April 5, 2000 00-14RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Rosa Maria Bakery brand Italian Cookies (with sprinkles), packaged in 16-ounce rigid plastic containers. Recall #F-223-0. CODE None. MANUFACTURER 96 Vreeland Street Corporation, doing business as Rosa Maria Bakery, Staten Island, New York. RECALLED BY Manufacturer, by visit on August 3, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey. QUANTITY Approximately 200 pounds were distributed. REASON Product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 3, and FD&C Blue No. 1. ________ PRODUCT Bedessee's Marque West Indian Queen(r) brand Kola Champagne des Kolas, in 7-ounce bottles. Recall #F-224-0. CODE None. MANUFACTURER Good-O Beverages, Inc., Bronx, New York. RECALLED BY Bedessee's Imports, Inc., Brooklyn, New York, by letter March 11, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and Canada. QUANTITY 156 cases (40 bottles per case) were distributed. REASON The product contains undeclared FD&C Yellow No. 5 and FD&C Red No. 40. ________ PRODUCT Assorted Fancy Cookies (with sprinkles), packaged in 12-ounce rigid plastic containers. Recall #F-225-0. CODE None. MANUFACTURER Weiss Kosher Bakery, Inc., doing business as Weiss Home Made Kosher Bakery, Brooklyn, New York. RECALLED BY Manufacturer, by letter faxed on March 15, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY 44 packages were distributed. REASON Product contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 3, FD&C Red No. 40, and FD&C Blue No. 1. ________ PRODUCT Shredded Lettuce, in 4-pound plastic bags. Recall #F-228-0. CODE 29929 P/O MAR 10 U/T MAR 19 GSCC XX. MANUFACTURER Club Chef, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by telephone on March 15 and 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Kentucky, Ohio, Maryland, Pennsylvania, Indiana, West Virginia, New York. QUANTITY 562 cases (6 bags per case) were distributed. REASON Product may contain pieces of glass. ________ PRODUCT Spinach Noodle, packaged in 16-ounce plastic bags. Recall #F-229-0. CODE None. MANUFACTURER Twin Marquis, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter on July 27, 1999, followed by telephone. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 1,500 16-ounce packages were distributed. REASON Product contained undeclared FD&C Yellow No. 5 and FD&C Blue No. 1. ________ PRODUCT Dried Ginger, packaged in 3.5-ounce flexible plastic bags. Recall #F-230-0. CODE None. MANUFACTURER Reignever, Ltd., Hong Kong. RECALLED BY YBL World Wide Trading, Inc., Brooklyn, New York (importer), by telephone on February 22, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 51 cases (100 packages per case) were distributed; firm estimates none remains on the market. REASON Product contained the unapproved color additive, Ponceau 4R.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT a) Flaky Nut Rugelech, packaged in 12-ounce rigid plastic containers; b) Lace Cookies, packaged in 12-ounce rigid plastic containers. Recall #F-226/227-0. CODE None. MANUFACTURER Weiss Kosher Bakery, Inc., doing business as Weiss Home Made Kosher Bakery, Brooklyn, New York. RECALLED BY Manufacturer, by letter faxed on March 15, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION a) New Jersey and Pennsylvania; b) Undetermined. QUANTITY a) 50 packages; b) 6 packages were distributed. REASON The label states that the product contains "ground nuts" but does not specify the type of nut(s) in the product.