRODUCT Exelon Capsules (rivastigmine tartrate), 4.5 mg, 60 capsule bottles, Rx Only, labeled as Manufactured by: Novartis Famaceutica, S.A. Barcelona, Spain for Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. Recall # D-215-2. CODE Lot 115D1784, expiration date 12/2004 NDC 0078-0325-44. RECALLING FIRM/MANUFACTURER Recalling Firm: Novartis Pharmaceuticals Corporation, Suffern, NY, by letter on February 27, 2002. Manufacturer: Novartis Pharma AG Stein, Switzerland. Firm initiated recall is ongoing. REASON Mis-packaging - (3.0mg capsule in 4.5 mg labeled bottle). VOLUME OF PRODUCT IN COMMERCE 10,069 bottles. DISTRIBUTION Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________ PRODUCT Allegra (fexofenadine hydrochloride) Tablets, 60-mg., 100-ct. bottles packaged in 24-bottle shipping containers, RX, NDC 0088- 1107-47. The responsible firm on the label is Aventis Pharmaceuticals Inc., Kansas City, MO. This recall is being extended to add two additional lot numbers -1038814 and 0138816. Recall # D-038-2. CODE 1038814, Exp. Dec. 26, 2003 1038816, Exp. Dec. 26, 2003 1038818, Exp. Dec. 27, 2003 1039714, Exp. Feb. 6, 2004 1039715, Exp. Feb. 6, 2004. RECALLING FIRM/MANUFACTURER Aventis Pharmaceuticals, Inc., Kansas City, MO, by letter dated September 27, 2001. Firm initiated recall is complete. REASON Mis-labeling - Shipping carton bears incorrect NDC Bar code. VOLUME OF PRODUCT IN COMMERCE 79,049/100-ct. bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Allegra tablets (fexofenadine HCl) 60 mg., 2-tablet blister packages (30-ct. boxes)physician samples, Rx Only The responsible firm on the label is Aventis Pharmaceuticals Inc., Kansas City, MO. Recall # D-212-2. CODE Lot 1027124, exp. 2/3/03 Lot 1027842, exp. 2/3/03 Lot 1028789, exp. 2/4/03. RECALLING FIRM/MANUFACTURER Aventis Pharmaceuticals, Inc. Kansas City, MO, by e-mail dated July 3, 2001. FDA initiated recall is complete. REASON Product was not manufactured in conformance with its New Drug Application (NDA) specifications, lacking particle size and friability testing VOLUME OF PRODUCT IN COMMERCE 117,071/30-ct. boxes. DISTRIBUTION Nationwide. _______________________ PRODUCT Compazine tablets 5 mg (Prochloperazine), bottles of 100 tablets and blister packages of 100 tablets (2x5 blister cards), SmithKline Beecham Pharmaceuticals, Philadelphia, PA. Recall # D-214-2. CODE Lot No. Exp. Date 12-1C66J 10/31/03 F12-1C66 10/31/03. RECALLING FIRM/MANUFACTURER SKB Pharmaceutical Co Cidra, Puerto Rico, by letters dated March 15, 2002. Firm initiated recall is ongoing. REASON Subpotent VOLUME OF PRODUCT IN COMMERCE 13,025 bottles of 100 tabs and 2,400 ctns 100's DISTRIBUTION Nationwide. _______________________ PRODUCT Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg, Rx Only, Ayerst Laboratories, Inc., Philadelphia, PA. Recall # D-216-2. Bottles of 100 - NDC #0046-0867-81 Bottles of 1000 - NDC #0046-0867-91 Bottles of 5000 - NDC #0046-0867-95. CODE Lot Numbers: 9001566, exp. 07/03 9010254, exp. 07/03 9010255, exp. 07/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA, by letters dated February 21, 2002. Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failure to meet dissolution specifications. VOLUME OF PRODUCT IN COMMERCE 47,024 btls of 100; 9,255 btls of 1000; and 1,408 btls of 5000. DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

