April 4, 2001 01-13RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: Cold Smoked Sea Bass, air-packed in cardboard boxes. Recall #F-313-1. CODE: SB 0110. MANUFACTURER: Haifa Smoked Fish Inc., Jamaica, NY. RECALLED BY: Manufacturer, by telephone and letter on 2/15/01. FDA-initiated recall complete. DISTRIBUTION: Rego Park, NY (Queens). QUANTITY: 231.4 lbs. REASON: The product was contaminated with Listeria monocytogenes. ________ PRODUCT: Tasty Cookie Brand Almond Chip Cookies. Recall #F-314-1. Tasty Cookie brand Chocolate-Chocolate Chip Cookies. Recall #F-315-1. Tasty Cookie brand Peanut Butter Chip Cookies. Recall #F-316-1. Tasty Cookie brand Vanilla Chip Cookies. Recall #F-317-1. The cookies were packaged in 6 oz. Plastic tubs. CODE: Product is not coded. Any package that does not list egg whites as an ingredient is subject to recall. MANUFACTURER (REPACKER): City Nut & Candy, Inc., Hollywood, FL. RECALLED BY: Manufacturer, by telephone and fax letter on 1-4-01, and by press release on 1/5/01. FDA initiated recall complete. DISTRIBUTION: Miami and Boca Raton, FL. QUANTITY: 72 packages of various cookies. REASON: The cookies contain undeclared egg whites. ________ PRODUCT: Red wax wedges of cheddar cheese: a) Labeled as Great Lakes Hoop Cheddar Natural Cheese, in random weights of about 18 ounces per retail package, distributed by Great Lakes Cheese, Inc., Hiram, OH Wisconsin; b) Labeled as Famous Brand Mild Cheddar Cheese, random weight (9-15 ounces per wedge), distributed by Northern Wisconsin Produce Co., Manitowoc, WI.; c) labeled only with the name "HOOP CHEDDAR CHEESE", an ingredient statement, and Nutrition Facts. There is no brand name or firm name and address on the package which is a retail package designed to have the label completed by the consignee after being received. The packages of cheese had random weights of about one pound. One wholesaler labeled retail packages of the cheese "KROGER RED WAX HOOP CHEESE" by a weight/price sticker added to the retail packages and bar code number 2-03969-00461-8. Recall #F-320-1. CODE: Cases with pack dates 07 12 00, 07 19 00, 08 14 00, 09 25 00, 09 27 00, 10 02 00, 10 25 00. The recalled pull dates of the product with pull dates are 01 19 01, 02 04 01, 02 06 01, 04 09 01, 04 25 01, 07 16 01, 07 28 01, and 08 05 01. MANUFACTURER OF BULK CHEESE: Hill and Valley Cheese, Inc., Cashton, WI. RECALLED BY: Kickapoo Valley Cheese Corp., Sherry, WI. by letter dated 11/1/00. Completed recall resulted from sample analysis and follow-up by the Wisconsin Department of Agriculture. DISTRIBUTION: Georgia, Oklahoma, and Wisconsin. QUANTITY: 7950 Twenty pound cases of wedges and 85 ten pound cases. REASON: The cheese wedges were manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination. ________ PRODUCT: All Green Kingdom Herbs products of the following varieties (listed with Latin name of botanical): a)Akebia Extract, (akebia trifoliata). Recall #F-321-1; b)Stephania Extract, (stephania tetrandra). Recall #F-322-1; c)Clematis (Chinese) Extract, (clematis chinensis). Recall #F-323-1; d)Virginia Snake Root Extract, (aristolochia serpentaria). Recall #F-324-1; e)Witch Hazel Formula, (containing Virginia Snake Root Extract, aristolochia serpentaria). Recall #F-325-1; f)PFC - custom made formula, (containing Virginia Snake Root Extract, aristolochia serpentaria). Recall #F-326-1; g)HPX - custom made formula, (containing Virginia Snake Root Extract, aristolochia serpentaria). Recall #F-327-1; h)Ligusticum & Green Tea Formula I, (containing asarum). Recall #F-328-1; i)Ligusticum & Green Tea Formula II, (containing asarum). Recall #F-329-1; j)Ligusticum & Green Tea Formula III, (containing asarum). Recall #F-330-1; k)Ligusticum & Green Tea Formula