March 5, 2003 03-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_____________________________ PRODUCT 12-oz. bottles labeled as Two Lightful Blue Cheese Dressing, 6 bottles per case. The bottles actually contained Caesar Dressing, which contain anchovies. Recall # F-226-3. CODE Lot #08 03 03W, followed by a 4-digit number: 0015 through 0200; UPC #70200-51018. RECALLING FIRM/MANUFACTURER T Marzetti Company, Columbus, OH, by facsimile on January 15, 2003 and January 17, 2003. Firm initiated recall is complete. REASON The product contained undeclared powdered anchovies. VOLUME OF PRODUCT IN COMMERCE 1,065 cases (6,390 bottles). DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Macaroni Salad containing macaroni, salad dressing, red peppers, green peppers, celery, onions, mustard, sodium benzoate. The product is packaged in 10 ounce and 24 ounce plastic tubs with snap lids. Recall # F-228-3; b) Cole Slaw containing cabbage, slaw dressing, carrots, sugar, citric acid. The product is packaged in plastic tubs with a snap lid, net wt. 4 lbs. Recall # F-229-3; c) Pimento Cheese Spread containing salad dressing, cheese spread, pimentos, sweet red peppers, non fat dry milk solids, 0.1% sorbic acid added to retard spoilage. The product is packaged in plastic tubs with a snap lid, net wt. 4 lbs. Recall # F-230-3. CODE All codes until expiration date JAN 30 that do not have "contains eggs" written on the container. RECALLING FIRM/MANUFACTURER Kings Salad Company, Cookeville, IN, by posting a sign at the retail level on December 23, 2003 and on site visit on December 30, 2003. FDA initiated recall is complete. REASON a) Eggs are not declared as a sub-ingredient in salad dressing; b) Eggs are not declared as a sub-ingredient in slaw dressing; C) Eggs are not declared as a sub-ingredient in salad dressing. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION TN. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II _____________________________ PRODUCT Broccoli Salad containing broccoli, carrots, onions, celery, apples, raisins, nuts, sugar, mayonnaise and vinegar. The product is packaged in plastic tubs with a snap lid, net wt. 4 lbs. Recall #F-227-3. CODE All codes until expiration date JAN 30 that do not have 'contains eggs' written on the container. RECALLING FIRM/MANUFACTURER Kings Salad Company, Cookeville, IN, by posting a sign at the retail level on December 23, 2003 and on site visit on December 30, 2003. FDA initiated recall is complete. REASON Eggs are not declared as a sub-ingredient in mayonnaise. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION TN. ____________________________ PRODUCT a) Yogurt Coated Maltballs, packed in a clear, plastic bag under the brand name Snack Attack Yogurt Maltballs (5.5 oz. bags; 12 bags per case) and also sold in bulk as Yogurt Maltballs (5 lbs; 15 lbs). Recall # F-231-3. b) Carob Coated Maltballs, packed in a clear, plastic bag under the brand names Your Brand Carob Maltballs (16 oz. bags; 6 bags per case) and Snack Attack Carob Maltballs (5.5 oz. bags; 12 bags per case) and also sold in bulk as Carob Maltballs (5 lbs; 15 lbs). Recall # F-232-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER American Natural Snacks, Inc., St. Augustine, FL, by letter on June 14, 2002. FDA initiated recall is complete. REASON The products contained undeclared wheat flour. VOLUME OF PRODUCT IN COMMERCE a) 1439 cases of 5.5 oz, 1155 lbs of 15 lb. bulk bags and 1835 lbs of 5 lb bulk bags. b) 123 cases/16 oz., 1400 cases 5.5 oz, 2800 lbs/bulk 5 lbs bags and 6270 lbs bulk 15 lb bags. DISTRIBUTION Nationwide. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III _____________________________ PRODUCT Hunt's Tomatoes Sauce, Net Wt. 8 Oz. Recall # F-195-3. CODE Case Code: All with initial 4 digits "A26U". Additional character will indicate the hour of either J, K, L, M, N, O, P, R, or S. Can code: "A26U" on the top line; the second line will read SW2 or the second character can be either an X or Y instead of a W. RECALLING FIRM/MANUFACTURER Conagra Grocery Products Co., Irvine, CA, by letters on October 7, 2002. Firm initiated recall is ongoing. REASON The product is unfit for food due to being held in swollen cans. VOLUME OF PRODUCT IN COMMERCE 12,189 cases. DISTRIBUTION Nationwide and Mexico. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II _____________________________ PRODUCT Humalog Pen (insulin lispro injection, rDNA origin), U-100, 3 mL, 100 units per mL, disposable insulin delivery system. Rx only, NDC 0002-8725- 01 (HP-8725). Recall # D-112-3. CODE Lot FF2S19C, exp. August 1, 2004. RECALLING FIRM/MANUFACTURER Eli Lilly and Company, Indianapolis, IN., by letters dated December 5, 2002. Firm initiated recall ongoing. REASON Drug cartridges may be cracked or broken. VOLUME OF PRODUCT IN COMMERCE 12,825. DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Natural Nasal Decongestant with Echinacea & Valerian, Children's Nightime Cold Formula, Tom's of Maine, (Pseudoephedrine HCl) 15mg/teaspoon, Net 4 Fl oz bottles (112 mL), Cherry flavor, No Alcohol. Recall # D-142-3; b) Natural Nasal Decongestant with Echinacea, Children's Daytime Cold Formula, Tom's of Maine, (Pseudoephedrine HCl), 15mg/teaspoon, Net 4 Fl oz bottles, Cherry Flavor, No Alcohol. Recall # D-143-3. CODE All lots. RECALLING FIRM/MANUFACTURER Tom's Of Maine, Inc., Kennebunk, ME, by letter on December 5, 2002. Firm initiated recall ongoing. REASON Misbranded; dosing instructions for children ages 2 to 6 will provide excessive amounts of active ingredient. VOLUME OF PRODUCT IN COMMERCE a) 10,188; b) 6,788. DISTRIBUTION Nationwide. _____________________________ PRODUCT Toprol-XL (Metoprolol Succinate) Tablets, 100 mg., 90 tablet bottles, each extended release tablet contains 95 mg metoprolol succinate equivalent to 100 mg metoprolol tartrate, USP; NDC #0339-5783-11. Recall # D-152-3. CODE LN066233, expires 12/19/03. RECALLING FIRM/MANUFACTURER Caremark Pharmaceutical Services, Vernon Hills, IL, by telephone and letters on January 8, 2003. Firm initiated recall is ongoing. REASON Mislabeling; bottles labeled as containing 100 mg tablets actually contain Toprol XL, 50 mg. Tablets. VOLUME OF PRODUCT IN COMMERCE 418 bottles. DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Fluoracaine, Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution USP, Sterile, Rx Only, Active : Fluorescein Sodium 0.25%, Proparacaine Hydrochloride 0.5% ; 5 mL glass screw cap vial with black propylene cap and sterile dropper. Recall # D-155-3; b) Fluress, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP; Sterile , Active: Fluorescein Sodium 0.25%, Benoxinate Hydrochloride 0.4%, 5 mL glass screw cap vial with black propylene cap and sterile dropper. Recall # D-156-3. CODE a) Lot numbers 31061, exp. 3/03; 51121, exp. 5/03; 81051, exp. 8/03; 11302, exp. 1/04; 51222, exp. 5/04, NDC # 17478-311-10; b) Lot numbers 81211, exp. 2/03; 91181, exp. 3/03; 121271, exp. 6/03; 11392, exp. 7/03; 21042, exp. 8/03; 21052, exp. 8/03; 41422, exp. 10/03; 51062, exp. 11/03. RECALLING FIRM/MANUFACTURER Akorn, Inc., Decatur, IL, by letter dated January 14, 2003. Firm initiated recall ongoing. REASON Container/closure integrity problems; leaking containers. VOLUME OF PRODUCT IN COMMERCE a) 129,594 bottles; b) 222,400 bottles. DISTRIBUTION Nationwide, Bahamas, Israel, the Phillipines, Canada and Australia. _____________________________ PRODUCT GEMZAR for Injection, (Gemcitabine HCl), 200 mg, For I.V. use only, 10 mL Sterile Single Use Vial, Lilly, Rx Only, Vial No. 7501. Recall # D-157- 3. CODE Lot 6MH15. RECALLING FIRM/MANUFACTURER Eli Lilly & Company, Indianapolis, IN, by letter on or about December 20, 2002. Firm initiated recall ongoing. REASON Container Defect: glass in vials. VOLUME OF PRODUCT IN COMMERCE 31,200 vials. DISTRIBUTION Agentina, Brazil, Columbia, Mexico, Taiwan and Venezuela. _____________________________ PRODUCT ONXOL injection (paclitaxel), 300 mg/50 mL (6mg/mL), 50 mL Multi Dose Vial, Rx only. Recall # D-161-3. CODE M026861 Exp Date 02/04. RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami, FL, by letter on January 20, 2003. Firm initiated recall ongoing. REASON Lack of assurance of sterility: Environment in Class 100 Filling room exceeded the non-viable particulate limit specification. VOLUME OF PRODUCT IN COMMERCE 1,039 vials. DISTRIBUTION Nationwide. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III _____________________________ PRODUCT Levothyroxine Sodium, USP, Tablets, 100 mcg (0.1mg), Rx only, 100 and 1000 count bottles, Also sold under the Qualitest and URL brand labels. Recall # D-126-3. CODE Lot numbers: 0170120B (Vintage), 100 count bottle NDC# 0254-3914-28; 070120D (Vintage), 1000 count bottle NDC# 0254-3914-38; .070120A (URL), 100 count bottle NDC# 0677-0078-01; and 070120C (Qualitest) 100 count bottle NDC# 0603-4195-21. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC, by letter on July 10, 2002. Firm initiated recall complete. REASON Stability; product may not maintain potency through the labeled expiration date. VOLUME OF PRODUCT IN COMMERCE 1800 bottles, 070120A; 3600 bottles, 070120B; 6000 bottles, 070120C and 1768 bottles, 070120D. DISTRIBUTION Nationwide. _____________________________ PRODUCT Feen-A-Mint Tablets, Laxative, (Bisacodyl ) 5mg, 10 tablet carton. Recall # D-140-3. CODE 1-EGN-4, EXP 1/3. RECALLING FIRM/MANUFACTURER Schering-Plough HealthCare Products/DBA Bain deSoleil Co., Cleveland, TN, by letter dated December 10, 2002. Firm initiated recall ongoing. REASON Disintegration: failure due to tablet softening. VOLUME OF PRODUCT IN COMMERCE 109,728 packages. DISTRIBUTION Nationwide. _____________________________ PRODUCT Hydrocodone Bitartrate and Acetaminophen Tablets USP, (10/ 500 mg), Qualitest, Rx only, 1000 Tablet bottles, NDC 0603-3888-32. Recall # D- 141-3. CODE Lot # 142081A. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC, by letters on November 6, 2002. Firm initiated recall complete. REASON Tablet hardness failure. VOLUME OF PRODUCT IN COMMERCE 1459 bottles (1000 tablets per bottle). DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Natural Nasal Decongestant with Echinacea & Valerian, Adult Nightime Cold Formula, Tom's of Maine, (Pseudoephedrine HCl) 30mg/teaspoon, Liquid, Net 4 Fl oz (112ml) bottles, No Alcohol, Tom's of Maine, PO Box Kennebunk, ME. Recall # D-144-3; b) Natural Nasal Decongestant with Echinacea, Adult Daytime Cold Formula, (Pseudoephedrine HCl) 30mg/teaspoon, Tom's of Maine, Liquid, Net 4 Fl oz (112ml) bottles, No Alcohol, Tom's of Maine, PO Box Kennebunk, ME 04043. Recall # D-145.3. CODE All lots. RECALLING FIRM/MANUFACTURER Tom's of Maine, Inc., by letter on December 5, 2002. Firm initiated recall ongoing. REASON Misbranded; dosing instructions for adults/children 12 yrs & older will only provide half of the required amount of active ingredient. VOLUME OF PRODUCT IN COMMERCE a) 8,072; b) 19,738. DISTRIBUTION Nationwide. _____________________________ PRODUCT Diltia XT, Extended Release Capsules,(Diltiazem HCl Extended Release Capsules, USP), 120 mg, 100 and 1000 capsule bottles, Rx only. NDC 62037- 548-01(100's) and NDC 62037-548-10 (1000's). Recall # D-146-3. CODE 548B002A, 548B002B, 548B003A ,548B003B, 548B004, 548B005A , 548B005B, 548B006 thru 548B010, 548C001,548C002A ,548C002B, 548C003, 548C004A and 548C004B,548C005 through 548C011A, 548C012C,548C012D, 548C013B and 548C014A. RECALLING FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on November 27, 2002. Firm initiated recall ongoing. REASON Dissolution Failure: four hour time point (12 month stability station). VOLUME OF PRODUCT IN COMMERCE 132,181 100's and 6,080 1000's. DISTRIBUTION Nationwide. _____________________________ PRODUCT Micardis Tablets, (telmisartan) 20 mg, 28 tablets, 4 blister cards of 7 tablets each, Rx only, NDC #00597-0039-28. Recall # D-148-3. CODE Lot #106909A, Exp 11/2003; and Lot #205752A, Exp 08/2004. RECALLING FIRM/MANUFACTURER Recalling Firm: Boehringer Ingelheim Roxane Laboratories, Columbus, OH, by letter on December 9, 2002. Manufactured: Boehringer Ingelheim Pharma KG, Ingelheim Germany. Firm initiated recall ongoing. REASON Container defect: loss of integrity of the air tight seal on the blister cards. VOLUME OF PRODUCT IN COMMERCE 264 boxes (73 - lot 106909A; and 191- lot 205752A). DISTRIBUTION Nationwide. _____________________________ PRODUCT a) Motrin IB (Ibuprofen tablets USP), 200mg, Coated Caplets, 2 count single dose packets, McNeil-PPC, Inc., Fort Washington, PA. NDC 50580-110-52. Recall # D-149-3. b) DayQuil LiquiCaps (Acetaminophen 250mg, Dextromethorphan HBr 10mg and Pseudoephedrine HCl 30mg) 2 count unit dose packages, Handy Solutions, A Trademark of Navajo Mfg., Co., Inc., Denver, CO. Manufactured by: Procter & Gamble, Cincinnati, OH. Recall # D-150-3. CODE a) and b) Lot No. FCC035, Exp. 03/05. RECALLING FIRM/MANUFACTURER Navajo Manufacturing Company, Inc., Denver, CO, by e-mail or telephone on November 22, 2002. Firm initiated recall ongoing. REASON Mispackaged by Recaller; packets of Motrin IB were incorrectly repackaged in hanging card packages labeled to contain DayQuil LiquiCaps. VOLUME OF PRODUCT IN COMMERCE Approx. 1470 units. DISTRIBUTION Nationwide. _____________________________ PRODUCT Ketoprofen, U.S.P., bulk pharmaceutical powder, CAS 22071-15-4, 5 g, 25 g, 100 g and 1Kg containers, Rx only. Recall # D-151-3. CODE Lots QK1162, QW0807. RECALLING FIRM/MANUFACTURER Spectrum Laboratory Products Inc., Gardena, CA, by letter on December 19, 2002. FDA initiated recall ongoing. REASON Failed individual impurity limits testing. VOLUME OF PRODUCT IN COMMERCE 7,734 - 1 oz. bottles and 6,315 - 2 oz. Bottles. DISTRIBUTION Nationwide. ___________________________ PRODUCT Clindamycin Phosphate Topical Solution, USP 1%, 1 oz. (30 mL) and 2 oz. (60 mL) plastic bottles, Rx Only, NDC 60432-693-30 (1 oz), 60432-693-60 (2 oz). Recall # D-154-3. CODE Lot number 24667, Expiration date 04/04; packaged as the following sub- lots 1 oz. bottles - sublot 24667A 2 oz. bottles - sublots 24667C and 24667E. RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letters dated January 17, 2003. Firm initiated recall ongoing. REASON Superpotency Clindamycin phosphate. VOLUME OF PRODUCT IN COMMERCE 7,734 - 1 oz. Bottles and 6,315 - 2 oz. Bottles. DISTRIBUTION PA, NY, MO, FL, OH, CA and Puerto Rico. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ___________________________ PRODUCT Steris Quick Connect (tethered) C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473. Recall # Z-0547-03. CODE Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473). RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH, by letter and fax on February 21, 2003. Firm initiated recall ongoing. REASON The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle. VOLUME OF PRODUCT IN COMMERCE 1,140 units. DISTRIBUTION Nationwide and Internationally. ___________________________ PRODUCT Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001. Recall # Z-0559-03. CODE Lot numbers P010900 and P010957. RECALLING FIRM/MANUFACTURER Sulzer Spine-Tech, Minneapolis, MN, by letter dated January 17, 2003. Firm initiated recall ongoing. REASON The product may have a twisted or broken tip. VOLUME OF PRODUCT IN COMMERCE 14 instruments. DISTRIBUTION CA and MS. ___________________________ PRODUCT ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11. Catalog number PAB111. Recall # Z-0560-3. CODE Lot numbers: R20061A, R20429A, R21002A, and R21002002B. RECALLING FIRM/MANUFACTURER Ventana Medical Systems, Inc., Tucson, AZ, by letter on September 27, 2002. Firm initiated recall is complete. REASON Inappropriate staining of tissue specimen caused by decreased sensitivity with certain component of antibody cocktail. VOLUME OF PRODUCT