June 14, 2000 00-24RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Tree of Life Organic Trail Mix: a) in 6-ounce, plastic bags; b) 25-pound bulk product in a corrugated box with the date of manufacturer on the tape of the box. Recall F-474-0. CODE a) Item #2335701, UPC code 0 30684 335709, with the following expiration dates on the back: 24600, 05401, 08101. b) Item #175091, UPC code is 0 30684 17509 1, with the following dates of manufacture: 10-14-99, 12-6-99, 12-7-99, 12-17-99, 01-13-00, 03-02-00, 03-09-00, 03-17-00, 04-13-00, 04-15-00. MANUFACTURER Tree of Life, St. Augustine, Florida. RECALLED BY Manufacturer, by telephone on April 27, 2000, and followed by letter on April 28, 2000 and press release on May 3, 2000. Firm-initiated recall complete. DISTRIBUTION Eastern United States and Arizona. QUANTITY a) 1974 units; b) 270 boxes were distributed. REASON The product contains undeclared peanuts. ________ PRODUCT a) Danish Rye Bread; b) German Rye Bread; c) Caraway Rye Bread; d) Large Round Rye Bread in loaves which have a declared net weight of 1-pound 8-ounces; e) Assorted Hard Rolls in individual weight packages. Recall #F-498/502-0. CODE All lots distributed prior to April 28, 2000. MANUFACTURER O & H Danish Bakery, Inc., Racine, Wisconsin. RECALLED BY Manufacturer, by letter, hand delivered on April 28, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY Approximately 300-pounds were distributed. REASON Products contained undeclared eggs. ________ PRODUCT Pudding Mixes and Salads: a) 1) Instant Pistachio Pudding Mix, packed in retail cartons, 24 cartons per case, distributed under the following brand labels: Kroger (3.5 oz and 5.25 oz sizes), Best Choice (3.5 oz), Fry's (3.5 oz), and Safeway (3.4 oz), and 50 LB bulk containers; b) No Sugar Added Instant Pistachio Pudding Mix, packed and distributed under the Kroger label, in 1.1 oz retail cartons, 24 per case; c) Watergate Salad, distributed under the Kroger Delicatessen Bright Sides label, packed in 11 oz retail containers, 12 per case; and Watergate Salad distributed under the Deli Chef label, packed in 6 LB bulk containers; d) Pistachio Pineapple Delight packed and distributed under the Deli Chef label, in 7-LB bulk containers. Recall #F-504/507-0. CODE The Sell-By dates for the Instant Pistachio Pudding Mixes are: "DEC0200 to MAR2401" (Kroger label, 1.1 oz, 3.5 oz, 5.25 oz); "122299 and 030100" (Kroger label, 50 LB bulk); "FEB2401 to APR2101" (Best Choice label, 3.5 oz); "DEC3000 to APR2101" (Fry's label, 3.5 oz); and "DEC02000 to MAR2401" (Safeway label, 3.4 oz). The Sell-By dates for the Watergate Salads are ì3/16 to 4/20î (Kroger Bright Side, 11 oz); 3/22 to 4/25" (Deli Chef, 6 LB). The Sell-By date for the Pistachio Pineapple Delight is: "3/16 to 4/24" (Deli Chef, 7-LB). MANUFACTURER Kenlake Foods, Murray, Kentucky (pudding mixes) and K.B. Specialty Foods, Greenburg, Indiana (salads). RECALLED BY The Kroger Company, Cincinnati, Ohio, by fax and E-mail on March 31, 2000, and April 4, 2000, and by press release on March 31, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a&b) 14,369 cases; c) 717 cases; d) 2,576 cases were distributed. REASON Products may contain undeclared peanuts. ________ PRODUCT Lucerne Mud Pie Ice Cream, packaged in paperboard square half-gallon cartons. Recall #F-508-0. CODE Best Before NOV 06 00. MANUFACTURER Safeway, Inc., Bellevue, Washington. RECALLED BY Safeway, Inc., Pleasanton, California, by E-mail and press release on March 29, 2000. Firm-initiated recall complete. DISTRIBUTION Alaska, California, Hawaii, Nevada, Idaho, Montana, Oregon, Washington state. QUANTITY Undetermined. REASON The product contains undeclared peanuts. The cartons labeled as "Mud Pie Ice Cream" actually contain a second product, "Goo Goo Clusters Ice Cream" which contains peanuts as an ingredient. Peanuts are not listed as an ingredient on the Mud Pie Ice Cream carton.