IV, (containing asarum). Recall #F-331-1; l)Ligusticum & Green Tea Formula V, (containing asarum). Recall #F-332-1; m)Minor Blue Dragon Combination, (containing asarum). Recall #F-333-1. CODES: All Lots. MANUFACTURER: Green Kingdom Herbs, Bay City, Michigan. RECALLED BY: Manufacturer, via telephone and certified mail on December 1, 2000, and by press release November 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan, Texas, Georgia, Indiana, Illinois, New York, California. QUANTITY: a) 3 (three) 4oz. Bottles; b) 3 (three) 8oz. Bottles; c) 3 (three) 4oz. Bottles; d) 12 (twelve) 1oz. bottles, 8 (eight) 4oz.bottles, 2 (two) eight oz. bottles, 1 (one) ½ gallon container; e) 2 (two) 1oz. Bottles; f) 37 gallons, 12 oz.; g) 13 gallons, 50 oz.; h) 3 (three) 1oz. bottles, 3 (three) 4oz. Bottles; i) 3 (three) 1oz. Bottles; j) 3 (three) 1oz. Bottles; k) 3 (three) 1oz. bottles, 1 (one) 4oz. Bottle; l) 4 (four) 1oz. bottles, 1 (one) 4oz. Bottle; m) 1(one) 4oz. Bottle. REASON: The products contain aristolochic acid, a potent carcinogen and nephrotoxin.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ________ PRODUCT: Kraft EasyMac Microwavable Single Servings Macaroni & Cheese Dinner; 3/4 cup individual serving laminate twin-packets, packaged in 6-count boxes - UPC 21000-67148, and 18-count boxes - UPC 21000-67149. Recall #F-306-1. CODE: Code Dates SEP-05-01 through SEP-26-01. These dates are followed by either a "1" or "2", then "XCN" and military time. MANUFACTURER: Cloud Corp., Des Plaines, IL RECALLED BY: Kraft Foods, Inc., Northfield, IL, by faxed/e-mailed on 2/6/01. Firm initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 142,181.5 case equivalents. REASON: The product is contaminated with a compressed air system lubricant. ________ PRODUCT: Icing Carrots (cake/candy decoration): a) Item 5609 (1000 icing carrots per pack); b) Item 5615 (500 icing carrots per pack). Recall #F-307-1. CODE: Lot #010200. MANUFACTURER: Stichler Products, Inc., Reading, PA. RECALLED BY: Manufacturer, by telephone and follow-up letter on 2/8/01. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: 60 (1000 pack) and 30 (50 pack). REASON: a) The label of item 5609 (1000 icing carrots per pack) failed to list FD&C Yellow No. 6 as an ingredient and incorrectly stated that the product contained FD&C Red No. 3. b) The label of item 5615 (500 icing carrots per pack) failed to list FD&C Yellow No. 5 and FD&C Blue No. 1 as ingredients. ________ PRODUCT: Asian Boy (EBQ) Tapioca Stick (Bot Khoai) in 3.85 (100 g) plastic bags. Recall #F-308-1. CODE: None. MANUFACTURER: M&N Co., Ho Chi Minh City, Vietnam RECALLED BY: BCN Trading, Inc., Brooklyn, NY, by letter dated 3/9/00 Completed recall resulted from sample analysis and follow-up by the New York State Dept. of Agriculture and Markets. DISTRIBUTION: NY, PA, MA, CT, NJ, and Washington DC. QUANTITY: 133 cases(50 - 100 g bags per case). REASON: The product contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5) and it contains an unapproved red color. ________ PRODUCT: Breath Mints in metal tin labeled in part "DENTIST RECOMMENDED MYNTZ!Sugar-Free Mouth Acid Neutralizing" Net Wt. 1.75 oz. Recall #F-310-1. CODE: 00807 THROUGH 00809 00815 THROUGH 00822 00910 THROUGH 00913 01019 THROUGH 01028 01101 THROUGH 01104 01137 THROUGH 01141 01216 THROUGH 01220 01237 THROUGH 01239 01241 THROUGH 01243 01245 THROUGH 01247 10147 THROUGH 10151 10228 THROUGH 10241 10302 THROUGH 10307. MANUFACTURER: Vitech America Corporation, Kent, WA. RECALLED BY: Manufacturer, by telephone on 3/8/01 and by letter on 3/15/01. FDA-initiated recall ongoing. DISTRIBUTION: Nationwide and Estonia. QUANTITY: 614,472/1.75 oz.tins. REASON: The product contains undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Dairymen's Lemon Flavor Diet Iced Tea in 1 pt. and 1/2 gallon containers. Recall #F-311-1. CODE: All Sell-By Dates from 2/9/01 through 3/28/01. MANUFACTURER: Oberlin Farms Dairy, Inc., Cleveland, OH. RECALLED BY: Manufacturer, by letter dated 2/9/01. FDA initiated recall complete. DISTRIBUTION: Ohio, Michigan & Pennsylvania. QUANTITY: 7000 GALLONS. REASON: The product contains aspartame but does not bear the warning statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" as required by 21CFR 172.804.