_______________________ PRODUCT Red Blood Cells, Recall # B-0920-2. CODE Unit 9893665. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone on March 20, 2001. Firm initiated recall is complete. REASON Blood product, which tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), positive by confirmatory (neutralization) test for HBsAg, and repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________ PRODUCT a) Red Blood Cells, Recall # B-0921-2; b) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-0922-2. CODE a) 9893652; b) 9890623. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone on March 20, 2001. Firm initiated recall is complete. REASON Blood products, which tested repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION LA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________ PRODUCT Immune Globulin Intravenous (Human); Venoglobulin?-S, 10% Solution; (10 g, 100 ml). Recall # B-0858-2. CODE Lot number GR1038A. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, CA, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Human immunoglobulin, with anti-complementary activity (ACA) levels that exceeded specifications, were distributed. VOLUME OF PRODUCT IN COMMERCE 1,351 vials. DISTRIBUTION FL and GA. _______________________ PRODUCT Ragweed Mix - Giant/Short, Allergenic Extract, 50 milliliter bottle, 20,000 PNU/ml, Recall # B-0904-2. CODE Lot number D1021465. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by letter dated December 10, 2001. Firm initiated recall is complete. REASON Allergenic extract, labeled with an incorrectly low antigen E concentration, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION PA.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

_______________________ PRODUCT Brand name: Olympus Bronchoscope 15 Model Numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160. Common name: Video Bronchoscope Classification name: Bronchoscope (flexible or rigid). Recall # Z—573-2/Z-0587-2. CODE All serial numbers for the following 15 Model Numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF- 1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160. RECALLING FIRM/MANUFACTURER Recalling Firm: Olympus America Inc., Melville, NY, by letters dated November 30, 2001. Manufacturer: Olympus Optical Co., Ltd., Shinjuku-ku, Tokyo, Japan. Firm initiated recall is ongoing. REASON Loosened bronchoscope biopsy channel port & microbial contamination of the port. VOLUME OF PRODUCT IN COMMERCE 5157 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Various OB/GYN surgical devices labeled as sterile or processed by ETO. Recall # Z-0597-2. CODE All lots labeled as sterile. RECALLING FIRM/MANUFACTURER A & A Medical/Rocket USA, Alpharetta, GA, by letter on March 13, 2002. Firm initiated 24 hour alert. REASON GMP deficiencies. VOLUME OF PRODUCT IN COMMERCE Unknown at this time. DISTRIBUTION Nationwide and Worldwide.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________ PRODUCT Intro-Flex Percutaneous Introducer Kits with AMC Thromboshield an Antimicrobial Heparin Coating. Size 8.5 F (Model 1652BF85H) and 6F (Model 1500F6). Recall # Z-0588-02/Z-0589-02. CODE Model 1500F6 Lot No. 951H0629 Exp. date 8/2003; Model 1652BF85H Lot No. 951H0609 Exp. Date 2/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Edwards Anasco, Puerto Rico, by telephone and fax December 5, 2001. Manufacturer: Edwards Lifesciences, LLC Anasco, Puerto Rico. Firm initiated recall is ongoing. REASON Product may have inadequate tray seal