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Sandwiches wrapped in cellophane: a) Vegetable; b) Chicken Salad; c) Turkey; d) Italian Salame; e) Roast Beef. Recall #F-475/479-0. CODE 0505 on a white sticker label. MANUFACTURER Paninis From Heaven, Bellevue, Washington. RECALLED BY Manufacturer, by visit May 4 and 5, 2000. Firm-initiated recall completed. DISTRIBUTION Washington state. QUANTITY Approximately 3,500 sandwiches on a weekly basis. REASON Products contain undeclared eggs as a component ingredient of mayonnaise. ________ PRODUCT Various bulk human grade mineral nutrition products, packaged in 55-lb. drums: a) Calcium Citrimal, 20.4% Ca b) Cardio Health Premix c) Carlson Multi Mineral Glycinate d) Copper Chelazome Amino Acid Chelate, 2.57% Cu e) Magnesium Amino Acid Chelate Buffered f) Magnesium-Calcium (1:1) Tablet Powder g) Magnesium Chelazome Amino Acid Chelate h) Magnesium Citrate, 18.1% Mg i) Magnesium Creatine j) Male Multi k) Meta Mag #1, 10.5% Mg l) Meta Mag #3 m) Mineral Essence Blend n) Potassium Amino Acid Complex o) Potassium Aspartame p) Solamins Chelated Mineral Blend q) VM 75 Prime Mineral Blend r) Zinc Chelazome Amino Acid Chelate. Recall #F-480/497-0. CODE Lot numbers: a) Lot No. 201011; b) 0090A; c) 0087B; d) 0104A, 200881; e) 200911, 200941, 200951; f) 0077B, 0112A; g) 201021; h) 201171; i) 200871, 201181; j) 0112B; k) 201031; l) 200841, 200842, 201051, 201101 m) 0075C, 0087A, 0112C; n) 201231; o) 201151; p) 0125A, 0125B; q) 0090B, 0117A, 117B; r) 0101A, 0102A, 200771. MANUFACTURER Albion Laboratories, Inc., Clearfield, Utah. RECALLED BY Manufacturer, by fax and letter on May 17-18, 2000, followed by telephone beginning on May 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Colorado, Florida, Georgia, Illinois, Montana, New Jersey, New York, Ohio, Philadelphia, Texas, Utah, Washington state and Wisconsin, Australia, Brazil, Canada, Guatemala, Lebanon and United Kingdom. QUANTITY 42,253-pounds were distributed. REASON The products are contaminated with pieces of wire.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Brethaire(r) Inhalation Aerosol (Terbutaline sulfate,) 7.5 mL, Complete Unit, NDC #0028-5557-88, and 7.5 mL refill, NDC #0028-5557-87, Rx inhaler for relief of reversible bronchospasm in patients with obstructive airway disease such as asthma, bronchitis, and emphysema. Recall #D-192-0. CODE Lot numbers: 1971259, 2971259 and 4971259, 3971259 EXP 11/99. MANUFACTURER 3M Pharmaceuticals, Northridge, California. RECALLED BY Novartis Pharmaceuticals Corporation, Suffern, New York, by faxed letter on September 29, 1999, and by mail on October 5, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 9,210 - lot 1971259 23,904 - lot 2971259 26,982 - lot 4971259 11,982 - lot 3971259 lots were distributed. Firm estimates none remain on market. REASON Aerodynamic particle size failure (stability). ________ PRODUCT a) Acetone Alcohol in preps (CS-1000-VWR Catalog #15649-000), Swabs (CS-500-VWR-15649-012); b) Iodophor in swabs (PVP-50-VWR Catalog #15649-002 and 500 C/S Catalog #15649-018), pads (PVP Prep 200 pack VWR Catalog #15649-016); c) Iodine Tinc. in Swabs (VWR Catalog #15649-006 and 010) and sol ptns 12x16 oz. Pack (VWR Catalog #15649-034); d) Alcohol in swabs 25 pack (VWR Catalog #15649-008 and LX15649-008) and prep pads Med NS 20 pack (VWR Catalog #15649-024) and Towelette Clinipad (VWR Catalog #15649-014); e) Povodone Iodine in Scrub/Gal 4 CS (VWR Catalog #15649-030) and Gal (VWR #BA15649-030AB); f) Benzalkonium Chloride 1/2-oz. (VWR Catalog #15649-028); g) Green Soap Tinc. in swabs, 500/CS (VWR #15649-020). Recall #D-397/403-0. CODE All lots. MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. RECALLED BY VWR Scientific Products Corporation, West Chester, Pennsylvania, by letter on April 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Connecticut, Georgia, Illinois, Indiana, Maryland, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania, Texas. QUANTITY 133 units were distributed. REASON Manufacturer (Clinipad Corporation) unable to assure product meets release microbiological specifications.