November 22, 2000 00-47RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Eagle Spice & Extract Co. brand Banana Flavor, in 1-quart and 1-gallon rigid plastic containers. Recall #F-042-1. CODE Quart lot numbers: BF0200 and BF0210; 1-gallon container lot #BF0950. MANUFACTURER Eagle Spice & Extract Company, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter dated April 20, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 9 cases (12 1-quart containers per case) and 5 cases 4 1-gallon containers per case) were distributed. REASON Banana flavor contains undeclared FD&C Yellow No. 5. ________ PRODUCT Fresh Express brand Iceberg Lover's Iceberg with Real Bacon Crumbles, in 12-ounce plastic bags. Recall #F-043-1. CODE UPC #7129-10803, Product Codes: 49476, 49487, 49529, 49498. MANUFACTURER Fresh Express-West, Salinas, California. RECALLED BY Fresh Express, Salinas, California, by letter on Monday August 28, 2000, and by press release. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 56,550 cartons (552,786 bags) were distributed. REASON Product was contaminated with plastic pieces. ________ PRODUCT Here's Howe Trail Mix, in 4-ounce plastic bags. Recall #F-044-1. CODE Lot Numbers: 27, 28, 29, 30, and 31 (indicate weeks of manufacturing). MANUFACTURER George J. Howe Company, Grove City, Pennsylvania. RECALLED BY Manufacturer, by visit beginning July 10, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Ohio. QUANTITY 49.5 cases (12 bags per case) were distributed. REASON Trail mix contained undeclared FD&C Yellow No. 6. ________ PRODUCT Lay's brand Classic Potato Chips, in 5 1/2 ounce bags. Recall #F-046-1. CODE Oct 3/48722307113. MANUFACTURER Frito-Lay, Inc., Fayetteville, Tennessee. RECALLED BY Frito-Lay, Inc., Plano, Texas, by visit beginning August 22, 2000. Firm- initiated recall ongoing. DISTRIBUTION Alabama, Mississippi, Tennessee, Georgia. QUANTITY 231 cases or 2,772 packages were distributed. REASON The bags labeled as "Classic Potato Chips" actually contain "Sour Cream and Onion Potato Chips." The "Sour Cream and Onion Potato Chips" contain dairy ingredients which are not listed on the "Classic Potato Chips" product’s label.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Bee's Queen brand Pure Chinese Honey in 10-ounce glass jars. Recall #F- 045-1. CODE None. MANUFACTURER Shanghai Native Produce I/E Corporation, Shanghai, China. RECALLED BY Wing Shing Hong Company, Inc., Brooklyn, New York, by telephone on December 13, 1999, Followed by visit. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Massachusetts, Pennsylvania, Connecticut, New Jersey. QUANTITY 208 cases (48 10-ounce jars per case) were distributed. REASON Product labeled as pure honey, but actually contained cane and/or corn sugar. ________ UPDATE Skinners Nuts Salted Red Pistachios (Skinner's Salted Nuts, Inc., Carlstadt, New Jersey), Recall #F-028-1, which appeared in the November 8, 2000 Enforcement Report is a Class III recall.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Rich's MSM Eye and Ear Drops (Methylsufonylmethane), in 1-ounce bottles. Recall #D-026-1. CODE All product (Product not coded). MANUFACTURER Rich Distributing, Portland, Oregon. RECALLED BY Manufacturer, by e-mail and mail on August 1, 2000, and by a mass mailing to be completed by September 6, 2000. Firm-initiated recall ongoing. See also FDA press release P00-16, August 11, 2000. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Microbial contamination (Pseudomonal fluorescens). ________ PRODUCT Tia-Cutz Capsules, Thyroid Stimulator, (1000 mcg Tiratricol), in 90-count containers, OTC indicated for use in weight loss and in conditions of obesity. Recall #D-027-1. CODE Lot 990426 EXP 12/01. MANUFACTURER Ultra Health Products, Phoenix, Arizona. RECALLED BY Gentech LLC, doing business as Gaspari Nutrition), Edison, New Jersey (responsible firm), by telephone on May 18 and 25, 2000, and June 5, 2000, and by letter on August 4, 2000. Firm-initiated recall complete. See also FDA talk paper T99-52, November 11, 1999. DISTRIBUTION Nationwide. QUANTITY 1,569 bottles were distributed; firm estimates none remains on the market. REASON