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Rapid Clear Eye Wash, in 16-fluid ounce bottles, Rx for flushing or irrigating the eye. Recall. #D-254-0. CODE Item #90329, Lot #1006 EXP 01/02. MANUFACTURER H.L. Burton Company, Inc., Buzzards Bay, Massachusetts. RECALLED BY Manufacturer, by telephone on March 6, 2000, followed by letter dated March 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Illinois. QUANTITY 206 bottles were distributed. REASON Misbranding - Product contains undeclared preservative-chlorhexidine gluconate. ________ PRODUCT Oxygen, USP, compressed, in E and D cylinders. Recall #D-258-0. CODE Lot Numbers: 102999A and 100899B. MANUFACTURER Family Healthcare Supply, Inc., Sarasota, Florida. RECALLED BY Manufacturer, by visit on December 7, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 4 tanks. REASON Good manufacturing deviations - Including but not limited to purity and strength testing.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Cafergot(r) Suppositories (ergotamine tartrate USP .2mg/caffeine USP 100 mg), Rx indicated as therapy to abort or prevent vascular headache. NDC #0078-0033-02. Recall #D-255-0. CODE Lot #130B9188 EXP 4/01. MANUFACTURER Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. RECALLED BY Manufacturer, by fax and mail on February 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,942 cartons (12 blister packs per carton) were distributed; firm estimated that 5% or less remained on market at time of recall initiation. REASON Subpotency - Ergotamine at 6-month stability testing. ________ PRODUCT Calcium Gluconate Injection, USP, 10%, in 50-mL single dose and in 200-mL pharmacy bulk packages, under the following labels: Fujisawa - NDC #0469-0311-50 and 0469-0311-63; APP - NDC #63323-311-63. Recall #D-257-0. CODE Lot Numbers: 180156, 180180, 180232, 180274, 180170, 180265, 180458, 180538, 180657, 190441, 190629, 190736, 190836. MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois. RECALLED BY Manufacturer, by letter dated March 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Uruguay, Hong Kong, Israel, Singapore. QUANTITY 106,875 50-mL vials and 77,000 200-mL vials were distributed; firm estimated that 25% of the product remained on market at time of recall initiation. REASON Particulate matter in some vials. ________ PRODUCT Diltiazem Hydrochloride Tablets, USP, in 60 mg bottles of 100 and 500, Rx indicated for the management of chronic stable angina and angina due to coronary artery spasm. Recall #D-256-0. CODE Lot #662F01 EXP 5/00. MANUFACTURER Copley Pharmaceutical, Inc., Canton, Massachusetts. RECALLED BY Manufacturer, by letter on March 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,576 100-tablet bottles and 903 500-tablet bottles were distributed. REASON Dissolution failure (stability).RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Tomoscan SR4000, for use in CT radiology. Recall #Z-423-0. CODE None. MANUFACTURER Philips Medical Systems, Shelton, Connecticut. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on March 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 15 units were distributed. REASON Units are defective under 21 CFR 1003.2 in that the defect occurs when the image is reversed in the unitís data bank. This defect then causes the image to be reversed left to right upon retrieval. ________ PRODUCT Tomoscan M/EG CT Scanner with Phase I-Table Controllers and Phase-II Table Controllers, for use in CT radiology. Recall #Z-424/425-0. CODE None. MANUFACTURER Analogic Corporatioin, Peabody, Massachusetts. RECALLED BY Philips Medical Systems, Shelton, Connecticut. FDA approved the firm's corrective action plan on March 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and International. QUANTITY 44 units were distributed. REASON Units are defective under 21 CFR 1003.2 in that they do not interrupt the exposure when the tabletop movement stops during a volume scan mode. This can result in the patient receiving excess exposure at a particular scan plane. ________ PRODUCT ENDO Cannulated Bone or Interference Screw, 7.0 mm x 20 mm. Recall #Z-471-0. CODE Catalog #101-720, Lot #5C32M. MANUFACTURER ENDO Surgical Concepts, Inc., Greenwich, Connecticut. RECALLED BY Manufacturer, by letter on March 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arkansas and Pennsylvania. QUANTITY 95 units. REASON Device may not be