November 7, 2001 01-44
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Bulk sun dried, salt treated tomatoes in 5 lb. clear vacuum packed plastic bags, 4 bags per white cardboard cartons, distributed by Woodland Foods, product of Turkey F-027-2, D'Allasandro Gourmet Ingredients Halves Sun Dried Tomatoes, Natural, item #T03 F-028-2, D'Allasandro Gourmet Ingredients Julienne Sun Dried Tomatoes, Natural, item #T12 Codes:Item numbers T03 and T12, lot numbers ending in 01-1285 REASON: Product contains the pesticide Bromopropylate. MANUFACTURER: Isik Organik Gida Tarim Izmir, TR RECALLED BY: Woodland Foods Gurnee, IL, by letter on 6/14/01 FIRM INITIATED RECALL: Complete DISTRIBUTION: OR, IN, CA, IL, NY and DC QUANTITY: 65 lbs. - halves, 3805 lbs. julienne _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-029-2, Norman's Nordic Kringla, Lemon Poppyseed, packaged in 7-oz. bags, 6 kringla per bag. The bags are packaged in a case labeled as Normans Kringla Assortment, which contains 2 bags of the lemon poppyseed, 14 bags of original, and 8 bags of almond kringla. The responsible firm on the case shows the product is manufactured by Field Foods, Inc., Story City, IA. Codes: The product does not bear a code or expiration date. REASON: The product contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. MANUFACTURER/RECALLING FIRM: Field Foods, Inc. Roland, IA RECALLED BY: Recalling firm via telephone on 9/19/01 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: Approx. 24-30 cs. of assorted Kringlas (ea. cs. contains 2 lemon poppyseed Kringlas).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-030-2, NutraBalance Thickened Dairy, 2% Milk Fortified with Vitamins A&D, Nectar-Like Product, packed in 8-oz and 1-liter size Tetra-brik carton/containers, 27/8-oz containers per case and 12/1-liter containers per case. Codes: 1 liter Tetra Brik - 12 ct case: SYSCO Item #4960746; Ross Item #55989 - Batch Numbers: 770236M00, 770236M10, 790386M10, 790386M20, and 790406M00. 8 fl. oz. Tetra Brik - 27 ct case: SYSCO Item #4960753; Ross Item #55993 - Batch Numbers: 770246M00, 770246M10, 770256M00, 770256M10, 770256M20, 790386M00, 790386M10, and 790396M00. REASON: Misbranded. The label states zero mg potassium per serving; the product actually contains 370mg potassium per serving. MANUFACTURER: Savannah Manufacturing/Abbott Hospital Products N. Chicago, IL RECALLED BY: Ross Products Division, Abbott Laboratories, Inc. Columbus, OH, by telephone, on 9/28/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 5,334 cases total (4,366 cases of 8oz; 968 cases of 1-liter)RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: a) D-010-2, Sodium Bicarbonate Injection, USP, 84 mg/mL, 50 mEq/50 mL, 50 mL single dose vial, NDC #63323-006-50, product code 0650; For IV Use Only, Preservative Free b) D-011-2, Multi Vitamin Concentrate, 5 mL single dose vial, NDC #63323- 042-05, product code 4205; For IV Infusion After Dilution c) D-012-2, Vinblastine Sulfate Injection, 1 mg/mL, 10 mL multiple dose vial, NDC #63323-278-10, product code 27810; For IV Use Only d) D-013-2, Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL in 2 mL single dose vial - NDC #63323-165-01, product code 16501 and 5 mL multiple dose vial - NDC #63323-165-05, product code 16505; For IM or IV Use e) D-014-2, Potassium Phosphates Injection, USP, Phosphorus 3 mM/mL and Potassium 4.4 mEq/mL, 50 mL single dose vial, NDC #63323-086-50, product code 8650; For IV Use Only After Dilution f) D-015-2, Potassium Acetate Injection, USP, 2 mEq/mL, 50 mL single dose vial, NDC #63323-076-50, product code 7650; For IV Use Only After Dilution g) D-016-2, Clindamycin Injection, USP, 150 mg/mL, 4 mL in 5 mL vial, product code C28204, DIN 021 39286 h) D-017-2, Sodium Chloride (Chlorure De Sodium) Injection, USP, 800 mmol/200 mL, 4 mmol/mL, 200 mL vial, DIN #02139510, product code C88B2; For intravenous infusion after diluation, Pharmacy Bulk Package, Not for Direct Infusion i) D-018-2, Bacteriostatic Water for Injection, USP, 10 mL multiple dose vial, NDC #63323-950-10, product code 95106; packaged with the Chorionic Gonadotropin for Injection and used to reconstitute the lyophilized powder j) D-019-2, Chorionic Gonadotropin for Injection, USP, 10,000 units/mL, 1 mL in 2 mL multiple dose vial (lyophilized), NDC #63323-025-10, product code 25021; For IM Use Only After Reconstitution Codes: a) Sodium Bicarbonate Injection, USP, lot 110660, exp. 01/03, lot 110670, exp. 01/03 b) Multi Vitamin Concentrate, lot 110664, exp. 01/03 c) Vinblastine Sulfate Injection, lot 110680, exp. 01/03 d) Dexamethasone Sodium Phosphate Injection, USP, lot 110739, exp. 02/03, lot 110760, exp. 02/03, lot 110767, exp. 02/03 e) Potassium Phosphates Injection, USP, lot 110754, exp. 08/04 f) Potassium Acetate Injection, USP, lot 110766, exp. 02/04 g) Clindamycin Injection, USP, lot 110652, exp. 01/03 h) Sodium Chloride Injection, USP, lot 110710, exp. 02/03 i) Bacteriostatic Water for Injection, USP, lot 110653, exp. 07/04 j) Chorionic Gonadotropin for