Product is an unapproved new drug. ________ PRODUCT Sterile Talc Powder, in 100 mL vials, used to treat Malignant Pleural Effusion (MPE). Recall #D-028-1. CODE All lot numbers as follows: Non-sterile lot numbers: 9H010 and 9K012 Unapproved New Drug lot Numbers: Distribution Began Lot Number 10/14/97 (2 yr.exp.date) 7I008 03/27/98 8B004 07/31/98 8E005 11/18/98) 8I007 3/3/99 9B003 6/4/99 9D004 3/30/00 0A002 6/5/00 0E006. MANUFACTURER Sciarra Laboratories, Hicksville, New York. RECALLED BY Bryan Corporation, Woburn, Massachusetts, by letter dated September 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY Lot 9H010= 545 Cases (10 each) + 4 each Lot 9K012= 847 Cases (10 each) + 119 each Estimated at approximately 5,568 cases of the remaining 8 lots were distributed. REASON Non-sterile product. ________ PRODUCT a) Eyewash, Emergency Eye/Face Body Wash, Eyewash Concentrate and Normal Saline as follows: Lavoptik Brand manufactured by H.L. Bouton, Buzzards Bay, MA: Lavoptik Emergency Eye/Face/Body Wash in 16 oz. and 32 oz. Lavoptik Eye Wash in 6 oz. Lavoptik Eye Wash Concentrate For use in Portable Eye Wash Stations in 70 oz. and 180 oz. Rapid-Clear Brand distributed by Sellstrom, Palatine, IL: Rapid-Clear Eye Wash 16 oz., and 32 oz. and 128 oz Rapid-Clear Eye Wash Concentrate For Use in Portable Eye Wash Stations 180 oz. Zee Brand distributed by Zee Medical, Irvine CA Zee Protector II Refill Sterile Eye Wash Solution for Use in ZEE Protector II Eye Wash Station , 5 Qt b) Normal Saline Solution 16 oz. Recall #D-029/030-1. CODE All lots. MANUFACTURER H.L. Bouton Company, Inc., Buzzards Bay, Massachusetts. RECALLED BY Manufacturer, by letter on or about September 28, 2000, and by press release on September 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 40,000-50,000 units were distributed. REASON Microbial contamination (Bulkholderia cepacia).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Heparin Sodium Injection, USP, 5000 USP units per 0.5 mL in 1 mL tubex per 10,000 USP units, Rx. NDC #0008-0277-02. Recall #D-015-1. CODE Lot Numbers: 10945 EXP 02/01 and 10962 EXP 02/01. MANUFACTURER Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania (responsible firm). RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP), Columbus, Ohio (repacker/relabeler/distributor), by letter mailed on September 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio, New Jersey, Tennessee, Florida, Minnesota, Kentucky. QUANTITY 60 bags (1,500 vials) were distributed. REASON Lack of assurance of sterility. ________ PRODUCT Zagam(r) Tablets (Sparfloxacin), 200 mg, in 55-count bottles, Rx broad spectrum antimicrobial agent. NDC #62794-011-55. Recall #D-016-1. CODE Lot #MN4062 EXP 11/01. MANUFACTURER Aventis Pharma Ltd., Republic of Ireland. RECALLED BY Bertek Pharmaceuticals, Inc., Sugar Land, Texas, by letter on June 1, 2000, followed by telephone and fax on June 7, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 105 bottles were distributed; firm estimates none remains on the market. REASON Dissolution failure (6 months stability station testing). ________ PRODUCT a) Meperidine HCL Injection, USP, 75 mg per mL, 1 mL fill in 2 mL size, used for the relief of moderate to severe pain, preoperative medication, support of anesthesia, and obstetrical analgesia. NDC #0008-0605-2 and NDC #0008-0605-50; b) Heparin Sodium Injection, USP, 5,000 USP units per 0.5 mL fill in 1 mL tubex(r) 10,000 USP units per mL, Rx indicated for anticoagulant therapy. NDC #0008-0277-02. Recall #D-018/019-1. CODE Lot Numbers: a) 2990430 EXP 1/01 and 2990431 EXP 1/01; b) 2991816 EXP 2/01. MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania. RECALLED BY Manufacturer, by letter on September 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 350,490 tubexes; b) 186,390 tubexes were distributed. REASON Current good manufacturing practice deviations (lack of assurance of sterility).