IN COMMERCE 60. DISTRIBUTION Nationwide. ___________________________ PRODUCT Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915 . Recall # Z-0561-03. CODE Lot Number: 56003 Exp. Date : 7/2005. RECALLING FIRM/MANUFACTURER Boston Medical Products, Inc., Westborough, MA, by letter on January 22, 2003. Firm initiated recall is ongoing. REASON Product sterility may be compromised. VOLUME OF PRODUCT IN COMMERCE 267 units. DISTRIBUTION Nationwide. ___________________________ PRODUCT Prism 3000S and 3000XP Gamma Camera Systems. Recall # Z-0563-03. CODE All serial numbers of Models N210060 and N210335. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH, by a "Customer Advisory Notice" on January 23, 2003. Firm initiated recall ongoing. REASON The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient. VOLUME OF PRODUCT IN COMMERCE 311 units. DISTRIBUTION Nationwide and Internationally. ___________________________ PRODUCT a) Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System. Recall # Z-0566-03; b) Hip Prosthesis as a component of Primaloc Cementless/Collarless Hip System. Recall # Z-0567-03; c) Hip Prosthesis as a component of Primaloc Cemented Hip System. Recall # Z-0568-03; d) Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.) Recall # Z-0569-03; CODE a) Catalog # 112-0915, Lot # OD-18031, W003152, WO#003152. Catalog # 112-0917, Lot # OD-19103-1, OD-20567, W0#003109. Catalog # 112-1015, Lot # OD-19038, W0#003155. Catalog # 112-1017, Lot # OD-17403. Catalog # 112-1115, Lot # WO#003045. Catalog # 112-1117, Lot # OD-23210, OD-23211. Catalog # 112-1119, Lot # OD-23232. Catalog # 112-1217, Lot # OD-23206. Catalog # 112-1219, Lot # OD-23233. Catalog # 112-1221, Lot # OD-23252 Catalog # 112-1223, Lot # OD-17321, W003725, WO#003350. Catalog # 112-1319, Lot # OD-20572, OD-20867-1, OD-23234, OD-23234-1, OD-23246. Catalog # 112-1321, Lot # OD-23253. Catalog # 112-1421, Lot # OD-23248, OD-23248-1, OD-23251, OD-23251-1. Catalog # 112-1425, Lot # OD-21874. Catalog # 112-1623, Lot # OD-21147-1. Catalog # 112-1625, Lot # W0#003130, WO#003139. b) Catalog # 111-0917, Lot # OD-22372; Catalog # 111-1015, Lot # OD-21589, OD-21589-1; Catalog # 111-1017, Lot # OD-23209; Catalog # 111-1019, Lot # OD-23235; Catalog # 111-1115, Lot # OD-22050; Catalog # 111-1117, Lot # OD-23205, OD-23205-1, OD-23298; Catalog # 111-1119, Lot # OD-22846, W002952, OD-23222; Catalog # 111-1217, Lot # OD-23207, OD-23208, OD-23299; Catalog # 111-1219, Lot # OD-22847, OD-20859-1, OD-23230, OD-22847-1; Catalog # 111-1221, Lot # OD-23254, OD-23249; Catalog # 111-1223, Lot # OD-18165, W002524; Catalog # 111-1319, Lot # OD-23231, OD-23231-1; Catalog # 111-1321, Lot # OD-23247; Catalog # 111-1421, Lot # OD-23250, OD-23255; Catalog # 111-1423, Lot # OD-23256; Catalog # 111-1425, Lot # OD-20837-1, W002683; Catalog # 111-1625, Lot # OD-21873, OD-19626-1, OD-22537. c) Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602; Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221; Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194; Catalog # 114-1421, Lot # OD-17306, OD-17412; Catalog # 114-1623, Lot # W0#003264, W003614; d) Catalog # 115-1015, Lot # W016134, W017080; Catalog # 115-1319, Lot # W016434. RECALLING FIRM/MANUFACTURER Ortho Development Corporation, Draper, UT, by telephone and e-mail on December 26,2002. Firm initiated recall is ongoing. REASON Cleaning agent residue from packaging material was adhering to implantable hip stems. VOLUME OF PRODUCT IN COMMERCE a) 78; b) 105; c) 41; d) 14. DISTRIBUTION TX and Japan. ___________________________ PRODUCT a) Ear Loop Procedure Masks, for one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard Box (unit box). Made in China. Product is labeled with a Latex-free symbol that states "This product does not contain any natural rubber latex". Recall # Z-0572-03; b) Ear Loop Procedure Masks with plastic shield, for one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Made