Injection, USP, lot 110645, exp. 07/03 REASON: Lack of assurance of sterility MANUFACTURER/RECALLING FIRM: American Pharmaceutical Partners, Inc., Melrose Park, IL RECALLED BY: Recalling firm, by letters dated 9/28/01 and 10/5/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 504471 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-021-2, Zestril Tablets (lisinopril), 10 mg, Rx, once-daily tablets, 100 tablets/bottle, Lot R2817, Exp. 02-03, NDC 0310-0131-10. Manufactured by IPR Pharmaceuticals, Distributed by Zeneca Pharmaceuticals, Repackaged by Prestige Packaging. Codes: Lot R2817, Exp. 02-03 REASON: Mispackaging; Bottles labeled as 10 mg may contain 20 mg tablets MANUFACTURER: IPR Pharmaceuticals, Carolina, PR RECALLED BY: Prestige Packaging Inc. Farmington Hills, MI, by letters dated 10/2/01 and 10/4/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MI and OH QUANTITY: 953 bottles distributedRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: 1. D-008-2 Burn relief spray containing Benzocaine 5.0% and Benzalkonium chloride 0.14% packaged in 3-fl. oz. containers, OTC. The product is packaged under the following labels: a. York Burn Relief with Aloe Vera Antiseptic/Anesthetic, Manufactured by York Pharmaceuticals, Inc., Kansas City, KS b. Zee Burn Relief Spray with Aloe Vera, Antiseptic/ Anesthetic, Manufactured for Zee Medical, Inc., Irvine, CA c. Medi First Plus Pain Relieving Burn Spray with Aloe Vera, Antiseptic Anesthetic, Packaged for Medi First Plus, Skokie, IL d. Burn Relief with Aloe Vera Antiseptic, Manufactured for First Aid Direct, Sunrise, FL 2. D-009-2 Antiseptic Spray containing Lidocaine 2.5% and Benzalkonium chloride 0.14%, packaged in 3-fl. oz. containers, OTC. The product is packaged under the following labels: a. Zee First Aid Antiseptic Spray, Manufactured for Zee Medical, Inc., Irvine, CA b. Medi First Plus Pain Relieving Antiseptic Spray, Packaged for Medi First Plus, Skokie, IL c. First Aid Antiseptic, Manufactured for First Aid Direct, Sunrise, FL d. First Aid Only Antiseptic Spray, Distributed by First Aid Only, Inc., Vancouver, WA e. Respond First Aid Antiseptic, Distributed by Respond Industries, Inc., Denver, CO Codes: Burn Spray Lot # Exp. Date Label 0001123 Jan 02 Zee Medical 0008095 Aug 02 Zee Medical 0008096 Aug 02 Zee Medical 0009013 Sep 02 Zee Medical 0010004 Oct 02 First Aid Direct, Medi First, & Zee 0010005 Oct 02 First Aid Direct & Zee Medical 0011014 Nov 02 First Aid Direct & Zee Medical 0011037 Nov 02 York, First Aid Direct, Respond & Zee 0012017 Dec 02 Zee Medical 0101045 Jan 03 Zee Medical 0103017 Mar 03 York & Zee Medical 0103078 Mar 03 York & Zee Medical Antiseptic Spray Lot # Exp. Date Label 0001096 Jan 02 First Aid Only 0001133 Jan 02 Zee Medical 0002031 Feb 02 Zee Medical 0002046 Feb 02 Zee Medical 0002054 Feb 02 Zee Medical 0002057 Feb 02 Zee Medical 0002089 Feb 02 Zee Medical 0002090 Feb 02 First Aid Direct, First Aid Only & Zee 0003001 Mar 02 First Aid Only 0003010 Mar 02 First Aid Only 0003065 Mar 02 First Aid Only and Respond 0003092 Mar 02 First Aid Direct, First Aid Only & Medi First 0004041 Apr 02 First Aid Only & Zee Medical 0005022 May 02 Zee Medical 0005023 May 02 Zee Medical 0005024 May 02 First Aid Only & Zee Medical 0005100 May 02 First Aid Only 0005111 May 02 First Aid Only 0006003 Jun 02 First Aid Only & Zee Medical 0006007 Jun 02 Zee Medical 0103079 Mar 03 Zee Medical 0104038 Mar 03 Zee Medical 0105006 Mar 03 Zee Medical 0105023 Mar 03 Zee Medical REASON: Burn Relief Spray active ingredient Benozocaine is super-potent -- Antiseptic Spray active ingredient Lidocaine is sub-potent MANUFACTURER/RECALLING FIRM: York Pharmaceuticals, Inc. Kansas City, KS RECALLED BY: Recalling firm, via letter dated 8/27/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, CA, FL, CO, IL, TN, GA, and FL QUANTITY: Burn spray - 105,996 bottles; antiseptic spray - 247,596 btls _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-020-2, Colocort, Hydrocortisone Enema,USP,(Retention)100 mg/60 ml, For Rectal Use Only, Rx only, disposable, single-dose bottle, NDC Numbers 0574-2020-01 (one single 60 ml bottle in a box) and 0574-2020-07 (box of seven 60 ml bottles of the product) Codes: Lot numbers 9M6024, 9M6049, 9M6051, 0C6226, 0C6230, 0E6338, OE6345, 0E6360, 0E6366, 0E6372, 0H6558, 421557, 431587, 441605, 441625, 481764, and 481782 REASON: Impurity specification failure at stability testing (18 months) MANUFACTURER/RECALLING FIRM: Paddock Laboratories, Inc. Minneapolis, MN RECALLED BY: Recalling firm, by letter, dated 10/04/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 230,000 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-022-1, Bronchial Mist, Epinephrine Inhalation Aerosole USP,1/2 Fluid ounce (15 mL),5.5 mg/mL Epinephrine, plastic coated glass vials packaged 1 per carton, 24/case. Packaged with actuator. Codes: lot RD 1406 Exp 5/03 REASON: Dosage Uniformity Failure MANUFACTURER/RECALLING FIRM: Armstrong Laboratories West Roxbury, MA RECALLED BY: Alpharma USPD Baltimore, MD, by letter on 