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Allegra(r) Tablets (fexofenadine HCL), 60 mg, physician sample units, Rx for the releif of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older, and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Recall #D-010-1. CODE Lot #1021570 EXP 032002 Lot #1022502 EXP 102102 Lot #1021572 EXP 101802 Lot #1023169 EXP 110602 Lot #1021573 EXP 102002 Lot #1022714 EXP 032002 Lot #1022501 EXP 102102. MANUFACTURER Aventis Pharmaceuticals, Inc., Kansas City, Missouri. RECALLED BY Manufacturer, by voice mail on June 28, 2000, and by E-mail letters on June 30, 2000, and July 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 207,878/30 2-tablet card boxes were distributed. REASON Mislabeling - The label bears unapproved dosage instructions for patients other than adults. ________ PRODUCT Estratab(r) Tablets (Esterified Estrogens Tablets, USP), 2.5 mg, in 100- count bottles. NDC #0032-1025-01. Recall #D-014-1. CODE All lots. MANUFACTURER Solvay Pharmaceuticals, Baudette, Minnesota. RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia, by letter on August 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 16,418 units were distributed. REASON Firm withdrawal of application (stability data). ________ PRODUCT Nortriptyline Hydrochloride Capsules, USP 25 mg, in 500-count bottles, Rx. NDC #0364-2509-02. Recall #D-017-1. CODE Lot #P9E0175 EXP 5/01. MANUFACTURER Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaceutical, Inc., Humacao, Puerto Rico. RECALLED BY Manufacturer, by priority mail on September 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 6,756 bottles were distributed. REASON Dissolution failure (stability). ________ PRODUCT Pipracil, Rx indicated for the treatment of serious infections caused by susceptible strains of designated organisms; Zosyn 3 gram/0.375 gram: indicated for the treatment of patients with moderate to severe infections caused by peperacillin-resistant, piperacillin/tazobactam- susceptible, beta-lactamase producing strains of designated microorganisms: a) Pipracil(r) 3 gram ADD-Vantage(r) vials (Piperacillin Sodium), For IV Use; b) Pipracil(r) 4 gram ADD-Vantage(r) vials (Piperacillin Sodium), For IV Use; c) Zosyn(r) 3.375 gram ADD-Vantage(r) vials (Sterile Piperacillin and Sodium Tazobactam Sodium), For IV Use. Recall #D-020/022-1. CODE Lot Numbers: a) 426-116 EXP 4/01; b) 426-149 EXP 6/01, 464-675 EXP 2/02, 800-118 EXP 6/02; c) 800-048 EXP 4/03. MANUFACTURER Lederle Piperacillin, Inc., Carolina, Puerto Rico. RECALLED BY Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania, by letter on October 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 21,422 units were distributed between July 1999 - September 2000. (Pipracil 3 gram 5,022 units, Pipracil 4 gram 15,566 units and Zosyn 5, 424 units). REASON Vial breakage. ________ PRODUCT Pueblo Xtra brand Isopropyl Alcohol, 70% Rubbing Alcohol, in 16-fluid ounce bottles. Recall #D-023-1. CODE Lot Numbers: B125 and B143. MANUFACTURER Omega, Inc., Carolina, Puerto Rico. RECALLED BY Manufacturer, on October 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 7,200 units were distributed. REASON Mislabeling - Product bears both the correct label strength of 70% and an incorrect label declaration of 50%. ________ PRODUCT a) Duphalac(r) (Lactulose Solution, USP), 10 g/15mL, in 8, 16, and 32- fluid ounce units; b) Duphalac(r) (Lactulose Solution, USP), 20 g/30mL, in 30mL unit dose cups. Recall #D-024/025-1. CODE All lots within expiration date. MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette, Minnesota. RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on August 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,814,103 units were distributed. REASON Firm withdrawal of application (stability data).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-177/181-1. CODE Unit Numbers: a) 1623716, 1575633, 1540205, 1532107, 1443918; b) 1532107; c) 1540205, 1532107; d) 1575633, 1443918, 1623716; e) 1623716, 1575633, 1443918. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated August 23, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky and Maryland. QUANTITY a) 5 units; b) 1 unit; c) 2 units; d) 3 units; e) 3 units were distributed. REASON Blood products were collected from a donor who traveled to an HIV Group O risk area. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Platelets; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma; f) Plasma, Cryoprecipitate Removed; g) Platelets, For Use In Manufacturing Non- injectable Products; h) Recovered Plasma for Manufacturing Non-injectable Use; i) Recovered Plasma j) Red Blood Cells For Manufacturing Use Only. Recall #B-243/252-1. CODE Unit Numbers: a) 33254, 61904, 81154, 93768, 114908, 122387, 141076, 142063, 142928, 144116, 146672, 146966, 151538, 153173, 162436, 198471, 199887, 212127, 225424, 236591, 236943, 259493, 260511, 261441, 264431, 269709, 271352, 275619, 275909, 286843, 305116, 309324, 313558, 320674, 322027, 328252, 334154, 336309, 336566, 346491, 350474, 356253, 363109, 385074, 391255, 405154, 422542, 433187, 436137, 446142, 450031, 475653, 480487, 492733, 493991, 505254, 0549846, 0557471, 0572366, 0580525, 0590047, 0591611, 0626189, 0637137, 0638018. b) 255096, 286289, 381093, 0605622, 0615745, 0523966 c) 33254, 61904, 93768, 122387, 141076, 142063, 144116, 146672, 146966, 151538, 153173, 162436, 198471, 212127, 225424, 236943, 260511, 261441, 264431, 269709, 275909, 286289, 286843, 313558, 320674, 328252, 336309, 336566, 350474, 356253, 381093, 385074, 391255, 422542, 436137, 446142, 480487, 492733, 505254, 0557471, 0572366, 0605622, 0615745, 0638018, 0523966, 0549846, 0637137, 9008508 d) 199887, 322027, 275619, 9002498, 9003200, 9005860, 9007402, 9008322, 9012466, 9401051, 9402023 e) 93768, 142063, 146672, 146966, 153173, 225424, 255096, 260511, 264431, 275909, 286289, 286843, 336309, 336566, 350474, 356253, 381093, 385074, 391255, 405154, 436137, 475653, 492733, 0523966, 0572366, 0637137, 0638018 f) 275619, 9009621, 9012466, 9401053 g) 236591, 255096, 405154, 405201, 433187, 475653, 493991, 0591611 h) 2345, 15748, 117920, 139369, 238588, 242145, 267471, 269131, 274131, 276821, 276872, 392600, 393147, 393966, 431541, 450031, 0524652, 0591611, 9002498, 9003200, 9005860, 9007402, 9008322 i) Units 10385, 81154, 114908, 141076, 142928, 144116, 151538, 199887, 212127, 236591, 236943, 239938, 243991, 259493, 261441, 269709, 271352, 305116, 309324, 313558, 320674, 322027, 328252, 334154, 346491, 363109, 405201, 422542, 446142, 480487, 493991, 505254, 0557471, 0580525, 0590047, 0605622, 0615745, 0626189; j) 405201. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letters dated June 15, 21, 22, 28, and 29, 1999. Firm- initiated recall complete. DISRIBUTIUON Minnesota, Mississippi, California, Texas, Florida, Pennsylvania, New York, Switzerland. QUANTITY 59 units; b) 6 units; c) 48 units; d) 11 units; e) 27 units; f) 4 units; g) 8 units; h) 23 units; i) 38 units; j) 1 unit distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1 or anti- HIV 1/2. _______ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets, Pooled; d) Platelets, Pheresis, Leukocytes Reduced; e) Fresh Frozen Plasma; f) Recovered Plasma. Recall #B-284/289-1. CODE a) KM18724, KM20631, KM23192; b) KM21839; c) PO2060; d) KM24177; e) KM21839; f) KM18724, KM20631. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by letters dated August 15, 2000, on December 10, 1999, and by fax August 16, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin and Switzerland. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit; f) 2 units were distributed. REASON Blood products were collected from a donor having been diagnosed with Sarcoidosis. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-290-1. CODE Unit numbers: KM206521-1, KM206521-2, LH53726-1, LH53726-2, LH54278, LW85817-1, LW85817-2, R07225. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on August 11 & 14, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 8 units were distributed. REASON Blood products had unacceptable platelet counts. ________ PRODUCT Indicator Red Cells. Recall #B-299-1. CODE Lot number 20549, included with Capture-CMV (Lots 20585, 20586, and 20587) and Capture-S Test Kits (Lots 20588 and 20589. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by telephone and fax on May 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Italy, Spain. QUANTITY 405 test kits were distributed. REASON Indicator red cells exhibited loss of anti-IgM activity.