in China. Product is labeled with a Latex-free symbol that states "This product does not contain any natural rubber latex". Recall # Z-0573-03. CODE a) Lot Number 14929, Barcode # 16784 22012. b) Lot Number 14929, Barcode # 16784 22023. RECALLING FIRM/MANUFACTURER Dynarex Corporation, Orangeburg, NY, by letter on December 31, 2002. FDA initiated recall ongoing. REASON Product labeled as "latex free" but recent tests indicate that it contains minute amounts of latex. VOLUME OF PRODUCT IN COMMERCE a) 1937 cases; b) 396 cases. DISTRIBUTION Nationwide, Puerto Rico, and the Bahamas. ___________________________ PRODUCT Nobel Biocare Replace Select Radiographic Template, part number 30159. Recall # Z-0575-03. CODE No codes apply. All physicians need to ensure the template is replaced. RECALLING FIRM/MANUFACTURER Nobel Biocare USA, Inc., CA, by recall letter and web. Firm initiated recall is ongoing. REASON Misprinted radiographic template plates. Misprinted labeling. VOLUME OF PRODUCT IN COMMERCE Unspecified. DISTRIBUTION Nationwide and Internationally. ___________________________ PRODUCT Convertors three quarter sheet (Drape Sheet), catalog #29350. Individually packaged drapes, 20 packages per case. Recall # Z-0576-03. CODE Lot number 02LFRW95. RECALLING FIRM/MANUFACTURER Recalling Firm: Allegiance Healthcare, Corp., McGaw Park, IL, by letter dated January 22, 2003. Manufacturer: Allegiance Healthcare, Corp., El Paso, TX. Firm initiated recall is ongoing. REASON The product labeled as sterile had not been through its sterilzation cycle. VOLUME OF PRODUCT IN COMMERCE 320 drapes. DISTRIBUTION NJ, GA, WA, and FL. ___________________________ PRODUCT Surgisis peripheral vascular patch; catalog number C-VSLH-$S-lx10. Recall # Z-0577-03. CODE Lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402,SB102006 and SB102670. RECALLING FIRM/MANUFACTURER Cook Biotech, Inc., West Lafayette, IN, by visit on December 13 and 17, 2002. Firm initiated recall is complete. REASON Adverse events-suspected pseudoaneurysm. VOLUME OF PRODUCT IN COMMERCE 153. DISTRIBUTION IN. ___________________________ PRODUCT Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI. Recall #Z-0578-03. CODE Product No 10A0889-A01. RECALLING FIRM/MANUFACTURER Lifecor, Inc., Pittsburgh, PA, by telephone on January 10, 2003 and letters on January 17, 2003. Firm initiated recall ongoing. REASON Wires may break or pull out, causing device to malfunction. VOLUME OF PRODUCT IN COMMERCE 174 units. DISTRIBUTION Nationwide and Internationally. ___________________________ PRODUCT a) Gamma Drill 5.5x300mm. Recall # Z-0579-03; b) Gamma AO Drill 5.5x300mm. Recall # Z-0580-03; c) Gamma Drill Dia. 4.2x300mm. Recall # Z-0581-03; d) T2 3.5x130mm AO Drill Bit. Recall # Z-0582-03; e) T2 3.5x130mm Tri Flat Drill Bit. Recall # Z-0583-03; f) T2 4.2mmx130mm AO Drill Bit. Recall # Z-0584-03; g) T2 4.2mmx130mm Tri Flat Bit. Recall # Z-0585-03; CODE a) 1214-5300S -- Gamma Drill 5.5x300mm -- K400056; K412682; K423453; K451275; K467231; K469197; K494341; K494342; K508650; K516457; K526734; K533284; K542636; K548132; K553788; K553789; K562650; K562654; K573121; K573122; K579936; K579937; K579938; K619518; K622108; K622109; K637404; K641097; K653378; K665203; K665204; K665205; K678519; K679127; K713867; K713868; K714918; K714919; K714920; K714921; K714922; K714923; K714924; K714925; K714926; K717459; K717462; K721328; K724574; K732012; K732013; K733474; K748814; K748817; K753097; K753098; K774660; K775180; K784772; K784774; K784775; K821925; K829527; K829529; K834976; K957002. b) 1212-5300S -- Gamma AO Drill 5.5x300mm -- K626400; K626401; K626402; K821823; K821824. c) 1314-3042S Gamma Drill Dia. 4.2x300mm -- K602221; K624126; K67480; K740593; K810155; K929678; K966326. d) 1806-3550S T2 3.5x130mm AO Drill Bit -- K561203; K569685; K569686; K591212; K591213; K653373; K713876; K725975; K743641; K743642. e) 1806-3555S T2 3.5x130mm Tri Flat Drill Bit -- K569689; K591094; K591215. f) 