9/20/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: TN, IN, CT, KY, and RI QUANTITY: 4608 unit doses _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-023-2, Hyoscyamine Sulfate, USP, Extended Release Capsules, 0.375 mg, 100 capsule bottles, Rx only, NDC 51285-938-02. Codes: Lots 0024E, 0043E. REASON: Sub-potency (9 month stability station) MANUFACTURER/RECALLING FIRM: Carlsbad Technology, Inc., Carlsbad, CA RECALLED BY: Recalling firm, via telephone, fax and letter on 9/10/2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 800,000 capsulesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0001-2, Corneas, Tissue Identification Numbers 01-0789,01-0790 REASON: Corneas, collected from a donor who tested repeatedly reactive for the HIV p24 antigen, with no HIV 1/2 DNA detected by PCR, were distributed. MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Central Texas, Austin, TX RECALLED BY: The recalling firm by letters dated August 31, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas and Mexico QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0002-2, Source Plasma, Units 27868874, 29774487, 29777525, 28280514, 28283027, 28285854 REASON: Blood products, collected from a donor with a history of intravenous drug use, were distributed. MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center, Dallas, TX RECALLED BY: The recalling firm by facsimile on September 14, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0010-2, Source Plasma, Unit Q5E446 REASON: Blood product that tested negative for HBsAg, but was not quarantined after the donor subsequently tested RR for HBsAg, was distributed. MANUFACTURER/RECALLING FIRM: Alabama Plasma, Inc., Birmingham, AL RECALLED BY: The recalling firm by telephone on November 1, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0013-2, Platelets, Leukocytes Reduced, Unit 7475165 REASON: Blood product, which was labeled as leukoreduced, but failed the quality control specification for white blood cell count, was distributed. MANUFACTURER: New York Blood Center, Melville, NY RECALLED BY: New York Blood Center (Center West), New York, NY, by letter dated June 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: New York QUANTITY: 1 unit _________________________________ RECALL NUMBER, PRODUCT AND CODE: B-0058-2, Source Plasma for Manufacturing Use Only, Unit 00LWIB4967 REASON: Blood product, collected from a donor who engaged in multiple high-risk behaviors, was distributed. MANUFACTURER: Community Bio-Resources, Inc., Onalaska, WI RECALLED BY: Community Bio-Resources, Inc., Hoover, Al, by fax dated June 6, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 1 unit ______________________________ RECALL NUMBER,PRODUCT AND CODE: B-0059-2, Source Plasma for Manufacturing Use Only, Units 00LWIB5087, 00LWIB5564 REASON: Blood products, collected from a donor who engaged in high-risk behavior, were distributed. MANUFACTURER: Community Bio-Resources, Inc., Onalaska, WI RECALLED BY: Community Bio-Resources, Inc., Hoover, Al, by fax dated June 6, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0062-2, Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton; 24 cartons distributed Lot Number P000890, Expiration date 12/02 REASON: Counterfeit Neupogen was distributed. RECALLING FIRM: Albers Medical, Inc., Kansas City, MO RECALLED BY: The recalling firm, by telephone on May 1, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: TN and NJ QUANTITY: 240 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0063-2, Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton; 18 cartons distributed, Lot Number P000890, Expiration Date 12/02 REASON: Counterfeit Neupogen was distributed. RECALLING FIRM: H.D. Smith Drug Company, Carlstadt, NJ RECALLED BY: The recalling firm, by letters on June 1, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY and NJ QUANTITY: 180 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0064-2, Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton, 117 vials Lot Number P000890, Expiration Date 12/02 Lot Number P000948, Expiration Date 03/03 Lot Number P000992, Expiration Date 06/03 REASON: Counterfeit Neupogen was distributed. RECALLING FIRM: Drug Max, Pittsburgh, PA RECALLED BY: The recalling firm, by letter on May 29, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, DC, FL, GA, MI, NJ, NY PA, TX and WA QUANTITY: 117 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0065-2, Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton, 287 cartons, Lot Number P000890, Expiration Date 12/02 REASON: Counterfeit Neupogen was distributed. RECALLING FIRM: TW Medical Veterinary Supply, Leander, TX RECALLED BY: The recalling firm, by telephone on May 7, 2001, and by letters on June 1, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MO, PA and FL QUANTITY: 2,870 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0066-2, Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton, 17 boxes distributed Lot Number P000890, Expiration Date 12/02 Lot Number P000992, Expiration