sterile. ________ PRODUCT ITI O.4.8mm Esthetic Plus Solid Screw implant ITI Dental Implants are intended for surgical placement in the maxillary and/or manibular arches to provide support for crowns, bridges, or overdentures in edentulous or partially edentulous patients. Recall #Z-472-0. CODE Article No.: 043.240S Lot Number: 1002 Expiration: JULY 2004. MANUFACTURER Institut Straumann AG, Waldenburg, Switzerland. RECALLED BY The Straumann Company, Waltham, Massachusetts, by letter dated March 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 138 units. REASON Mislabeled - Package incorrectly states diameter as 4.1mm vs 4.8mm diameter. ________ PRODUCT I-125 Seeds, therapeutic for interstitial brachytherapy, Model 6711. Recall #Z-473-0. CODE Sales Order 173539 containing sublots E5306A, E5358A, 91260A. MANUFACTURER Medi-Physics, Inc., doing business as Nycomed Amersham Imaging, Arlington Heights, Illinois. RECALLED BY Manufacturer, by requesting hospital to return the seeds in question on January 5, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 111 seeds were distributed. REASON Seeds have a higher radioactivity than stated on the label. ________ PRODUCT Theraport Vascular Access System, Model 1001, 1002, 1601, 1602. Recall #Z-474/477-0. CODE Lot Numbers: 9611081 and 9611121. MANUFACTURER Biocontrol Technology, Inc., Indiana, Pennsylvania. RECALLED BY Manufacturer, by, letter on March 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Pennsylvania, Virginia, Turkey. QUANTITY 197 units were distributed. REASON Possible leakage of the portal assembly due to cracks in the outlet tube-to-port weld. ________ PRODUCT Allograft Heart Valve, Model AVOO. Recall #Z-478-0. CODE Serial #3999297. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by telephone on March 9, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 valve. REASON Donor did not meet current guidelines regarding serodilution of plasma.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Sterile 3.5mm x 27.5mm Cortical Screw. Recall #Z-479-0. CODE Part #CO-3275, Lot #2682-AG. MANUFACTURER Acumed, Inc., Beaverton, Oregon. RECALLED BY Manufacturer, by fax on February 29, 2000, followed by telephone on March 1 and 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida and the United Kingdom. QUANTITY 14 units were distributed. REASON Package labeling on the sterile version of this part incorrectly states that the cortical screw belongs to the Polarus Humeral Fixation System family. This device is intended to be used with IM Rod System. ________ PRODUCT Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0. CODE List #4E43-03, distributed between 2/8/00 and 2/12/00. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. Vendor, Media Magnetics, Richardson, Texas (the firm that duplicated the disks). RECALLED BY Abbott Laboratories, Inc., Irving, Texas, by telephone on February 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Brazil. QUANTITY 97 units were distributed. REASON The disks are improperly duplicated and contain software that will install System International (SI) units, rather than conventional units as labeled. ________ PRODUCT Aeroset Analyzer, used for in-vitro diagnostic tests. Recall #Z-489-0. CODE All Codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 176 analyzers were distributed. REASON Under certain washing conditions, software error causes erratic urine creatinine results.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