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: (OTC) Aldroxicon II Double Strength antacid/anti-gas liquid, (Aluminum Hydroxide 400 mg, Magnesium Hydroxide 400 mg, Simethicone 40 mg), 30 mL screw cap tubes in units of 10 per box. Recall # D-147-1. CODE: Lot #10056. MANUFACTURER: York Pharmaceuticals, Kansas City, KS. RECALLED BY: Textilease Medlique, Wood Dale, IL., by telephone on 2/23/02. Firm-initiated recall ongoing. DISTRIBUTIONY: In Arizona, Texas, Illinois, Georgia, Louisiana, Ohio, Connecticut, Alabama, Wisconsin, and North Dakota. QUANTITY: 33 cartons of 10 tube each and 227 cartons of 50 tubes. REASON: The product exceeded the microbial limits for release. ________ PRODUCT: Vercuronium Bromide Injection, 10 mg, 1 mg/ml. Recall #D-149-1. CODE: Lot 99M090 Schein Pharmaceutical (NDC 0364-3061-33) Lot 99M130 Schein Pharmaceutical (NDC 0364-3062-33) Lot 99N140 American Pharmaceutical Partners (NDC 63323-414-10) MANUFACTURER: Steris Laboratories, Inc., Phoenix, AZ. RECALLED BY: Manufacturer, by letters on 02/12/01. Firm-initiated recall ongoiing. DISTRIBUTION: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, ME, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, Puerto Rico and Canada. QUANTITY: 36510 lot 99M090, 48150 lot 99M130, 47110 lot 99N140 REASON: Lack of Assurance of Sterility-filter validation. _________ PRODUCT: Liqui-Doss® liquid for constipation (Mineral Oil 13.5mL/15mL), 2 and 16 Fl. Oz. Bottles. Reecall #D-154-1. CODE: LOT NOS. 57-142, 57-144, 57-145, 57-152, 58-055, 58-057, 58-058, and 58-063. MANUFACTURER: Ferndale Laboratories, Inc., Ferndale, MI. RECALLED BY: Manufacturer, by letters on October 27, 1998 and January 1999. Firm-initiated recall complete. DISTRIBUTION: United States. QUANTITY: 28,564 bottles. REASON: Possible yeast contaminationRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: (Rx) Hydromorphone HCL Injection, USP, 4 mg/20mL (0.2 mg/mL), 20 mL vial. Recall #D-148-1. CODE: LOT NOS. SV000E0 and SV001E0, and SV002E0. MANUFACTURER: THE International Medication Systems LTD., South EL Monte, CA. RECALLED BY: Manufacturer, by certified letter on Dec. 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION: AL CO GA KY MI MS NY TN WA AZ CT IL LA MN NC OH TX WI CA FL IN MA MO NJ PA VA QUANTITY: 23,990 units. REASON: Stability; Failure to meet potency specification prior to Labeled expiry (Subpotency). ________ PRODUCT: (OTC) Maximum Strength Sinus Tablets (Acetaminophen 500 mg, Pseudoephedrine HCL 30mg, Chlorpheniramine Maleate 2 mg 24 counts. Recall #D-150-1. CODE: Lot RM0260 (Bulk Lot Numbers 9046800, 9046801, 9046545, 9046546, 9068812, 9070507, 9070505, 9082222, 9082226, 9082225, 9093966, 9105984, 9105986, 0022054). MANUFACTURER: Contract Pharmacal Corp., Hauppauge, NY. RECALLED BY: Leiner Health Products, Inc., Carson, CA. by letter on 1/15/01. Firm-initiated recall ongoing. DISTRIBUTION: AR and OH. QUANTITY: 883,493 units packaged with 798,580 units distributed. REASON: Subpotency and dissolution failures at 12 months of expiry. ________ PRODUCT: (Rx) Methyldopa Tablets, USP, 250 mg, 100 count bottles. Recall #D-151-1. CODE: LOT NO. 465-916, Exp. Date 6/02, Batch #1404. MANUFACTURER: Wyeth-Ayerst/Lederle, Pearl River, New York. RECALLED BY: ESI