Date 06/03 REASON: Counterfeit Neupogen was distributed. RECALLING FIRM: Top Source, Bartlett, TN RECALLED BY: The recalling firm by telephone on May 18, 2001 and telephone and letter on May 22, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, NM, VA, CA and NJ QUANTITY: 17 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0067-2, Platelets, Units 30 34322, 30 34323 REASON: Blood products, which had unacceptable platelet counts, were distributed. MANUFACTURER/RECALLING FIRM: The Community Blood Center, Inc., Appleton, WI RECALLED BY: The recalling firm by letters dated May 16, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: WI QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0069-2, Red Blood Cells, Unit C70268 B-0070-2, Recovered Plasma, Unit C70268 REASON: Blood products, collected from a donor who had surgery within 48 hours of donation, were distributed. MANUFACTURER/RECALLING FIRM: Virginia Blood Services, Richmond, VA RECALLED BY: The recalling firm by letter dated June 11, 2001 or by facsimile on June 6, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: VA and Switzerland QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0071-2, Albuminar-5 Albumin (Human) U.S.P. 5%; 250 mL vials, containing 12.5 grams and 25.0 grams of albumin in normal saline, 210,270 vials distributed Lot numbers: W34710, W35010, W35110, W35210, W41311, W41411, W41411B, W41511, W41611, W41711, W41811, W41911, W42111, W42211, W42311, W42411, W42511, W42611, W42712, W42812, W42912, W43012, W43112, W43312, W43412, W43512, W43612, W43712, W43912, W44012, W44212, W44312, W44412, W44612, W44712, W44812, W44912, W45012, W45112, W45212, W45312, W45412, W45512, W45712, W45812, W45912, W46112, W46412, X700601, X700701, X701001, X701101, X702602, X702702, X704602, X704702, X704902, X705002, X705202, X705302, X705402, X707203, X707303, X707503, X707703, X707803, X708604 Albuminar-5 Albumin (Human) U.S.P. 5%; 500 mL vials containing 12.5 grams and 25.0 grams of albumin in normal saline, 100,699 vials distributed Lot numbers W34209, W34309, W34409, W34509, W35310, W35410, W35510, W35610, W35710, W35810, W35910, W36010, W36110, W36210, W36310, W36410, W36510, W36610, W36710, W36810, W37010, W37110, W37210, W37310, W37410, W37510, W37610, W37710, W37810, W37910, W38010, W38110, W38210, W38310, W38410, W38510, W38610, W38711, W38811, W38911, W39011, W39111, W39211, W39311, W39411, W39711, W39811, W39911, W40011, W40111, W40211, W40311, W40611, W40811, W41011, X700001, X700201, X700401, X701501, X701601, X701901, X708203, X708403 REASON: Sterility of the products may have been compromised due to the potential for holes in the stopper septum. MANUFACTURER: Aventis Behring L.L.C., Bradley, IL RECALLED BY: Aventis Behring L.L.C., King of Prussia, PA, by facsimile letters dated July 20, 2001, which were followed up with telephone calls. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 210,270 vials 100,699 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0072-2, Platelets, Pheresis (34 units), unit numbers 09FP11944, 09FP12385, 09FP12782, 09FP13357, 09FP13811, 09FP13964, 09FP14398, 09FP14862, 09FP15311, 09FP16156, 09FP16478, 09FP17790, 09FP18451, 09FP19246, 09P58687-1, 09P58687-2, 09P59321, 09P61935, 09P63484, 09P64721-1, 09P64721-2, 09P65136-1, 09P65136-2, 09P67413-1, 09P67413-2, 09P69358-1, 09P69358-2, 09P69772-2, 09P70157-1, 09P70157-2, 09P70651-1, 09P70651-2, 09P70704-1, and 09P70704-2 REASON: Blood products, labeled with incorrect human leukocyte antigen (HLA) type, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Omaha, NE RECALLED BY: The recalling firm, by letters dated February 19 and 24, 1999, and March 26, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, AR, OR, NE, IA QUANTITY: 34 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0073-2, Red Blood Cells, Leukocytes Reduced, Unit number 0736672 REASON: Blood product, collected from a donor that tested positive for the Fya blood group antigen, but was labeled Fya negative, was distributed. MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of Minnesota, Minneapolis, MN RECALLED BY: The recalling firm by telephone on June 6, 2000, and by letter dated June 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0074-2, Platelets, Pheresis, Leukocytes Reduced, unit numbers 0796321 and 0805277 REASON: Blood products with an increased platelet count that were not tested for pH as required were distributed. MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of Minnesota, Minneapolis, MN RECALLED BY: The recalling firm by letter dated January 30, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: MN QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0075-2, Red Blood Cells, Leukocytes Reduced, unit number 10706-7964 B-0076-2, Recovered Plasma, unit number 10706-7964 REASON: Blood products, collected from a donor whose health history screening was inadequately performed, were distributed. MANUFACTURER: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: Manufacturer by telephone and letter on or