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Source Plasma. Recall #B-220-1. CODE Unit #98OWIE4986. MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by fax dated December 22, 1998. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had a Hepatitis B immunization one day prior to the date of donation. ________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-293/294-1. CODE Unit #13GQ11638. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on July 23, 1998, and by letter on July 29, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON A unit of red blood cells implicated in a transfusion reaction was found to be contaminated with gram positive cocci. Corresponding blood products were distributed. ________ PRODUCT Capture-S Reactive Control. Recall #B-298-1. CODE Lot Numbers: QA3633, included with Capture-S Test Kits, lots 12399, 14446, 16493, 18541, 20589, 22636, 24684, 12397, 14445, 16492, 18540, 20588, 22635, 24683. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by letter dated May 12, 2000, or by telephone or fax on June 12, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide, Italy, Spain, Republic of Georgia. QUANTITY 585 test kits were distributed. REASON Reactive control serum exhibit loss of reactivity. ________ PRODUCT Reagent Red Blood Cells, Panocell-10, Ficin Treated. Recall #B-300-1. CODE Lot #30285-E. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by letter dated July 29, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide, Canada, Italy, Germany. QUANTITY 197 sets were distributed. REASON Ficin solution have a shorter expiration date than the accompanying reagent red blood cells.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Hydrajust IV Urological Table. Recall #Z-001-1. CODE All Serial Numbers are affected for Part Numbers: 400001, 400002, 400005, 400006, 400007, 400008, 400011, 400012, 400015, 400016, and 400017. The Serial Numbers affected for Part Number 400025 are: 3496-0503, 3496-0504, 3596-0506, 3596-0507, 3896-0510, 4596-0512, 4796-0513, 4796-0514, 5196- 0516, 5196-0517, 5196-0518, 5296-0519, 0397-0522, and 0397-0524. The Serial Numbers affected for Part Number 400026 are: 0797-0501, 1196-0502, 3496-0505, 3596-0508, 3996-0511, 4796-0515, 0297-0520, 0397-0521, and 0397-0523 MANUFACTURER Mallinckrodt, Inc., Liebel-Flarsheim Business, Cincinnati, Ohio. RECALLED BY Mallinckrodt, Inc., Liebel-Flarsheim Business, Cincinnati, Ohio, by Certified Mail on June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 450 units were distributed. REASON A mechanical failure may allow the table and tube arm to freely rotate downward and injure a patient. ________ PRODUCT Steri-Oss brand, Non-Hexed Cylindrical Implants (Endosseous Implants), HA Coated, 3.25D by 12mm, Catalog #2612H, decives that are surgically placed in the upper or lower jaw arches to provide support for a prosthetic device, such as artificial teeth and to restore the patients chewing function. Recall #Z-027-1. CODE Lot #993683. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter dated August 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Kentucky, Louisiana, Ohio, New Jersey, New York, Utah. QUANTITY 59 units were distributed. REASON Some of the inner vial labels were incorrectly placed on the 3.25 x 14mm implants, catalog #3214TPS, lot 993719. ________ PRODUCT ECG Electrodes intended for use during electrocardiographic procedures: a) InvisaTrace 1680, Radiotranslucent Clear Tape ECG Electrode, sold as follows: Catatalog #1680-001, 1 per pouch, 30 per box, 600 per case Catatalog #1680-005, 5 per pouch, 50 per box, 600 per case, Cat. #1680- 030, 30 per pouch, 600 per case; b) UltraTrace 1690, Clear Tape ECG Electrode, multi-purpose for short or long term use. The product insert identifies this as an adult long-term monitoring electrode and describes long term use as 5-7 days. Sold as follows: Catalog #1690-001, 1 per pouch, 30 per box, 600 per case, Catalog #1690-003, 3 per pouch, 30 per box, 600 per case, Catalog #1690-005, 5 per pouch, 30 per box, 600 per case, Catalog #1690-010, 10 per pouch, 50 per box, 1000 per case, Cat. #1690-030, 30 per pouch, 600 per case. Recall #Z-028/029-1. CODE a) InvisaTrace