strength to ensure the sterility of the product for its stated life shelf. VOLUME OF PRODUCT IN COMMERCE 100 units. DISTRIBUTION MI, NJ, MD, ME and London and St Asaph. _______________________ PRODUCT Becton Dickinson's Directigen(tm) Flu A+B in-vitro diagnostic test kit, packaged in papercard boxes, each box containing instructions, reagents and controls to perform 20 tests. Recall # Z-0590-2. CODE 1058950 exp 6/21/2001 1061952 exp 10/15/2001 1081953 exp 11/12/2001 1056950 exp 11/12/2001 1066951 exp 11/12/2001 1073950 exp 10/26/2001 1073951 exp 11/12/2001 1086955 exp 11/12/2001 1121951 exp 11/12/2001 1173950 exp 11/13/2001 1193951 exp 12/17/2001 1263950 exp 2/18/2002 1263951 exp 2/18/2001 1263952 exp 2/18/2002 1276954 exp 2/18/2002 1276955 exp 2/18/2002 1276956 exp 3/13/2002 1276957 exp 3/13/2002 1276958 exp 3/13/2002 1288950 exp 3/13/2002 1281951 exp 3/13/2002 1295951 exp 3/13/2002 1295952 exp 3/13/2002 1302952 exp 3/13/2002 1309951 exp 3/13/2002 1309952 exp 3/16/2002 1309953 exp 4/19/2002 1309954 exp 4/19/2002 1309955 exp 4/19/2002 1318950 exp 6/01/2002 1318951 exp 6/01/2002 1318952 exp 6/01/2002 1318953 exp 6/01/2002. RECALLING FIRM/MANUFACTURER Becton Dickinson Diagnostic Systems, Sparks, MD, by urgent product recall notice on December 19, 2001. Firm initiated recall is ongoing. REASON Directigen (tm) test kit for Influenza may give false positive result. VOLUME OF PRODUCT IN COMMERCE 7853 kits. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) ANGIO-SEAL Vascular Closure Device 6F STS Platform, product re-order number 610110; b) ANGIO-SEAL 6F Vascular Closure Device, product re-order number 610092. Recall # Z-0592-2. CODE a) lots 01EJ50 and 01EC81; b) lot number 01EJ95. RECALLING FIRM/MANUFACTURER ST. Jude Medical, Inc., Daig Div., Minnetonka, MN, by firm representatives on February 7, 2002. Firm initiated recall is ongoing. REASON There are missing drip and blood inlet holes from the arteriotomy locator of some of the devices. VOLUME OF PRODUCT IN COMMERCE 7,800 units. DISTRIBUTION Nationwide. _______________________ PRODUCT BCI Handheld Pulse Oximeter, Catalog number 3303. Recall # Z-0593-2. CODE Serial Numbers: 390414715, 470346940, 702659223 - 702659228, 702659231 - 702659237, 702659239 - 702659242, 702659244, 702659246 - 702659256, 702659258 - 702659264, 702659266 - 702659282, 702659289 - 702659291, 702659293 - 702659296, 702659299, 702783001, 702783002, 702783004 - 702783017, 702783020, 702783021, 702783023 - 702783026, 702783030, 702783033, 702784025, 702784026, 702784028, 702784030, 702784031, 702784033 – 702784036. RECALLING FIRM/MANUFACTURER Bci, Inc., Waukesha, WI, by recall notice on February 21, 2002. Firm initiated recall is ongoing. REASON Inappropriate restart of the device can occur in about 10% of the devices if the audio alarm is set to the highest volume. Restart is a 2 minute period without alarms. VOLUME OF PRODUCT IN COMMERCE 99 units. DISTRIBUTION Nationwide and Brazil, Qatar and Saudi Arabia. _______________________ PRODUCT AEROSET System Software v1.00ER005.2 and v1.0ER005 Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2. CODE All Codes are affected by this field correction. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated December 7, 2001. Firm initiated recall is ongoing. REASON System may incorrectly associate sample ID & test requests under certain conditions of non-bar coded or unreadable bar coded samples. VOLUME OF PRODUCT IN COMMERCE 535. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Battery pack for the Criticare Multiple Parameter Telemetry MPT 2.4, Catalog Number 944-C. Recall # Z-0598-2. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Recalling Firm: Criticare Systems Inc., Waukesha, WI, by verbal notification on June 13 and October 18, 2001. Manufacturer: Badger Electronics, Franksville, WI. Firm initiated recall is ongoing. REASON Some of the battery packs overheat during use. The heat may melt the battery casing and device case. VOLUME OF PRODUCT IN COMMERCE 219 battery packs. DISTRIBUTION FL. _______________________ PRODUCT Survivalink FirstSave STAR Biphasic Automatic External Defibrillators, Model Numbers 9200, 9210, 9200D, & 9210D. Recall # Z-0599-2/Z-0602-2. CODE Serial Numbers Affected: 800067, 800076 - 800080, 800098 - 800105, 800107, 800109, 800111 - 800116, 800118, 800120 - 800121, 800125 - 800126, 800128, 800133, 800142, 800144, 800154 - 800155, 800159 -800160, 800162, 800210, 800427, 800448, 800456, 800462, 800481 - 800482, 800484 - 800487, 800489, 800491, 800495, 800497, 800499 - 800501, 800503 - 800504, 800527, 800540, 800542, 800560 - 800561, 800614, 800624 - 800625, 800638, 800748 - 800749, 800760, 800764, 800766 - 800768, 800793, 800806, 800810, 800826, 800850, 801197, 801292, 801394, 801564, 801571, 801580, 801591, 801593, 801602 -801603, 801605, 801613 - 801615, 801618 - 801620, 801628, 801665, 801679, 801951, 801994, 802443, 802536, 802547, 802550, 802632, 804091, 804324, 806441, 806457, 807047, 807505 - 807506, 807508, 807547, 807931, 808598, 808611, 809500, 809589, 809731, 809822, 810085, 811189, 812820, 812822, 812824, 812826, 812828, 812830, 812832 -812841, 813164, 813292, 813333, 813395, 813731, 813809, 813824, 813860, 813862, 814591, 814594, 814597, 814598, 814611, 814621 - 814630, 814633 - 814634, 814636, 814638 -814647, 814649, 814651 - 814652, 814654 - 814706, 814708 -814710, 814771, 814891 - 815187, 815189 - 815190, 815197, 815734, 815779, 815783, 815881 - 815910, 816211 - 816292, 816294 - 816360, 816380, 816408, 816411, 816417, 816420 - 816424, 816427 - 816428, 816430, 816433 - 816434, 816436, 816439, 816441 - 816442, 816444 - 816480, 816502, 816551, 816569, 816580, 816622, 816624, 816626, 816628, 816630, 816661 - 816780, 816819, 816828, 816866, 816894, 816904, 816915, 816931 - 817275, 817277 - 817452, 817454 - 817503, 817515, 817517 - 817526, 817528 - 817686, 817688 - 817745, 817747 - 817755, 817758 - 817760, 817763, 817764, 817766 - 817770, 817772, 817780, 817785, 817788, 817790, 817791, 817793, 817794, 817798, 817799, 817801 - 817817, 817819 - 817832, 817835 - 817842, 817845 - 817847, 817849 - 818098, 818100 - 818155, 818159 - 818217, 818219 - 818222, 818224 - 818228, 818230 - 818251, 818253 - 818256, 818258, 818260 - 818282, 818284 - 818288, 818290 - 818306, 818308 - 818332, 818334 - 818664, 818666 - 818699, 818701, 818702, 818704 - 818730, 818761 - 818885, 818887 - 818934, 818936 - 818957, 818959 - 818964, 818966 - 819018, 819020 - 819030, 819032, 819033, 819035 - 819044, 819046 - 819064, 819066 - 819067, 819069, 819070, 819077, 819079 - 819081, 819083 – 819090, 819121 - 819150, 819301 - 819359, 819361 - 819393, 819395 - 819411, 819413 - 819421, 819423 - 819464, 819466 - 819493, 819495 – 819529, 819531 - 819559, 819561 - 819575, 819577 - 819592, 819594 - 819598, 819601, 819603 - 819605, 819661 - 819723, 819725 - 819735, 819752, 819961 - 