________ PRODUCT 100% Natural Chew Pig Ears, dog chews packaged in flexible plastic bags as singles, 2-packs, and 8-packs. Recall #V-066-0. CODE None. MANUFACTURER Warren Pet Products, Kewanee, Illinois (repacker). RECALLED BY Repacker, by telephone on December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa, Kansas, Indiana, Tennessee, Florida, Georgia, Texas, Missouri, Michigan, New York, Virginia, North Carolina, Illinois, Arizona, Pennsylvania, Minnesota. South Carolina QUANTITY 70,169 singles, 9,288 2-packs, and 9,489 8-packs were distributed between 1/1/99 and 12/8/99. REASON Pet chews had the possibility of being positive for Salmonella Ohio. ________ PRODUCT Medium/Large Smoked Pig Ears and Medium Large Natural Pig Ears in bulk cardboard boxes. Recall #V-069-0. CODE Not Coded. All product shipped/received after 7/21/99 through 12/12/99. MANUFACTURER Gol-Can, SA, Lara, Venezuela. RECALLED BY S.A.S. Imports, Ft. Pierce, Florida, by letter dated January 11, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION North Carolina, South Carolina, Florida, Wisconsin, Virginia, Georgia, Alabama, Kansas, California. QUANTITY 52,015 Medium/Large natural and smoked pig ears were distributed. REASON Pet chews had the possibility of being positive for Salmonella Ohio. ________ PRODUCT Dog treats containing beef trachea: a) Uncle Sam's Chew-N-Moo, 2 pieces/retail package (UPC #0-73091-81618-8), 12/2-piece packages/case (Item #81618, UPC #100-73091-81618-5). b) Uncle Sam's Value Pack Steer-N-Chew, 7 pieces/retail package (UPC #0-73091-81623-2), 12/7-piece packages per case (Item #81623, UPC #100-73091-81623-9). c) Uncle Sam's Steer-N-Chew Value Pack Holiday Gift, 7 pieces/retail package (UPC #0-73091-81623-2), 12/7-piece packages/case (Item #81623, UPC #100-73091-81623-). d) Uncle Sam's Value Pack Steer-N-Hog Chew, 8 pieces/retail package, UPC #0-73091-81624-9), 12/8-piece packages/case (Item #81624, UPC #100-73091-81624-6). e) Uncle Sam's Steer-N-Hog Chew Value Pack Holiday Gift, 8 pieces/retail package (UPC #0-73091-81624-9), 12/8-piece packages/case (Item #81624, UPC #100-73091-81624-6). f) Old West Beef Trachea packaged in 60-ct. hex jars, Item #81918. (This product is sold in retail stores by the piece and the jar is displayed with 7 other varieties of dog treats in separate jars). Recall #V-070/075-0. CODE None. All products produced since June 1, 1999. MANUFACTURER Treatco, Inc., Wichita, Kansas. RECALLED BY Sergeant's Pet Products, Inc., Omaha, Nebraska, by letter dated December 28, 1999, and by press release on December 29, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 1,461 cases were distributed. REASON Products may be contaminated with Salmonella.MEDICAL DEVICE SAFETY ALERTS
________ PRODUCT AngioJet Thrombectomy System: a) AngioJet Rheolytic Thrombectomy Catheters, Model Nos. AV60, CF105, F110; b) AngioJet Rheolytic Thrombectomy Catheter, Model No. LF140. Safety Alert #N-006/007-0. CODE All lots. MANUFACTURER Possis Medical, Inc., Minneapolis, Minnesota. ALERTED BY Manufacturer, by letter dated February 28, 2000. DISTRIBUTION Nationwide. QUANTITY 14,084 units were distributed. REASON A problem can occur when the outflow lumen is used to inject dye or other material. ________ PRODUCT PSN-120, PSN 140, PSN-130, PSN-150, PSN-170, PSN-210 Polysynthane Hemodialyzers; a sterile, single use blood path for hemodialysis of patients with acute or chronic renal failure when conservative therapy is judged to be inadequate or the patients are intoxicated with poisons or drugs. Safety Alert #N-008/013-0. CODE All units of product codes 5M1814, PSN-120, 1.2 m2 surface area x 210 mm length 5M1815, PSN-140, 1.4 m2 surface area x 210 mm length R5M4233, PSN-130, 1.3 m2 surface area x 229 mm length R5M4234, PSN-150, 1.5 m2 surface area x 229 mm length R5M4235, PSN-170, 1.7 m2 surface area x 229 mm length R5M4236, PSN-210, 2.1 m2 surface area x 229 mm length. MANUFACTURER Baxter Healthcare Corporation, Mountain Home Arkansas. ALERTED BY Baxter Healthcare Corporation, McGaw Park, Illinois. by letter dated February 17, 2000. DISTRIBUTION Nationwide and International. QUANTITY Approximately 2,387,736 units. REASON Patients may experience hypersensitivity (allergic) reactions during dialysis with the first exposure to the PSN dialyzer. END OF ENFORCEMENT REPORT FOR APRIL 5, 2000.####
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