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Imitrex(r) (sumatriptan succinate) Rx tablets, 25 mg, in 9-tablet units. NDC #0173-0460-02. Recall #D-393-0. CODE Lot Numbers: OZP0151 and OZP0152. MANUFACTURER Glaxo Wellcome, Zebulon, North Carolina. RECALLED BY Manufacturer, by letter on April 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 12,157 units from lot OZP0151, and 25,553 units from lot OZP0152 are in distribution channels. REASON Misbranding - Blister text incorrectly declares product strength at 50 mg (outer carton is correctly labeled (25 mg). _______ UPDATE Quinidine Gluconate Extended Release Tablets, USP, 324 mg, in 100 and 500 tablet bottles, recalled by Schein Pharmaceuticals, Inc., Brewster, New, which appeared in the January 19, 2000 Enforcement Report has been extended to include Lot Numbers C8E1069 and C8F1172. ________ PRODUCT a) Doxycycline Hyclate Capsules, USP, 50 MG in bottles of 50, NDC 0364-2032-50, and bottles of 100 (10 X 10), NDC 0364-2033-90; b) Doxycycline Hyclate Capsules, USP 100 MG in bottles of 50, NDC 0364-2033-50, and bottles of 500, NDC 0364-2033-05. Recall #D-394/395-0. CODE LOT NUMBER EXP. DATE P9A0015 JAN 01, BOTTLES OF 50 P9A0015 OCT 00, UNIT DOSE P9A0018 JAN 01, BOTTLES OF 50 & 500 MANUFACTURER Danbury Pharmacal Puerto Rico, Inc., Subsidiary of Schein Pharmaceutical, Inc., Humacao, Puerto Rico. RECALLED BY Manufacturer, by letter on May 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 9,378 bottles of 50, and 745 unit dose cartons of 100; b) 13,781 bottles of 50 and 4,302 bottles of 100 were distributed; firm estimated fewer than 0.1% of the product remained on market at time of recall initiation. REASON Stability; Product Fails (Exceeds) USP water content at 9 month test point.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets, Pheresis. Recall #B-746-0. CODE Unit #11LL01916. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on November 19, 1999, and by letter dated January 6, 2000. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASON Blood product was mislabeled as CMV antibody negative. ________ PRODUCT Red Blood Cells. Recall #B-747-0. CODE Unit #11T42174. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated September 17, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Zovirax. ________ PRODUCT a) Red Blood Cells. Recall #B-748-0. CODE Unit #53GL02248. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated December 22, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had taken the drug Evista. ________ PRODUCT Red Blood Cells. Recall #B-751-0. CODE Unit numbers: 11C12366, 11C02195. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letters dated June 10, 1999, July 8, 1999, and August 13, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 2 units were distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Red Blood Cells. Recall #B-752-0. CODE Unit #011KE09311. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on May 4, 1999, and letters dated May 18, 1999 and June 14, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who lived in an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-753-0. CODE Unit Numbers: 11GN17559 and 11GL14581. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated August 18, 1999, and by telephone on August 9, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri, Illinois. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who had traveled to an area designated as endemic for malaria. _____ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-754/756-0. CODE Unit #11GK04360. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letters dated May 10, 1999, and June 16, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri, Alabama, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Source Plasma. Recall #B-768-0. CODE Unit Numbers: N-06825-178, N-06840-178, G-23972-178, G-24173-178, G-24496-178. MANUFACTURER Seramed Bio Center/Melrose Park, Melrose Park, Illinois. RECALLED BY Manufacturer, by fax on December 16, 1999. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 5 units were distributed. REASON Blood products were collected from a donor who was previously deferred for a positive drug screen. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-780/784-0. CODE Unit Numbers: a) 11GW06470, 11GQ07524, 11GQ03720; b) 11GQ07524; c) 11GQ03720; d) 11GQ03720; e) 11GW06470. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letters dated September 16 or 27, 1999, and October 22, 1999 or November 5, 1999, and by fax on September 20, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri, Arkansas, Massachusetts, California. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit. REASON Blood products were collected from a donor with multiple high risk behaviors. ________ PRODUCT Platelets, Pheresis. Recall #B-785-0. CODE Unit #0334132-A. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by letter dated March 15, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product with an unacceptable platelet yield, was distributed labeled as a standard product. ________ PRODUCT Platelets, Pheresis. Recall #B-786-0. CODE Unit #0335424. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on February 12, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product, which was not leukoreduced, was distributed, labeled as leukoreduced. ________ PRODUCT Platelets, Pheresis. Recall #B-787-0. CODE Unit #42KP02164 (split unit). MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated March 27, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio, Pennsylvania. QUANTITY 1 split unit was distributed. REASON Blood products exceeded the maximum criteria for platelet yield. ________ PRODUCT Platelets, Pheresis. Recall #B-788-0. CODE Unit #04LP40177. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on December 6, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product, with a volume that exceeded specifications, was distributed in one bag instead of two, as required.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Platelets; b) Fresh Frozen Plasma. Recall #B-665/666-0. CODE Unit Numbers: 39J82095, 39J86372, 39G87845. MANUFACTURER American Red Cross, Huntington, West Virginia. RECALLED BY Manufacturer, by letters dated October 12, 1999 and/or November 12, 1999. Firm-initiated recall complete. DISTRIBUTION West Virginia, Kentucky. QUANTITY 3 units of each component were distributed. REASON Blood products were prepared from whole blood units that had discrepant start and end times documented. ________ PRODUCT Red Blood Cells. Recall #B-716-0. CODE Unit #16LR31902. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on February 1, 2000, followed by Letter dated February 3, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was leukoreduced greater than five days after collection. ________ PRODUCT Red Blood Cells. Recall #B-745-0. CODE Unit #011GS30771. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on January 28, 1999, and letter dated February 5, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning a post donation illness. ________ PRODUCT Recovered Plasma. Recall #B-749-0. CODE Unit #53GL02248. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by "Questionable Plasma Inquiry" on January 13, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had taken the drug Evista. ________ PRODUCT Source Leukocytes. Recall #B-765-0. CODE Unit #11GM25063. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letters dated November 22, 1999, December 22, 1999, and January 25, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose medical history screening was inadequately performed. ________ PRODUCT Platelets, Pheresis. Recall #B-769-0. CODE Unit #R30941. MANUFACTURER HCSC Blood Center, trading as Miller Memorial Blood Center, Bethlehem, Pennsylvania. RECALLED BY Manufacturer, by telephone on November 30, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product, which had invalid quality control results, was distributed labeled as a standard product.RECALLS AND FIELD CORRECTIONS: DEVICES -- II
________ PRODUCT a) Bennett X-Ray Contour Mammography Systems, Model numbers: M-CTR-2000, M-CTR-2000-3P, M-CTR-P, M-CTR-3P; b) Profile Mammography Systems, Model numbers: M-PRO-2000, M-PRO2000-3P, M-PRO, diagnostic X-ray devices used in mammography. Recall #Z- 739/740-0. CODE None MANUFACTURER Bennett X-ray Corporation, Danbury, Connecticut. RECALLED BY Trex Medical Corporation, Danbury, Connecticut. FDA approved the firmís corrective action plan on May 26, 2000. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 607 units were distributed. REASON The units are noncompliant with 21 CFR 1020.31(m) in that the transmission limit 5-cm beyond the plane of the image receptor support device exceeds 0.1 mR per exposure. This can result in the patient receiving unnecessary exposure. ________ PRODUCT Model Gallium Elite and Midi Laser System, for use in pain therapy for animals. Recall #Z-777-0. CODE None. MANUFACTURER Sim-Med Ltd., United Kingdom. RECALLED BY Manufacturer. FDA approved the firmís corrective action plan on May 22, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Florida, Alaska. QUANTITY 3 units of each model were distributed. REASON The device failed to comply with 21 CFR 1010.2, 1010.3, and 1040.10 (f) (6) (i) in that the products lack required certification and identification and compliance with the beam attenuator requirement. ________ PRODUCT Vacutainer Brand Evacuated Blood Container, partial draw sodium citrate tubes. Recall #Z-778-0. CODE Catalog Numbers: 369711, 369700, 367712, 367703, 367715, 366416, 369705, 367707, 366419. MANUFACTURER Becton Dickinson & Co., Broken Bow, Nebraska. RECALLED BY Becton Dickinson & Company, Franklin Lakes, New Jersey, by providing technical information to users beginning April 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Not applicable. REASON Increased platelet activation in partial draw tubes. ________ PRODUCT Procedure Tray, Fixture Installation, Catalog #25369, dental handpiece and accessories. Recall #Z-779-0. CODE Lot numbers: 802899, 803109, 803183, 803237, and 803711. MANUFACTURER Nobel BioCare AB, Gothenburg, Sweden. RECALLED BY Nobel BioCare USA Inc., Yorba Linda, California, by letter and fax on March 29, 2000, and by fax on April 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alaska, Alabama, Arizona, California, Iowa, Massachusetts, Michigan, Minnesota, Oregon, Nebraska, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Virginia, Washington state, Wisconsin, Canada, Chile, Colombia. QUANTITY 77 units were distributed. REASON The spring on the connector to the contra-angle handpiece may fracture and come loose. ________ PRODUCT Accurus 200PS Phacoemusification System, Catalog #8065740742, a phacoemulsification system used for opthalmic surgery featuring phacoemulsification, irrigation and aspiration capability, anterior vitrectomy, and diathermy functions. Recall #Z-780-0. CODE SERIAL NUMBERS: 9901725601X 9902087501X 9901446301X 9901725501X 9901890101X 9901718101X 0001038201X 0001038101X 0001065601X 9901462801X 9901725401X 9901463001X 9901463101X 9901463201X 9901467201X 9901707301X 9901707401X 9901462901X 9901717901X 0001005201X 9901442401X 9901467001X 9901718001X 9902003301X 0001005101X 0001135901X 9901446401X 9901446501X 9901446601X 9901466901X 9901467101X 0001005401X 0001005301X 9901462701X 0001136001X 9801357001X. MANUFACTURER Alcon Laboratories, Inc., Irvine, California. RECALLED BY Alcon Laboratories Inc., also known as Alcon Research LTD, Fort Worth Texas, (responsible firm), by telephone and letter beginning April 25, 2000. Firm-initiated field correction complete. DISTRIBUTION Florida, Maine, New Mexico, Virginia, Vermont, Australia, Germany, Italy, France. QUANTITY 33 units were distributed. REASON The low pressure air output (AVGFI) module used with the Alcon Accurus 200PS may unexpectedly drop to a low setting, resulting in low irrigation or infusion pressure during surgery, while vacuum remains active. ________ PRODUCT Dexter-ZII Blood Glucose Meter, intended for use in self-monitoring of blood glucose by persons with diabetes: a) Model 3958K2; b) Model 3958N2; c) Model 3969N2. Recall #Z-781/783-0. CODE Serial Numbers: 4000114 4000162 4000197 4000330 4001008 4001047 4001072 4001118 4001157 4001178 4001185 4001191 4001199 4001200 4001201 4001215 4001409 4001514 4001833 4002475 4002487 4002569 4002578 4003218 4003303 4003329 4003367 4003443 4003523 4004102 4004110 4004112 4004116 4004129 4004139 4004158 4004264 4004273 4004274 4004278 4004280 4004283 4004284 4004298 4004301 4004303 4004308 4004500 4004502 4004505 4004506 4004511 4004517 4004518 4004521 4004526 4004530 4005010 4005011 4005050 4005068 4005322 4005329 4005359. MANUFACTURER Bayer Corporation, Business Group Diagnostics, Mishawaka, Indiana. RECALLED BY Bayer Corporation, Elkhart, Indiana, by fax on or about April 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Japan. QUANTITY 64 units were distributed. REASON The systems begin to count down prior to the inoculation of the reagent sensor. END OF ENFORCEMENT REPORT FOR JUNE 14, 2000.####
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