about April 18, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ and VA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0079-2, Red Blood Cells, Leukocytes Reduced, Unit number 50LG41701 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Toledo, OH RECALLED BY: The recalling firm by letter dated April 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0080-2, Platelets, Pheresis, unit number 7445418 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm by letter dated June 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0081-2, Red Blood Cells, Leukocytes Reduced, unit number 12M05709 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Charlotte, NC RECALLED BY: The recalling by telephone on July 18, 2001, and by letter dated August 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 1 unit ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0082-2, Red Blood Cells, Leukocytes Reduced, unit number 12L58954 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Charlotte, NC RECALLED BY: The recalling firm by telephone on July 13, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 1 unit ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-100-2, Red Blood Cells (8 units), unit numbers 21GS06356, 21Y58308, 21Y56749, 21Y55436, 21Y54094, 21Y52852, 21Y48696, and 21Y47492 B-101-2, Red Blood Cells, Leukocytes Reduced (7 units), unit numbers 21Y63240, 21Y62050, 21GS09211, 21KQ04129, 21KQ02382, 21Y59615, and 21Y51171 B-102-2, Cryoprecipitated AHF (13 units), unit numbers 21Y63240, 21Y62050, 21GS09211, 21KQ04129, 21GS06356, 21Y59615, 21Y58308, 21Y56749, 21Y55436, 21Y54094, 21Y52852, 21Y48696, and 21Y47492 B-103-2, Plasma (1 unit), unit number 21Y54094 REASON: Blood products, collected from an ineligible donor due to a history of medication with the drug Acyclovir (Zovirax), were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Salem, OR RECALLED BY: The American National Red Cross, Portland, OR, by telephone on February 16, 2001, and by letters dated February 21, 2001, and March 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ, CA, NJ, OR, TX, UT and WA QUANTITY: 29 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0225-2, Red Blood Cells, Leukocytes Reduced (1 unit), unit number 42FX94172 B-0226-2, Platelets, Leukocytes Reduced (2 units), unit numbers 42FX94172 and 42S57347 B-0227-2, Fresh Frozen Plasma (1 unit), unit number 42FX94172 REASON: Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Cleveland, OH RECALLED BY: The recalling firm by telephone on June 18, 2001, and by letter dated June 25, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 4 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0228-2, Red Blood Cells, Leukocytes Reduced (1 unit), unit number GK54195 B-0229-2, Recovered Plasma (1 unit), unit number GK54195 REASON: Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed. MANUFACTURER/RECALLING FIRM: Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA RECALLED BY: The recalling by letter dated April 24, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0230-2, Red Blood Cells (1 unit), unit number GL62814 B-231-2, Recovered Plasma (1 unit), unit number GL62814 REASON: Blood products, collected from an ineligible donor due to a history of intravenous (IV) drug use, were distributed. MANUFACTURER/RECALLING FIRM: Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA RECALLED BY: The recalling firm by letter dated April 24, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0241-2, Red Blood Cells, Leukocytes Reduced (1 unit), unit number FK32661 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services, Inc., Providence, RI RECALLED BY: The recalling firm by telephone on July 2, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: RI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0242-2, Red Blood Cells, Leukocytes, Reduced (2 units), Unit numbers 10627-0013 and 10633-3833 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: The recalling firm by letter on February 20, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0243-2, Red Blood Cells (1 unit), Unit number 10601-4607 B-0244-2, Red Blood Cells, Leukocytes, Reduced (2 units), Unit numbers 10626-7938 and 10630-7134 B-0245-2, Platelets (1 unit), unit number 10601-4607 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: By letters on December 22, 2000, and February 9, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0246-2, Red Blood Cells, Leukocytes Reduced (1 unit), unit number 10624-8100 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: By letter on August 23, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0077-2, Red Blood Cells, Leukocytes Reduced, unit numbers 4590376, 4716138, 6538799, and 6805488 REASON: Blood products were distributed with an elevated white blood cell count. MANUFACTURER/RECALLING FIRM: Central Indiana Regional Blood Center, Indianapolis, IN RECALLED BY: By telephone and by letter on August 22, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY: 4 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0078-2, Red