Lederle, Philadelphia, PA., by certified mail on 2/23/01. Firm-initiated recall ongoing. DISTRIBUTION: AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico. QUANTITY: 14,402 bottles of 100. REASON: Tablet Discoloration. ________ PRODUCT: Prax ® Lotion, (Pramoxine HCL 1%), 15 mL, physician samples. Recall #D-153-1. CODE: LOT NOS. 57-209A, 58-007, 58-203. MANUFACTURER: Ferndale Laboratories, Inc., Ferndale, MI. RECALLED BY: Manufacturer, by letters on April 2, 1999 and June 16, 1999. Firm-initiated recall complete. DISTRIBUTION: United States. QUANTITY: Not provided. REASON: Subpotency (at 12 month stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: Plasma, Cryo Reduced. Recall #B-616-1. CODE: Unit 65-46811. MANUFACTURER: Michigan Community Blood Centers, Grand Rapids, MI. RECALLED BY: Manufacturer, by telephone on October 9, 2000. Firm-intitiated recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit. REASON: Blood product, collected from a donor who had been deferred for having lived in the United Kingdom, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-822-1. CODE: Unit 53GL08668 MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by telephone on November 8, 2000. Firm-initiated recall complete. DISTRIBUTION: District of Columbia. QUANTITY: One unit. REASON: Blood product, collected from a donor with a history Of jaundice, was distributed. ________ PRODUCT: Source Plasma. Recall #B-823-1. CODE: Units LO075640, LO076606, LO076161. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Loraine, OH. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ., by facsimile on April 26, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: Three units. REASON: Blood products, that had elevated levels of alanine aminotransferase (ALT), were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-824-1. b) Platelets. Recall #B-825-1. c) Cryoprecipitate; Recall #B-826-1. d) Plasma, Cryo-reduced. Recall #B-827-1. e) Recovered Plasma. Recall #B-828-1. CODE: a) Units 1668385, 1648441; b) Unit 1648441; c) Unit 1668385; d) Unit 1668385; e) Unit 1648441. MANUFACTURER: Central Kentucky Blood Center, Lexington, KY. RECALLED BY: Manufacturer, by letters or facsimile on December 4, 5 and 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Kentucky and New Jersey. QUANTITY: Six units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: Source Plasma. Recall #B-829-1. CODE: Units LO023979, LO024253, LO024424, LO024653, LO024829. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Loraine, OH. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ., by facsimile on December 3, 1997. Firm-initiated Recall complete. DISTRIBUTION: North Carolina QUANTITY: Five units. REASON: Blood products, collected from a donor who had been incarcerated, were distributed. ________ PRODUCT: Source Plasma. Recall #B-830-1. CODE: Unit 0410844821. MANUFACTURER: North American Biologicals, Inc., Oak Park, MI. RECALLED BY: North American Biologicals, Inc., Boca Raton, Fl., by letter dated June 7, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from a donor who had a tattoo within twelve months of donation, was distributed. ________ PRODUCT: Source Plasma. Recall B-831-1. CODE: LO024886, LO024986. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Loraine, OH. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ., by facsimile on December 3, 1997. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: Two units. REASON: Blood products, collected from a donor who had been incarcerated, were distributed. ________ PRODUCT: Pulmonary Hemi-artery, Model No. PH00. Recall #B-832-1. CODE: Serial numbers 3865517, 3865533. MANUFACTURER: CryoLife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letters dated November 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Georgia and Canada. QUANTITY: 2 units. REASON: Tissue for transplant was collected from a donor who had not been properly evaluated. ________ PRODUCT: Platelets Pheresis, Leukocyte Reduced. Recall #B-895-1. CODE: Unit 19241-6988. MANUFACTURER: United Blood Services, Reno, NV. RECALLED BY: Recalling Firm: Blood Systems, Inc., Scottsdale, AZ., by telephone on March 21, 2000, and by letter dated April 4, 2000. Firm-initiated recall complete. DISTRIBUTION: Nevada. QUANTITY: One unit. REASON: Blood product, collected from a donor who had lived in the United Kingdom from 1981 to 1983, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-901-1. CODE: Units FF39544, FF43170, FF43169. MANUFACTURER: Blood Centers of the Pacific, Peninsula South Bay, Burlingame, CA. RECALLED BY: Blood Centers of the Pacific, Irwin Center, San Francisco, CA., by letters dated September 14, 1998. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: Three units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-902-1. CODE: Unit FF49235. MANUFACTURER: Blood Centers of the Pacific, Peninsula South Bay, Burlingame,CA. RECALLED BY: Blood Centers of the Pacific, Irwin Center, San Francisco, CA., by letters dated August 28, 1998. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, collected from a donor who had a tattoo within twelve months of donation, was distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-914-1. CODE: Unit 01KX39985. MANUFACTURER: American Red Cross Services, Rochester, NY. RECALLED BY: American Red Cross Services, New York-Penn Region, West Henrietta, NY., by letter dated May 11, 2000. Firm-initiated recall complete. DISTRIBUTIONY: New York. QUANTITY: One unit. REASON: Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed. ________ PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall # B-947-1. CODE: Unit number 0337030. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by letter dated August 31, 2000. Firm-initiated recall complete. DISTRIBUTION: Washington. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-948-1; b) Platelets. Recall #B-949-1. CODE: a) and b) unit number 1250952. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO. RECALLED BY: Manufacturer, by letter dated July 24, 1998. Firm-initiated recall complete. DISTRIBUTION: Missouri. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-951-1; b) Recovered Plasma. Recall #B-952-1. CODE: a) and b) unit number 0340514. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by letters dated August 24, 2000, and September 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Washington and Florida. QUANTITY: Two units. REASON: Blood products, that tested negative for the antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2, were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: a) Red Blood Cells. Recall # B-820-1; b) Platelets. Recall #B-821-1. CODE: a)and b) Unit G07461. MANUFACTURER: Northern Illinois Blood Bank, Inc, Rockford, IL. RECALLED BY: Manufacturer, by telephone and letters on September 29, 2000. Firm-initiated recall complete. DISTRIBUTIONY: Illinois. QUANTITY: Two units. REASON: Blood products, collected from a donor with a history of hemochromatosis, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-905-1. CODE: Unit 54KH23843. MANUFACTURER: American Red Cross Blood Services, Puerto Rico Region, Rio Piedras. RECALLED BY: American Red Cross Blood Services, Puerto Rico Region, San Juan, PR by telephone on October 16, 1996. Firm-initiated recall complete. DISTRIBUTIONY: Puerto Rico. QUANTITY: One unit. REASON: Blood product, that had a positive antibody screening test, was distributed. ________ PRODUCT: Red Blood Cells Irradiated. Recall #B-950-1. CODE: Unit 7540598. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on February 17,1998. Firm-initiated recall complete. DISTRIBUTIONY: Kansas. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Roche Chemstrip 9 Urine Test Strips, Catalog No. 417109. Recall #Z-328-1. CODE: Lot No. 263053. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN. RECALLED BY: Manufacturer, by letter on February 12,2001. Firm-initiated recall ongoing. DISTRIBUTIONY: Nationwide. QUANTITY: 13,178 vials. REASON: One of the component pads for the leukocyte test area was missing, which will result in a false negative result for leukocytes. ________ PRODUCT: DePuy PS Reusable Tourniquet Cuffs, Bier’s Block: a) PS Reusable Tourniquet Cuff, 18 inch, Single Hose, Bier’s Block, Catalog No. 6671-50-000. Recall #Z-332-1. b) PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier’s Block, Catalog No. 6671-52-000. Recall #Z-333-1; c) PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier’s Block, Catalog No. 6671-52-000. Recall #Z-334-1; d) PS Reusable Tourniquet Cuff, 18 inch, Double Hose, Bier’s Block, Catalog No. 6672-50-000. Recall #Z-335-1. CODE: a) Lot No. U2EAG3000; b) Lot No. U1JAE3000; c) Lot No. U2PAB3000; d) Lot No. U2EAG3000. MANUFACTURER: DePuy Orthopaedics, Inc., Warsaw, IN. RECALLED BY: Manufacturer, by telephone and letter on November 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Arkansas, Tennessee, Indiana, Alaska, New York, Iowa, Florida, Texas, Washington, North Carolina. One account in Spain. QUANTITY: 16 REASON: Deflation of the tourniquet cuff as a result of the hose disconnecting from the port of the cuff. ________ PRODUCT: Dash Patient Monitors, Models 2000 and 3000 a) Dash Patient Monitor, Model No. 2000. Recall #Z-337-1; b) Dash Patient Monitor, Model No. 3000. Recall #Z-338-1. CODE: All units. MANUFACTURER: GE Medical Systems Information Technologies, Inc., Milwaukee, WI. RECALLED BY: Manufacturer, by letter on December 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, worldwide. QUANTITY: 8,702 devices. REASON: The monitor alarms fail to sound after 414 days of usage. ________ PRODUCT: Flowrider Micro Catheter: a) Model No. 105-5060(1.8F). Recall #Z-339-1; b) Model No. 105-5062 (FlowRider II). Recall #Z-340-1; c) Model No. 105-5063(1.5F). Recall #Z-341-1. CODE: Serial Numbers affected by the recall are: Model 105-5060 M980170 M980181 M980266 M980351 M980362A M980362B M980395 480134J 480334J 480334JA 490624J 500194J 500304J 500804J 510414J 510424J 510824J 510654J 520214J 520354J 480124J Model 105-5062 FlowRider II 520594J 520894J 530014J 530444J 530974J 530984J 540254J 550904J 560374J 560374J-A 570254J Model 105-5063 1.5F 511224J 520294J 530454J 540134J 540224J 540764J 540774J 550554J 550734J 550854J MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA. RECALLED BY: Manufacturer, by facsimile letter on August 20, 2000. Firm-initiated recall complete. DISTRIBUTION: States of CA & TX. Internationally to Australia, Denmark, Turkey, France, Italy, Switzerland, India, Japan, Korea, England, Germany, Spain, Brazil. QUANTITY: 1,111 units. REASON: The device fails to perform as designed. The device may leak therapeutic agents and contrast media into the peripheral and neuro vasculature due to failure of the catheter wall. ________ PRODUCT: Accu-Chek® Advantage® meters and Accu-Chek® Voicemate®. a) Accu-Chek Advantage I meter. Recall #Z-342-1; b) Accu-Chek Advantage II meter. Recall #Z-343-1; c) Voicemate System. Recall #Z-344-1. CODE: a) Model Nos. 768, 870, 800683, 800684; b) Model No. 213890; c) Model Nos. 2030802 and 3040208. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN. RECALLED BY: Manufacturer. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, worldwide. QUANTITY: 2 million. REASON: A software problem causes the memory to store erroneous values under specific circumstances. If the user performs a test when the meter’s internal clock registers 12:00 (midnight) - 12:10 am on the day the meter believes is Day 1 of a 7 day cycle, the test result can be incorrect. The same software problem also causes the Voicemate meters for the visually impaired to orally report erroneous values taken from the meter memory. ________ PRODUCT: Abbott Provider 5500 Infusion Pump. Recall # Z-383-1; Abbott Provider 6000 Infusion Pump. Recall # Z-384-1. CODE: All. MANUFACTURER: Abbott Laboratories, Inc., San Diego, CA. RECALLED BY: Manufacturer, by letter on October 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Australia, Belgium,Canada, England, France, Hong Kong, Indonesia,Ireland, Korea,Netherlands, Switzerland, Taiwan QUANTITY: 3,087. REASON: The product can overinfuse in the "bolus only" mode which does not result in a failure alarm. ________ PRODUCT: a) Customized Heart Lung Perfusion Packs, 44 catalog numbers: #020151120. Recall #Z-0409-1; #020163509. Recall #Z-0410-1; #020295603. Recall #Z-0411-1; #020298017. Recall #Z-0412-1; #020331604. Recall #Z-0413-1; #020385603. Recall #Z-0414-1; #020394603. Recall #Z-0415-1; #020410603. Recall #Z-0416-1; #020457603. Recall #Z-0417-1; #020469510. Recall #Z-0418-1; #020878601. Recall #Z-0419-1; #020907216. Recall #Z-0420-1; #024497019. Recall #Z-0421-1; #067100001. Recall #Z-0422-1; #067105001. Recall #Z-0423-1; #067115001. Recall #Z-0424-1; #067133001. Recall #Z-0425-1; #067138002. Recall #Z-0426-1; #078132012. Recall #Z-0427-1; #078149015. Recall #Z-0428-1; #078212007. Recall #Z-0429-1; #078238005. Recall #Z-0430-1; #078274007. Recall #Z-0431-1; #078303008. Recall #Z-0432-1; #078322005. Recall #Z-0433-1; #078351007. Recall #Z-0434-1; #078385005. Recall #Z-0435-1; #078429007. Recall #Z-0436-1; #078517002. Recall #Z-0437-1; #078595005. Recall #Z-0438-1; #078595006. Recall #Z-0439-1; #078634005. Recall #Z-0440-1; #078637004. Recall #Z-0441-1; #078656003. Recall #Z-0442-1; #078713002. Recall #Z-0443-1; #078722002. Recall #Z-0444-1; #078728002. Recall #Z-0445-1; #078729004. Recall #Z-0446-1; #078733001. Recall #Z-0447-1; #078739005. Recall #Z-0448-1; #078740002. Recall #Z-0449-1; #078766003. Recall #Z-0450-1; #078838003. Recall #Z-0451-1; #078876003. Recall #Z-0452-1; b) Sterile Sample Customized Heart Lung Perfusion Packs #020824601. Recall #Z-0453-1; #020848601. Recall #Z-0454-1; #020851601. Recall #Z-0455-1; #020883602. Recall #Z-0456-1; #067153001. Recall #Z-0457-1; #078424010. Recall #Z-0458-1; c) Bulk Sterile Purge Line #029177100. Recall #Z-0459-1; CODE: Customized Heart Lung Perfusion Packs, 44 catalog numbers: a) Lot #10F0323. Lot #06F0323, 08F0386, 10F0051, 11F0163 Lot #06F0347 Lot #07F0038, 10F0453 Lot #09F0212, 09F0251, 10F0328 Lot #10F0254 Lot #10F0341 Lot #10F0260 Lot #10F0116 Lot #10F0410 Lot #10F0392 Lot #06F0193, 08F0231, 10F0353 Lot #06F0189, 08F0036, 08F0375, 10F0428 Lot #10F0110 Lot #11F0104 (added on 1/10/01) Lot #10F0080 Lot #10F0194 Lot #10F0389 Lot #09F0266, 10F0362 Lot #11F0099 Lot #10F0024, 11F0024 Lot #11F0030 Lot #06F0089, 07F0185, 08F0258, 10F0013, 10F0369 Lot #07F0017, 08F0288, 09F0119 Lot #08F0256, 10F0290 Lot #07F0094, 08F0192, 09F0261, 10F0294 Lot #10F0102 Lot #06F0300, 07F0081, 08F0265, 10F0101 Lot #06F0168, 07F0100, 08F0194, 10F0011, 10F0384 Lot #06F0248, 08F0006, 09F0117 Lot #11F0098 (added on 1/10/01) Lot #09F0269, 10F0286, 11F0115 Lot #06F0005, 06F0379, 09F0195, 10F0460 Lot #07F0003, 09F0265, 10F0461 Lot #06F0255, 08F0346, 10F0464 Lot #06F0159, 08F0011, 08F0348, 10F0368 Lot #06F0151, 09F0118 Lot #08F0180, 10F0276 Lot #05F0004, 08F0082 Lot #11F0111 Lot #04F0186, 06F0165, 11F0214 Lot #08F0253, 10F0191 Lot #09F0002, 11F0003 Lot #11F0210 b) Lot #06F0862MP Lot #08F0827MP Lot #08F0832MP Lot #09F0850MP Lot #09F0832MP Lot #09F0852MP c) Lot #06F0600 MANUFACTURER: COBE Cardiovascular, INC., Arvada, CO. RECALLED BY: Manufacturer, by letter on November 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 3673. REASON: Plastic one-way valve located in the arterial filter purge line may break.