1806-4280S T2 4.2mmx130mm AO Drill Bit -- K410511; K419243; K419247; K462304; K462306; K579531; K591907; K591914; K591927; K591937; K637448; K713209; K713210; K723426; K737377; K743644; K770908; K776715; K776716; K776717; K776720; K776721; K796725; K796726; K823858; K823859; K823860; K823861; K834973. g) 1806-4285S T2 4.2mmx130mm Tri Flat Bit -- K727627; K727628; K727630; K823224; K823225; K824691; K824692; K824693. RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ, by letters on January 20, 2003. Firm initiated recall is ongoing. REASON Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility. VOLUME OF PRODUCT IN COMMERCE a) 5062; b) 53; c) 12; d) 290; e) 27; f) 2344; g) 1. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
___________________________ PRODUCT Carton Label: "TDM Performance Verifier I"; 6x2 mL vials****Catalog Number 896 2540. Recall # Z-0557-03 CODE T3606, Exp 31 Mar 2004. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY, by letters dated December 18, 2002. Firm initiated recall is ongoing. REASON Cartons labeled "TDM Performance Verifier I" may contain TDM Performance Verified II. VOLUME OF PRODUCT IN COMMERCE 1,338 cartons. DISTRIBUTION Nationwide. ___________________________ PRODUCT Vitros Immunodiagnostic Products***Universal Wash Reagent***for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793. Recall # Z-0558-03. CODE Lot 5003, EXP. 12 September 2003. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY, by letters dated January 10, 2003. Firm initiated recall is ongoing. REASON Label printing irregularities on cartons and/or bottles. VOLUME OF PRODUCT IN COMMERCE 284 cartons/568 bottles. DISTRIBUTION Nationwide. ___________________________ PRODUCT Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is packaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box. Recall # Z-0562-03. CODE The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07; The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07. RECALLING FIRM/MANUFACTURER Symbiosis, Corporation, Miami, FL, by letters on September 3, 2002. Firm initiated recall is ongoing. REASON Product does not have the needle component as part of the jaw assembly. VOLUME OF PRODUCT IN COMMERCE 155 5-packs. DISTRIBUTION Nationwide. ___________________________ PRODUCT a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03; b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-0565-03. CODE a) All HomeChoice Systems with software versions 8.51 and 8.52; b) All HomeChoice PRO Systems with software versions 8.51 and 8.52. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated December 23, 2002. Manufacture: Baxter Healthcare, Corp., Largo, FL. Firm initiated recall is ongoing. REASON Potential for low ultrafiltrate volumes when using the Low Fill Mode during continuous cycling peritoneal dialysis (CCPD) therapy. VOLUME OF PRODUCT IN COMMERCE 12,667 units. DISTRIBUTION Nationwide and Internationally. ___________________________ PRODUCT Act 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter. Recall # Z-0570-03. CODE Not applicable. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter dated January 20, 2003. Firm initiated recall is ongoing. REASON Failure to cycle properly among samples. VOLUME OF PRODUCT IN COMMERCE 351. DISTRIBUTION Nationwide and Canada. ___________________________ PRODUCT Coulter LH 700 series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter. Recall # Z-0571-03. CODE In the LH 700 series, all serial numbers up to AE1088. In the GENS series, all instruments. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by visit starting December 10, 2002. Firm initiated recall is ongoing. REASON Device design allows for cross contamination to occur, possibly affecting assays and results reports. VOLUME OF PRODUCT IN COMMERCE 447. DISTRIBUTION Nationwide and Canada.END OF ENFORCEMENT REPORT FOR MARCH 5, 2003 ####
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