Blood Cells, Leukocytes Reduced, Unit number 0788895 REASON: Blood product, that was incorrectly leukoreduced by filtration twice, was distributed. MANUFACTURER/RECALLING FIRM: Memorial Blood Centers of Minnesota, Minneapolis, MN RECALLED BY: By letter dated March 9, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-0247-2, Platelets, Pheresis (4 units), Unit numbers 04W757514, 04W757575, 04W757599, and 04W757587 REASON: Unlicensed blood products were distributed interstate. MANUFACTURER/RECALLING FIRM: Civitan Regional Blood Center, Inc., Gainesville, FL RECALLED BY: By letter dated October 31, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: AL QUANTITY: 4 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0214-2, Physiometrix PSARRAY EEG ELECTRODE Part Number: 4300-40 Lot Numbers: 010302A, 010303A, 010305A, 010308A, 010310A, 010314A, 010316A REASON: Stud in the electrode separates from the substrate and remains in the lead wire MANUFACTURER: Conmed Corp., Utica, NY RECALLED BY: Physiometrix, Inc., North Billerica, MA, by letter on 3/22/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IL, Sweden and, UK QUANTITY: 132 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0215-2, Itrel 3 Implantable Pulse Generator (Neurostimulator), Model 7425 Codes: Serial Numbers NAT118756H, NAT118757H, NAT118758H, NAT118759H, NAT118760H, NAT118761H, NAT118762H, NAT118763H, NAT118768H, NAT118769H, NAT118770H, NAT118771H, NAT118776H, NAT118777H, NAT118778H, NAT118779H, NAT118788H, NAT118789H, NAT118790H, NAT118791H, NAT118792H, NAT118793H, NAT118794H, NAT118795H, NAT118828H, NAT118829H, NAT118836H, NAT118838H, NAT118839H, NAT122388H, NAT122389H, NAT122390H, NAT122391H, NAT122392H, NAT122393H, NAT122394H, NAT122395H, NAT122410H, NAT122411H, NAT122412H, NAT122413H, NAT122414H, NAT122415H, NAT122432H, NAT122433H, NAT122435H, and NAT122439H REASON: Shocks to the patient at the implant site can occur due to missing insulation for the battery. MANUFACTURER: Medtronic Med Rel, Inc., Humacao, RQ RECALLED BY: Medtronic, Inc., Minneapolis, MN by letter dated 7/09/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 47 units (28 implanted) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia, Japan, Canada and Europe QUANTITY: 699 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0217-2, Roche Modular Analytics immunoassay based clinical analyzer, model E170, catalog number 7656961. REASON: May give incorrect thyroid test results MANUFACTURER: Hitachi Ltd. Japan RECALLED BY: Roche Diagnostics Corp., Indianapolis, IN FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IL, IN, MD, NY, NC, PA and WA QUANTITY: 7 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0218-2, DCA2000 Hemoglobin A1c Normal and Abnormal Control kit, catalog number 5068, Lot 0009 REASON: Defective Vials MANUFACTURER/RECALLING FIRM: Canterbury Scientific Ltd. Christchurch 1, New Zealand, RECALLED BY: Bayer Corp., Elkhart, IN, by fax and telephone on September 24, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Worldwide QUANTITY: 1902 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0219-2 - V40 Zirconia Femoral Heads, Model Nos. h 6364-4-028, h 6364-4- 032, h 6364-4-122, h 6364-4-126, h 6364-4-128, h 6364-4-132, h 6364-4- 222, h 6364-4-226, h 6364-4-228, h 6364-4-232; Z-0220-2 - Osteonics µ Zirconia C-Taper Femoral Bearing Head, Model Nos. h 16-2600, h 16-2605, h 16-2800, h 16-2805, h 16-3200, h 16-3205, h 16- 3299; Z-0221-2 - Exeter Ceramic Femoral Head, Model Nos.4658-2-801, 4658-2-802, 4658-3-201, 4658-3-202, 4658-3-203 REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads MANUFACTURER/RECALLING FIRM: Howmedica Osteonics Corp., Allendale, NJ RECALLED BY: Recalling firm by letter on 8/16/01, 8/22/01 and 8/23/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Model 6364: 3364, Model 16: 8585, and Model 4658: 352 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0222-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163110; Z-0223-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163111; Z-0224-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163130; Z-0225-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163131; Z-0226-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163132; Z-0227-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163113; REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: Biomet, Inc., Warsaw, IN RECALLED BY: Recalling firm by letter on 8/10/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & worldwide QUANTITY: 4,200 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0228-2, Zirconia Femoral Head Prosthesis, Catalog No. CFHS-028; Z-0229-2, Zirconia Femoral Head Prosthesis, Catalog No. CFHM-028; Z-0230-2, Zirconia Femoral Head Prosthesis, Catalog No. CFHL-028. REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads MANUFACTURER/RECALLING FIRM: Osteoimplant Technology (OTI), Inc., Hunt Valley, MD RECALLED BY: By recalling firm by phone on/about 8/9/01 and then by letter. FIRM INITIATED RECALL: Completed DISTRIBUTION: OK, IL & Spain QUANTITY: 37 units. ______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0231-2, Modular Zirconia Femoral Head, Catalog No. 322899; Z-0232-2, Modular Zirconia Femoral Head, Catalog No. 322800; Z-0233-2, Modular Zirconia Femoral Head, Catalog No. 322835; Z-0234-2, Modular Zirconia Femoral Head, Catalog No. 322807; REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: Apex Surgical, LLC, Lakeville, MA RECALLED BY: Recalling firm by letter on 8/15/01 FIRM INITIATED RECALL: Completed DISTRIBUTION: FL, NV, OK, SC, TN, TX QUANTITY: 55 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0235-2, Zirconia Ceramic Articul/eze Femoral Ball, Catalog Nos. 1365- 41-00, 1365-42-000, 1365-43-000, 1365-44,000, 1365-45-000, 1365-46-000, 1365-47-000, 1365-48-000; Z-0236-2, Zirconia Ceramic SROM Taper Femoral Head, Catalog No. 56-0028, 56-00298; Z-0237-2, Zirconia Ceramic Elite Taper Femoral Head, Catalog No. 9621-25- 000, 9621-26-000, 9621-27-000, 9621-30-000, 9621-31-000, 9621-16-000, 9621-17-000, 9621-18-000, 9621-19-000, 9621-20-000, 9621-21-000, 9621-22- 000, 9621-23-000, 9621-24-000; Z-0238-2, Zirconia Ceramic PFC Head, Catalog No. 85-3878, 85-3879, 85- 3880 REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: DePuy Orthopaedics, Inc., Warsaw, IN IMPORTER: Apex Surgical, LLC, Lakeville, MA RECALLED BY: Recall firm by letter to hospitals on August 13, 2001 asking them to return all of these devices in their possession. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: United States, Brazil, Canada and England QUANTITY: Over 20,000 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0239-2, Versys Hip System, Catalog Nos. 00-8118-022-02, 00-8118-028-01, 00-8118-028-02, 00-8118-028-03, 00-8118-032-02 and 00-8118-032-03; Z-0240-2, Zirconia Ceramic Femoral Head, Catalog Nos. 00-9030-028-00, 00- 9030-028-35, 00-9030-029-00, and 00-9030-029-35 REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: Zimmer, Inc., Warsaw, IN RECALLED BY: Recalling firm by letter on 8/16/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & International QUANTITY: 10,328 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0241-2, Zirconia Taper Femoral Head, Catalog No. 71320828; REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: Smith & Nephew, Inc., Memphis, TN RECALLED BY: Recalling firm by letter on 3/15/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Canada, & Greece QUANTITY: 49 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0242-2, Zirconia 12/14 Taper Femoral Head, 26mm, +0, Part No. 71320026, Lot Nos. 90611570, 00810016, 00810019, 01203382, 01203383; Z-0243-2, Zirconia 12/14 Taper Femoral Head, 26mm, +4, Part No. 71320426, Lot Nos. 00810020, 00810021, 01203384, 01203385; Z-0244-2, Zirconia 12/14 Taper Femoral Head, 26mm, +8, Part No. 71320826, Lot Nos. 90611571, 00810022, 00810023, 01203380, 01203381; Z-0245-2, Zirconia 12/14 Taper Femoral Head, 28mm, +0, Part No. 71320028, Lot Nos. 90107821, 90107822, 90107823, 90108442, 90108443, 90202378, 90202379, 90300445, 90300447, 90611572, 90306983, 90306984, 90306985, 90306997, 90306986, 90306987, 90306988, 90411386, 90411387, 90502073, 90502079, 90502080, 90502081, 90502082, 90502083, 90411388, 90411389, 90700276, 90700278, 90700279, 90700280, 90700281, 90700282, 90802697, 90802698, 90802699, 90802700, 90901889, 90901892, 90901893, 90901895, 90901897, 90901899, 90901900, 90901901, 90901902, 91005226, 91005227, 91005228, 91005229, 91005230, 91005231, 91005232, 91103444, 91103445, 91103446, 91103447, 91103448, 91103449, 91103450, 91204696, 91204697, 91204698, 91204699, 91204700, 91204701, 01204700, 00105762, 00105757, 00105759, 00105760, 00105803, 00105805, 00105806, 00105807, 00207310, 00207311, 00207312, 00207313, 00211929, 00211930, 00211931, 00211932, 00311848, 00311849, 00311850, 00311851, 00311852, 00311853, 00311854, 00511770, 00511772, 00603275, 00603276, 00603277, 00603279, 00603280, 00603281, 00603283, 00603285, 00603287, 00610965, 00610966, 00701793, 00701795, 00701796, 00701797, 00701798, 00706338, 00706339, 00901714, 00901715, 00901716, 00901717, 00901718, 00901720, 00901721, 00910581, 00910582, 00910583, 00910584, 00910617, 00910587, 01001665, 01001666, 01001667, 01104354, 01104355, 01104356, 01104357, 01104358, 01104362, 01012015, 01012016, 01012017, 01012018, 01012019, 01111813, 01111814, 01111815, 01111816, 01AM03161, 01AM03162, 01BM09428, 01BM09429, 01BM09430, 01BM09431 01BM09432, 01BM09434, 01BM09435, 01BM09436, 01BM12590, 01BM12591, 01CM08887, 01CM08889, 01CM08891, 01DM07940, 01DM07940A, 01DM07941, 01DM07942, 01DM07943, 01DM07944, 01DM07945, 01DM07946, 01DM07947, 01DM07948, 01EM01314, 01EM01315, 01EM01316, 01EM01317, 01EM01318, 01EM01319, 01EM01320, 01EM01321, 01EM01322, 01EM1322A, 1EM01323, 01EM01324, 01EM01325, 01FM05743, 01FM05744, 01FM05745, 01FM05746, 01FM05747, 01FM05748, 01FM05749, 01FM05750, 01FM05751, 01FM05752, 01FM05753, 01FM05754, 01FM05755, 01FM05756, 01FM05757, 01FM11567, 01FM11568, 01FM11569, 01FM11570, 01FM11571, 01FM11572, 01FM11573, 01FM11574, 01FM11575, 