Model No. 1680 Series, Radiotranslucent Clear Tape ECG Electrode; Catalog No. 1680-001, Lot Codes 9909211, 9910071, 9910081; Catalog No. 1680-005, Lot Codes 9909181, 9909231, 9910081; Catalog No. 1680-030, Lot Codes 9909231, 9909232, 9909271, 9909272, 9909291, 9909292, 9910011, 9910012, 9910052, 9910061, 9910082, 9910131; b) UltraTrace Model 1690 Series, Clear Tape ECG Electrode, Catalog No. 1690-001, Lot Codes 9909301, 9910261, 9910262; Catalog No. 1690-003, Lot Codes 9909201, 9909202, 9911011; Catalog No. 1690-005, Lot Codes 9909131, 9910121, 9910122, 9910132, 9910141, 9910142, 9910192, 9910221; Catalog No. 1690-010, Lot Codes 9909071, 9910051, 9909211, 9909231, 9909241, 9910261, 9910262, 9910291; Catalog No. 1690-030, Lot Codes 9909141, 9909141, 9909152, 9909161, 9909252, 9909291, 9910041, 9910052, 9910071, 9910081, 9910151, 9910202, 9910262, 9910271, 9911031, 9911041. MANUFACTURER Conmed Corporation, Rome, New York. RECALLED BY Conmed Corporation, Utica, New York, by letters dated September 20, 2000, and by fax on September 21-22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Australia, Canada, Germany, Japan, The Netherlands, Spain, Taiwan. QUANTITY a) 737 cases; b) 1,911 cases. REASON Some electrodes in these lots may exhibit a separation of the sensing element from the body of the electrode, causing the electrode not to function. ________ PRODUCT Escort E300 Series Patient Monitor, intended use is as an electrocardiograph and respiration monitor. Recall #Z-030-1. CODE Serial numbers are non-sequential (there are gaps), are four digits long and include: 1001 to 4086. MANUFACTURER Medical Data Electronics, Arleta, Georgia. RECALLED BY Manufacturer, by letter dated July 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Belgium, Canada, Czech Republic, England, Finland, France, Greece, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, Norway, Russia, South Africa, Sweden, Switzerland, Taiwan, ROC, Turkey, United Arab Emirates, United Kingdom. QUANTITY 483 units were distributed. REASON It is possible for the High Breath Rate Alarm to function incorrectly under certain conditions. ________ PRODUCT Pulse Generators, intended for the treatment of Bradycarcdia: a) META DDR, Model No. 1256D Pulse Generator; b) TEMPO VR, Model No. 1102 Pulse Generator; c) TEMPO V, Model No. 1902 Pulse Generator; d) TEMPO DR, Model No. 2102 Pulse Generator; e) TEMPO D, Model No. 2902 Pulse Generator. Recall #Z-031/035-1. CODE Serial numbers from U6100663 to U6227334. MANUFACTURER Teletronics Pacing Systems, Miami Lakes, Florida. RECALLED BY St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California. DISTRIBUTION Nationwide and international. QUANTITY 10,345 devices were distributed. REASON Dendritic growth at the battery/hybrid connection could cause a short circuit, which in turn could result in premature battery depletion. ________ PRODUCT Thoracentesis/Paracentesis Kits (Sterile), Catalog #TPK1001, intended use is to perform Thoracemtesis and Paracemtesis procedures using a needle to remove thoracic fluid. Recall #Z-038-1. CODE Lot #L0B070. MANUFACTURER Allegiance Healthcare Corporation, El Paso, Texas. RECALLED BY Manufacturer, by letter on September 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 156 kits were distributed. REASON Unsterilized kits labeled as sterile. ________ PRODUCT CryoValve Allograft, human heart valve replacement implant. Recall #Z- 039/040-1. CODE Model Number AV00 - Serial Number 3832821; Model Number PV00 - Serial Number 3832848; Model Number PV00 - Serial Number 3978893; Model Number AV00 - Serial Number 6011365; Model Number PV00 - Serial Number 6011373. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on July 21 and 24, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Texas, Maryland, California, Kentucky. QUANTITY 5 valves were distributed. REASON Donors did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids. ________ PRODUCT Custom Procedure Trays, for use in cardiopumonary bypass. Recall #Z-041- 1. CODE All lot numbers. All product produced in the Junior Tray Configuration which has been in production since January 1999. MANUFACTURER Edwards Life Science L.L.C., Irvine, California. RECALLED BY Manufacturer, by letter on or about July 19, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington state, District of Columbia. QUANTITY Firm estimates none remains on the market. REASON The sterility of the product cannot be assured due to reports of some open seals. ________ PRODUCT a) SDL-FL-10/20 Series Fiber Laser; b) SDL-FD-25 Fiber Coupled Laser Systems, diode laser systems used as laser marking systems. Recall #Z- 048/049-1. CODE Model SDL-FL10/20 and SDL-FD25. MANUFACTURER SDL Inc., San Jose, California. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on November 2, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 293 units; b) 40 units were distributed. REASON The laser product failed to comply with the Federal laser product performance standard, 21 CFR 10 40.10(f)(4). The key could be removed from the key control of the laser systems when the key was in the "On" position. ________ PRODUCT Various models of SSCOR powered suction pumps used exclusively by professional personnel trained in the techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter: a) Suction Unit, Model No. 10552; b) Suction Unit, Model No. 15002; c) Suction Unit, Model No. 2500; d) Suction Unit, Model No. 40014; e) Suction Unit, Model No. 45000; f) Suction Unit, Model No. 64000; g) Suction Unit, Model No. 64000-220; h) Suction Unit, Model No. 90024; i) Suction Unit, Model No. 90032. Recall #Z-050/058-1. CODE a) Serial Nos. 2655 - 3152; b) Serial Nos. 628 - 3603; c) Serial Nos. 250 - 887; d) Serial Nos. 5802 - 6499; e) Serial Nos. 1094 - 1142; f) Serial Nos. 4881 - 8381; g) Serial Nos. 1008 - 1128; h) Serial Nos. 1854 - 2290; i) Serial Nos. 2216 - 2388. MANUFACTURER SSCOR, Inc., Sun Valley, California. RECALLED BY Manufacturer, by letters beginning on June 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Mexico, Canada, Philippines, Chili. QUANTITY 6,354 units were distributed. REASON Presence of hairline cracks in the plastic fuse holders which house a fuse required to recharge the suction unit.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Cardiac T Rapid Assay, Catalog #5740200, intended for use in the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood. Recall #Z-037-1. CODE All lot numbers. MANUFACTUER Roche Diagnostics, GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter on September 29, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Sodium fluoride interferes with the assay and results in falsely low values. ________ PRODUCT a) Cardiac M Assay, Catalog #1893840, intended for use with the cardiac reader analyzer to provide rapid and quantitative measurements of cardiac troponin T; b) Cardiac T Quantitative Assay, Catalog #1894307, for use with the cardiac reader analyzer to provide rapid and quantitative measurements of cardiac troponin T. Recall #Z-042/043-1. CODE All lots. MANUFACTURER Roche Diagnostics, GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by issuing an urgent product correction on September 29, 2000. Firm-initiated field correction. DISTRIBUTION Massachusetts. QUANTITY Undetermined. REASON The use of blood collection devices containing sodium fluoride cause falsely low results. ________ PRODUCT a) Precical, Catalog Nos. 620213 and 917213, a lyophilized preparation of pooled human sera for use as a calibrator of clinical chemistry assays; b) Precitrol A, Catalog Nos. 620211 and 917211; c) Precitrol N, Catalog Nos. 620212 and 917212, lyophilized preparations of pooled human sera for use as a control of clinical chemistry assays. Recall #Z-044/046-1. CODE Lot Numbers: a) 750001 and 750002; b) 770001, 770002, and 770003; c) 760001, 760002, and 760003. MANUFACTURER Roche Diagnostics Corporation, Indianapolis, Indiana. RECALLED BY Manufacturer, by customer bulletin on May 15, 2000 and August 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 58,086 Precial and 878,692 Precitrol A and N. REASON A negative bias was observed when using the calcium setpoint associated with these lots of calibrators.END OF ENFORCEMENT REPORT FOR NOVEMBER 22, 2000. ####
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