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Total Ossicular Reconstruction Prostheses - Wiet Flex H/A Offset Head H/A, and Causse Flex H/A Notched H/A Offset: a) Weit Flex H/A Offset Head H/A, Catalog No. 0515. Recall #Z-316-1; b) Causse Flex H/A Notched H/A Offset, Catalog No. 0518. Recall #Z-317-1. CODE: a) Lot No. 20365700; b) Lot No. 20355500. MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL. RECALLED BY: Manufacturer, by letter on January 18, 2001. Firm-initiated recall ongoing. DISTRIBUTION: PA, VA, NY, IL and OH. QUANTITY: 44 REASON: The product labeling was switched. ________ PRODUCT: ALCYON Clinical Chemistry Analyzer. Recall #Z-325-1. ALCYON Direct HDL. Recall #Z-326-1. CODE: Model Nos. 300 and 300i. MANUFACTURER: Abbott Laboratories, Inc., Irving, TX. RECALLED BY: Manufacturer, by letter on November 13, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide and International. QUANTITY: 1,039 units. REASON: There is possible to obtain depressed or lower HDL Cholesterol results in some lipemic specimens when using the ALCYON Direct HDL method. ________ PRODUCT: i-STAT Creatinine Cartridge: i-STAT Catalog No. 320100; Recall #Z-329-1; Abbott laboratory List Nos. 06F10-01, 06F10-02. Recall #Z-330-1. CODE: Lot Nos. P00278, P00290, P00293, P00326, T00313, T00313A, K00311, K00315, K00315A, K00316, K00316A, K00320, K00320A, and K00322B. MANUFACTURER: i-Stat Corp. East Windsor, NJ. RECALLED BY: Manufacturer, by e-mail on January 10, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, worldwide. QUANTITY: 45,750. REASON: A change in the manufacturing process causes these cartridges to be incompatible with the analyzers (i-STAT Portable Clinical analyzer and the Hewlett Packard Blood Analysis Module). ________ PRODUCT: Hemoclip S15 Ligating Clip Appliers, Catalog No. 523701. Recall #Z-331-1. CODE: Lot No. 587161. MANUFACTURER: Weck Closure Systems, Research Triangle Park, NC. RECALLED BY: Manufacturer, by telephone and letter on August 21, 22, and 25, 2000. Firm-initiated recall complete. DISTRIBUTION: NY, RI, TX, and UT. One distributor in France. QUANTITY: 89. REASON: A pinhole in the sterile blister pack. ________ PRODUCT: Nitinol Laser Grasper Set, Catalog No. NLGS-030115-UDH. Recall #Z-336-1. CODE: All Lot Numbers. MANUFACTURER: Cook Urological, Inc., Spencer, IN. RECALLED BY: Manufacturer, by letter dated January 25, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, and Canada, Hong Kong, Ireland, Israel, Japan, Singapore, South Africa and Taiwan. QUANTITY: 225. REASON: The cannula may separate from the PINT shaft at the proximal end inside the handle causing the handle to malfunction. ________ PRODUCT: Sample Cups for use on Roche/Hitachi and Elecsys analyzers, Catalog 40904100. Recall #Z-345-1. CODE: Lot No. 714747. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN. RECALLED BY: Manufacturer, by letter on February 1, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, VA hospitals in IA, MN, WA, and OH. QUANTITY: 500,000 cups. REASON: Some sample cups in this lot are manufactured incorrectly in that the liquid reservoir space is decreased. The decrease space could result in probe crash, compromised dead volumes and the possibility of samples being read incorrectly without a warning being sent to the system.END OF ENFORCEMENT REPORT FOR APRIL 4, 2001. ####
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