01FM11576, 01FM11578, 01FM11579, 01FM11580; Z-0246-2, Zirconia 12/14 Taper Femoral Head, 28mm, +4, Part No. 71320428, Lot Nos. 90107826, 90209515, 90209516, 90209517, 90209518, 90300451, 90300452, 90300449, 90506988, 90306989, 90306990, 90306991, 90306992, 90306993, 90502084, 90502085, 90502086, 90502074, 90502075, 90704484, 90602245, 90602246, 90602247, 90601125, 90601126, 90704485, 90704486, 90704487, 90704489, 90704490, 90704491, 90805027, 90805028, 90805030, 90805032, 90902941, 90902942, 90902943, 90902944, 90902945, 90902946, 90902947, 91002327, 91002328, 91002329, 91002330, 91002331, 91002332, 91002333, 91002334, 91202989, 91202990, 91110490, 91110491, 91110492, 91110493, 00104731, 00104732, 00104733, 00104734, 00104735, 00104736, 00104737, 00104738, 00104739, 00104740, 00207979, 00207980, 00207981, 00207982, 00207983, 00311855, 00311856, 00311857, 00311858, 00311859, 00311860, 00311861, 00607784, 00607785, 00607786, 00607787, 00610967, 00610968, 00610970, 00607788, 00901725, 00901726, 00901727, 00901743, 00701799, 00701800, 00701801, 00701802, 00701803, 00712034, 00712035, 00910592, 00910593, 01001668, 01001669, 01001670, 01001671, 01111817, 01111818, 01111819, 01111820, 01AM09107, 01AM09108, 01AM09109, 01AM09110, 01AM09111, 01AM09112, 01DM04535, 01CM01170, 01CM01171, 01CM01172, 01CM01173, 01BM12595, 01CM08894, 01CM08895, 01DM04536, 01DM13966, 01DM13967, 01DM13968, 01DM13969, 01DM13970, 01EM09820, 01EM09821, 01EM09822, 01EM09823, 01EM09825, 01EM09824, 01EM12680, 01EM12681, 01EM12682, 01EM12683, 01FM09026, 01FM09027, 01FM09028, 01FM09029, 01FM06259, 01FM06260, 01FM06261, 01FM06262, 01FM06263, 01FM06264, 01FM09030, 01GM06910, 01GM06912, 01GM06913, 01GM06915, 01GM06917, 01GM06918, 01GM06919, 01FM02976, 01FM03087; Z-0247-2, Zirconia 12/14 Taper Femoral Head, 28mm, +8, Part No. 1320828, Lot Nos. 80801579, 80800947, 80800948, 80801580, 90106724, 90106725, 90205143, 90205144, 90205145, 90205146, 90611573, 90307988, 90307989, 90307990, 90403953, 90403955, 90402819, 90402820, 90403958, 90502076, 90502077, 90502072, 90502078, 90601127, 90601128, 90601129, 90610106, 90610107, 90704492, 90704493, 90802694, 90802695, 90805041, 90805042, 90900206, 90900207, 91002326, 91006420, 91006421, 91006422, 91006423, 91006424, 91103451, 91204695, 00105584, 00105585, 00106970, 00106971, 00106972, 00106973, 00106974, 00106975, 00106976, 00106977, 00401125, 00401126, 00403537, 00403539, 00403540, 00407473, 00407476, 00407477, 00407478, 00701804, 00701805, 00810024, 00810025, 01200544, 01200545, 01200546, 01200547, 00810027, 00810028, 01203386, 01203387, 01203391, 01203392, 01CM08905, 01CM08906, 01CM04105, 01CM04106, 01CM08908, 01DM13971, 01DM13973, 01EM09826, 01EM09828, 01EM09829, 01EM09830, 01FM06266, 01FM06267, 01FM06268, 01FM06269, 01FM06270, 01FM06280, 01FM06282, 1FM06271, 01FM06272, 01FM09031, 01FM09032, 01FM09033, 01FM09034, 01FM09035. Z-0248-2, Zirconia 12/14 Taper Femoral Head, 32mm, +0, Part No. 71927729, Lot Nos. 01FM03862, 01AM14139, 01EM07106; Z-0249-2, Zirconia 12/14 Taper Femoral Head, 32mm, +4, Part No. 71927734, Lot Nos. 01FM14438, 01AM14153, 01FM03863; Z-0250-2, Zirconia 12/14 Taper Femoral Head, 32mm, +8, Part No. 71927735, Lot No. 01AM14150; Z-0251-2, Zirconia 14/16 Taper Femoral Head, 32mm, +0, Part No. 427815, Lot Nos. 00105698, 00105699, 00105700, 00105701; Z-0252-2, Zirconia 14/16 Taper Femoral Head, 32mm, +4, Part No. 427816, Lot Nos. 00105702, 00105703, 00105704; Z-0253-2, Zirconia 14/16 Taper Femoral Head, 32mm, +8, Part No. 427817, Lot No. 00105705. REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads. MANUFACTURER/RECALLING FIRM: Smith & Nephew, Inc., Memphis, TN RECALLED BY: Recalling firm by letter on 8/10/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & International QUANTITY: 8,040 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0254-2 A)Homedics brand Model PowerDent battery operated toothbrushes; all lots. The toothbrushes are sold as in packages of 1 as Model HD-30, packages of two as Model HD-30DP, and packages of 12 as Model HD-30-12PK. Z-0255-2 B)Homedics brand Model PowerDent Jr. battery operated toothbrush; all lots. The toothbrushes are sold as in packages of 1 as Model HD-20, packages of two as Model HD-20DP, and packages of 12 as Model HD-20-12PK. REASON: Defective seal allows water into handle MANUFACTURER: Teamedics Shenzhen, China, RECALLED BY: Homedics, Inc., Commerce Township, MI, by letter dated September 26, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 935,000 toothbrushes _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0256-2, CEDIA Phenobarbital II Reagent, Lot No. 28105900, Catalog No. 1775936 REASON: The kit’s bottles 1 and 2 were mislabeled. MANUFACTURER: Microgenics, Fremont, CA RECALLED BY: Roche Diagnostics Corporation, Indianapolis, IN, by product removal notification dated 10/08/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: United States, Australia, Canada, New Zealand QUANTITY: 476END OF ENFORCEMENT REPORT FOR NOVEMBER 7, 2001.
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