819990, 820651 - 820676, 820678 - 820710. RECALLING FIRM/MANUFACTURER Survivalink Corp., Minneapolis, MN, by letter dated October 24, 2001. Firm initiated recall is ongoing. REASON Product could fail to deliver defribrillation shocks. VOLUME OF PRODUCT IN COMMERCE 3,440 units. DISTRIBUTION Nationwide and International. ______________________ PRODUCT TotalCare treatment beds, as follows: a) Hill-Rom brand TotalCare beds. b) Hill-Rom brand TotalCare SpO2RT beds Recall # Z-0627-2/0628-2. CODE All Model P1900 TotalCare units distributed prior to December 5, 2000. RECALLING FIRM/MANUFACTURER HILL-ROM, Inc., Batesville, IN, by letter dated January 30, 2002. Firm initiated recall is ongoing. REASON Unintentional movement of bed or failure of controls to operate. VOLUME OF PRODUCT IN COMMERCE 22,849. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Abbott Carbon Dioxide Calibrator, In-Vitro Diagnostic, Recall # Z-0635-2. CODE Lot numbers 71296M300 and 75689M200. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letter on January 17, 2002. Manufacturer: Microgenics, Fremont, CA. Firm initiated recall is ongoing. REASON Results run low. VOLUME OF PRODUCT IN COMMERCE 1079. DISTRIBUTION Nationwide and to Mexico, Columbia, Brazil, Canada, England, Singapore, Hong Kong, Trinidad, Barbados, Turkey and St. Lucia. _______________________ PRODUCT a) Bayer Immuno 1(R) System, Bayer(R) TESTpoint(TM) TROPONIN I CONTROLS. Recall # Z-0637-2; b) Bayer Immuno 1(TM) System Bayer SETpoint(TM) TROPONIN I CALIBRATORS. Recall # Z-0638-2. CODE a) Part Number T-03-4006-1, Lot V56149, exp. 6/22/02 b) Part Number T-03-3888-01, Lot V56982, exp. 6/30/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY. 0n/about January 30, 2002, Bayer sent a "Customer Bulletin" (#156B0007-01, Rev. A, 2002-01) to its customers via FedEx overnight. Manufacturer: Fisher Scientific, Middletown, VA. Firm initiated recall is ongoing. REASON Degradation of products under current storage conditions. VOLUME OF PRODUCT IN COMMERCE a) 151 units; b) 330. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT OrthoPAT Autotransfusion Set, Sterile Distributed by: Zimmer, Dover, OH. Recall # Z-0639-2. CODE Ref: 00255511506. Lot Numbers: J01191 and K01184. RECALLING FIRM/MANUFACTURER Haemonetics Corp., Braintree, MA, by letter on January 28, 2002. Firm initiated recall is ongoing. REASON Product's sterility maybe compromised as the sterilization dose was not adequate. VOLUME OF PRODUCT IN COMMERCE 834 units. DISTRIBUTION NC. _______________________ PRODUCT Brand Name: Bayer ADVIA(R) Centaur(TM) Rubella IgG Assay Common Name: A chemiluminescence test for determination of IgG antibodies to the Rubella virus (an in vitro diagnostic). Recall # Z-0640-2. CODE Catalog Number: 117710 Lot Numbers: 1090311 (expiration date 12/14/01) 1227712 (expiration date 07/19/02) 1356813 (expiration date 09/14/02). RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics Tarrytown, NY, by customer bulletin in November 2001. Manufacturer: Bayer Corporation, Business Group Diagnostics East Walpole, MA. Firm initiated recall is ongoing. REASON Use of assay for quantification of IgG antibodies may yield incorrect results. VOLUME OF PRODUCT IN COMMERCE 725 units. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Hill-Rom TotalCare SpO2RT pulmonary therapy bed system. Recall # Z-0642- 2. CODE All units manufactured as, or upgraded to, a SpO2RT unit prior to February 4, 2002. RECALLING FIRM/MANUFACTURER HILL-ROM, Inc., Batesville, IN, by letter dated February 20, 2002. Firm initiated recall is ongoing. REASON Siderails may stay up without latching into place. VOLUME OF PRODUCT IN COMMERCE 2,627 beds. DISTRIBUTION Nationwide, Canada and Japan. _______________________ PRODUCT Graham-Field brand Ultrasound Scanning Gel, packed in 1 gallon (128 oz.) plastic jugs, four (4) units per carton, packaged under the GRAHAM-FIELD private label. Recall # Z-0643-2. CODE Lot Numbers: 145557 and 134038. RECALLING FIRM/MANUFACTURER Chester Labs, Inc., Cincinnati, OH, by mail on January 11, 2002. Firm initiated recall is complete. REASON Products distributed prior to complete manufacturing process validation. The lots failed microbial specifications. VOLUME OF PRODUCT IN COMMERCE 26 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Anspach brand 2.15 X 22.0 mm Spiral Router. Recall # Z-0644-2. CODE Catalog Number A-CRN-S, lot number 51179197. RECALLING FIRM/MANUFACTURER The Anspach Effort, Inc., Palm Beach Gardens, FL by letter on January 26, 2001. Firm initiated recall is ongoing. REASON High speed cutters will not fit into the motor drill system. VOLUME OF PRODUCT IN COMMERCE 100. DISTRIBUTION CA, MT, HI, TX and FL and Korea, the United Kingdom, South Africa, the Netherlands and Syria. _______________________ PRODUCT LIGACLIP Extra Ligating Clip Cartridge, implantable, sterile, single patient use. Each cartridge contains 6 titanium ligating clips, individually packaged in a copolyester blister and heat- sealed with a Tyvek lid/pouch. Each sales unit/carton contains 36 cartridges. Size: Medium. Recall # Z-0650-2 CODE Lot Number: P4P81H Catalog/Item Number: LT200. RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon Endo-Surgery, Inc., Cincinnati, OH, by recall notices on February 12, 2002. Manufacturer: Ethicon LLP San Lorenzo, Puerto Rico. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised as evidenced by a loss of package integrity. VOLUME OF PRODUCT IN COMMERCE 81 sales units/cartons. DISTRIBUTION TX, NC, CT, CA, IL, MO, and KY and Netherlands, Uruguay, Korea, South Africa, Argentina, Australia, Spain, and Saudi Arabia. _______________________ PRODUCT SangStat brand Celsior™ Cold Storage Solution. Recall # Z-0651-2. CODE Batch numbers: CE031 CE032 CE033 CE032-1 CE032-2 Lot Number: CE032-2 was distributed in USA only. RECALLING FIRM/MANUFACTURER Sangstat Medical Corporation Fremont, CA, by telephone on February 8, 2002. Firm initiated recall is ongoing. REASON Product is contaminated with unknown black residue. VOLUME OF PRODUCT IN COMMERCE 3,020 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Arrow Spring Wire Guide 0.025" x 23 5/8". The catalog number is AW- 14725. Recall # Z-0653-2. CODE Lot # CF1091343. RECALLING FIRM/MANUFACTURER Recalling Firm: Arrow Intl., Inc., Reading, PA, by letter dated March 8, 2002. Manufacturer: Arrow Internacional de Mexico, S.A. DE C.V. COL. Panamericana, Chihuahua. Firm initiated recall is ongoing. REASON Mislabeled 0.025 when it is actually 0.035 diameter. VOLUME OF PRODUCT IN COMMERCE 35 units. DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________ PRODUCT Leonardo Workstation, Image processing system, Diagnostic imaging. Recall # Z-0439-2. CODE Siemens Part #5225128 Serial Numbers: 1010; 1020; 1032; 1033; 1036; 1039; 1042; 1049; 1050; 1052; 1059; 1202; 1204; 1220; 1221; 1228; 1229; 1231; 1232; 1234; 1239; 1240; 1242; 1259; 1262; 1271; 1272; 1275; 1280; 1282; 1284; 1285; 1287; 1291; 1295; 1296; 1297; 1298; 1301; 1304; 1305; 2003; 2048; 2050; 2051; 2053; 2057. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by notice on July 6, 2001. Manufacturer: Siemens AG Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing. REASON Partial X-Ray images being transmitted to other receiving workstations. VOLUME OF PRODUCT IN COMMERCE 47 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Renasol Liquid Bicarbonate Concentrate BC-1-L Part B in one gallon (3.78 liter) bottles. Centrasol Liquid Bicarbonate Concentrate MB-330-L Part B in one gallon (3.78 liter) bottles. Recall # Z-0591-2. CODE Lots 51G109, 40H107, 146H121, 147H121, 148H121, 149H121, 39H107, 51H108, 230H130, 231H130, 121H117, 109H116, 119H117, 111H116, and 108J117. RECALLING FIRM/MANUFACTURER Minntech Corp., Minneapolis, MN, by letter dated November 13, 2001. Firm initiated recall is ongoing. REASON Aureobasidium pullulans, a yeast that can form chains as a fungus, is in the recalled products. VOLUME OF PRODUCT IN COMMERCE 13365 cases (4 one-gallon bottles per case). DISTRIBUTION Nationwide. _______________________ PRODUCT a) ACOM.PC Angiographic X-ray System; b) Digital Image Communications System. Recall # Z-0603-2. CODE Siemens part number: a) ACOM.PC V3.0-4371105 b) Quantcor V4.0-4786898, 5915553, 5915579. Equipment Concerned: Product: Part No. Serial No. LVA V 4.0 single station 47 86 898 >=01439 LVA V 4.0 1x Floating 59 15 553 all LVA V 4.0 3x Floating 59 15 561 all LVA V 4.0 6x Floating 59 15 579 all LVA V 4.0 10x Floating 59 15 587 all. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in April 2001. Manufacturer: Siemens AG Medical Engineering, Forcheim, Germany. Firm initiated recall is complete. REASON Software problem in recording heights and weights. VOLUME OF PRODUCT IN COMMERCE 34. DISTRIBUTION Nationwide. _______________________ PRODUCT Renatron II, Renatron PA, and Renatron 100 Dialyzer Reprocessing System machines, and the Renaclear Dialyzer Cleaning system. Recall # Z- 0629-2/0631-2. CODE The serial numbers for the affected devices are identified below, following the device names. Renatron II Dialyzer Reprocessing System 14003 14488 14495 14525 14530 14595 14688 14706 14715 14723 Renatron PA Dialyzer Reprocessing System PA1873 PA1879 PA1882 Renatron 100 Dialyzer Reprocessing System 14334 14693 14695 14696 14699 14700 14717 14720 14721 14724 14739 Renaclear Dialyzer Cleaning System RC01125 RC01167. RECALLING FIRM/MANUFACTURER Minntech Corporation, Minneapolis, MN, by telephone beginning January 21, 2002. Firm initiated recall is ongoing. REASON The recalled devices have internal stainless steel valve components that may corrode. VOLUME OF PRODUCT IN COMMERCE 26 units. DISTRIBUTION Nationwide and Malaysia. _______________________ PRODUCT Abbott AxSYM System Solution 4 Line Diluent; 10 L cubitainers (bag in box); item no. 8A46-01; for in vitro diagnostic use; 0.1 M Phosphate Buffer with sodium azide preservative and antimicrobial agent; Abbott Laboratories, Abbott Park, IL. Recall # Z-0632-2. CODE Lot numbers 79809M101, 80072M200, 80074M200, 80075M200, 80296M100, 80300M100, 81013M300, 81014M300, 81022M300, 81023M300, 81024M300, 81025M300, 81026M300, 81027M300, 81028M300, 81029M300, 81030M300, 81038M300, 81040M300, 81041M300, 81241M100, 81242M100, 81243M100, 81244M100, 81621M100, 81827M300, 81830M300, 81831M300, 81832M300, 81839M300, 81840M300, 81841M300, 81843M300, 81844M300, 81845M300, 81846M300, 81851M300, 81852M300, 81854M300, 81855M300, 81856M300, 81857M300, 81858M300, 81860M300, 81861M300, 81862M300, 81865M300, 81868M300, 81869M300, 81870M300, 81871M300, 81872M300, 81873M300, and 81874M300. The lots expire between 11/10/03 and 12/19/03. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL, by letter dated January 11, 2002. Firm initiated recall is complete. REASON Line Diluent causes opiate assay controls out of range high. VOLUME OF PRODUCT IN COMMERCE 36,850 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Architect Prolactin Calibrators, list number 6C27-01; 2 - 4 mL bottles of calibrators per box; Abbott Laboratories, Diagnostics Division, Abbott Park, IL. Recall # Z-0633-2. CODE Lot numbers 75941M300 and 75941M301, both with expiraiton date 03/24/02. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL, by letter dated January 16, 2002. Firm initiated recall is ongoing. REASON Calibration failures. VOLUME OF PRODUCT IN COMMERCE 532 kits. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Clinitek 100 Software Kit. Recall # Z-0634-2. CODE Version 7.00. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Elkhart, IN, by telephone and fax on January 21, 2002. Manufacturer: Bayer Corporation, Mishawaka, IN. Firm initiated recall is ongoing. REASON False negative results when high concentrations of ketone exist. VOLUME OF PRODUCT IN COMMERCE 5. DISTRIBUTION CT, MD, MA, NY and TX. _______________________ PRODUCT Immulite Thyroid Autoantibody Control Module. Recall # Z-0636-2. CODE Expire May 31, 2003. RECALLING FIRM/MANUFACTURER Diagnostic Products Corp., Los Angeles, CA, by letter dated December 10, 2001. Firm initiated recall is ongoing. REASON Negative bias in control values. VOLUME OF PRODUCT IN COMMERCE 464. DISTRIBUTION Nationwide. _______________________ PRODUCT Brand Name: IL Test(TM) Cal 1 Solution Calibrator for use with IL Synthesis, 500 mL, for in vitro diagnostic use (only). (IL: Instrumentation Laboratory) Recall # Z-0641-2 CODE Part Number: 9833200 Lot Number: N0811766, expiration date 8/2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory Co., Lexington, MA, by letters on October 29, 2001. Manufacturer: Instrumentation Laboratory Co., Orangeburg, NY. Firm initiated recall is complete. REASON Elevated electrolyte values with lot N0811766. VOLUME OF PRODUCT IN COMMERCE 3,674 bottles. DISTRIBUTION Nationwide and Canada, Mexico and Italy. _______________________ PRODUCT DENT-X Image-X 70(R) Plus Intra-Oral X-Ray Imaging System, Intraoral Diagnostic X-Ray Unit With X-Mind(R) Timer Control, Catalog/Model Number 9992700100. 510(k)# K000551. The Installation, Operation & Service Manual (Part Number 897- 000001) is the affected component for this "Field Correction". Recall # Z-0645-2. CODE All Serial Numbers manufactured & distributed between May 26, 2000 and April 20, 2001. RECALLING FIRM/MANUFACTURER Recalling Firm: AFP Imaging Corp., Elmsford, NY, by bulletin dated April 23, 2001. Manufacturer: ARDET s.r.l. 20090, Buccinasco, MI. Firm initiated recall is complete. REASON Incorrect wiring instructions - connection for the line and neutral terminals were reversed. VOLUME OF PRODUCT IN COMMERCE 674 units. DISTRIBUTION Nationwide and Puerto Rico.
END OF ENFORCEMENT REPORT FOR MARCH 27, 2002
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