February 14, 2001 01-06RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: Daily-Vite Daily Multiple Vitamin Formula. Recall #F-206-1. CODE: All lots on the market at the time the recall was initiated. MANUFACTURER: Pharmaceutical Corporation of America, Carmel, IN. RECALLED BY: Manufacturer, by letter on March 13, 2000. Firm-initiated recall complete. DISTRIBUTION: United States. QUANTITY: Unknown. REASON: The product was manufactured under conditions whereby it may have been contaminated with beta-lactam antibiotic drug residues from other products repackaged at the same facility.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Redbug Brand, dried shrimp in 1 LB. packages. Recall #F-197-1. CODE: None. MANUFACTURER: Blum & Bergeron Inc., Houma, LA RECALLED BY: ASIA Trans & Co., Inc., Kailua-Kona, HI via telephone on 1/02/01. FDA- initiated recall ongoing.. DISTRIBUTION: Hawaii. QUANTITY: 100 LBS. REASON: The product contains undeclared FD&C Red No. 40. ________ PRODUCT: Coca-Cola Classic, 2 liter plastic bottles. Recall #F-207-1. CODE: JAN2201JAA, JAN2202JAD and JAN2201JAE. MANUFACTURER: Coca Cola Bottling Co., Jacksonville Plant aka Coca-Cola Enterprises Bottler, Jacksonville, FL. RECALLED BY: Manufacturer by faxed memo on 10/30/00. Firm-initiated recall complete. DISTRIBUTION: Florida and Georgia. QUANTITY: 25,190 cases, 12 per case. REASON: The product was manufactured under insanitary conditions whereby it may have become contaminated with filth. ________ PRODUCT: Recall #F-208-1. #3459 - Henry & Henry brand - STRING ICING, Net Wt. 45 lbs., Responsible firm on the label: "Manufactured by Henry & Henry, Inc., Lancaster, NY 14086". Recall #F-209-1. #3456 - Henry & Henry brand WHITE ROLL ICIN' - a ready- to-use stabilized icing for donuts, danish and sweet goods. Net Wt. 45 lbs. Responsible firm on label: Henry & Henry, Inc., Lancaster, NY. Recall #F-210-1. #11903-2 - Westco brand WHITE ROLL ICING - a ready-to- use icing for donuts, danish and sweet goods, Net. Wt. 25 lbs. Responsible firm on the label: Distributed by WESTCO PRODUCTS, Inc., Pico Rivera, CA. Recall #F-211-1. #3451 - Henry & Henry Imperial White Creme Icing, a fully prepared vanilla flavored buttercreme style icing for cakes and donuts, Net Weight 30 lbs. Responsible firm on label: Henry & Henry, Inc., Lancaster, NY 14086. Recall #F-212-1. #3452 - Henry & Henry Imperial Chocolate Creme Icing, a fully prepared chocolate flavored buttercreme style icing for cakes and donuts, net weight 30 lbs. Responsible firm on label: Henry & Henry, Lancaster, NY. Recall #F-213-1. #3457 - Henry & Henry Top-Kote Chocolate Enrobing Icing, a fully prepared coating containing chocolate, net weight 20 lbs. Responsible firm on label: Henry & Henry, Lancaster, NY. Recall #F-214-1. #11900-8 - BakeMark Vanilla Buttercreme Icing, ready to use, artificially flavored, Net Weight 30 lbs. Responsible firm on label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-215-1. #11901-6 - BakeMark Chocolate Buttercreme Icing, ready to use, Net Weight 30 lbs. Responsible firm on label: BakeMark, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-216-1. #3247 - Henry & Henry - Cream Cheese Roll Icing, Net Weight 20 lb. Responsible firm on label: Henry & Henry, Lancaster, NY. Recall #F-217-1. #3458 - Henry & Henry Ready-to-Use Cream Cheese Icing, Net Weight 20 lbs. Responsible firm on label: Henry & Henry, Lancaster, NY. Recall #F-218-1. #3469 - Henry & Henry - Caramel Artificially Flavored Fudge Icing, Net Weight 55lbs. Responsible firm on label: Henry & Henry, Lancaster, NY. Recall #F-219-1. #3472 - Henry & Henry - Easy Dip Vanilla Artificially Flavored Icing, fully prepared ready-to-use dipping icing, Net Weight 23 lbs.. Also sold in 45 lb. containers using the same label with different Net Weight statement. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-220-1. #3473 - Henry & Henry - Easy Dip Chocolate Artificially Flavored Icing, fully prepared ready-to-use dipping icing, Net Weight 23 lbs.. Also sold in 45 lb. containers using the same label with a different Net Weight statement. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-221-1. #3474 - Henry & Henry - Easy Dip Caramel Artificially Flavored Icing, a fully prepared ready-to-use dipping icing, Net Weight 23 lbs. Also sold in 45 lb. containers using the same label with a different Net Weight statement. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-222-1. #3528 - Henry & Henry Redi-Pak Roll Icin', made with fondant, a ready-to-use stablized icing for donuts, danish and sweet goods, Net Weight 24 lbs. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-223-1. #3529 - Henry & Henry Redi-Pak Cream Cheese Roll Icing, Net Weight 24 lbs. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-224-1. #3949 - Henry & Henry - Star Glaze, a fully prepared donut glaze, Net weight 40 lbs. Responsible firm on the label: Henry & Henry, Lancaster, NY. Recall #F-225-1. #36621-1 - BakeMark White Roll Icing, Net Weight 25 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-226-1. #36546-0 - BakeMark String Icing, Net Weight 25 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-227-1. #36521-3 - BakeMark Ready to Use Ready Dip Vanilla Icing, Artificially Flavored, Net Weight 23 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-228-1. #36526-2 - BakeMark Ready to Use Ready Dip Chocolate Icing, Net Weight 23 lbs. BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-229-1. #36531-2 - BakeMark Ready to Use Ready Dip Maple Icing, Artificially Flavored, Net Weight 23 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-230-1. #36536-1 - BakeMark Ready to Use Ready Dip Caramel Icing, Net Weight 23 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. Recall #F-231-1. #11864-6 - BakeMark Ready to Use Cream Cheese Icing, Net Weight 20 lbs. Responsible firm on the label: BakeMark Ingredients, Schaumburg, IL, Los Angeles, CA and Richmond, B.C. CODE: All lots produced up to 10/26/2000 are affected. Product is coded with a 4 digit date code. The first digit is the year. The following 3 digits are the Julian date. All production after 10/26/2000 (coded 0300) should be properly labeled. MANUFACTURER: Henry & Henry, Inc., Lancaster, NY. RECALLED BY: Manufacturer, by letters on 10/10/2000 and a second letter on 10/26/2000 to include 21 additional products. Completed recall resulted from follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: Nationwide and Canada. QUANTITY: 32,207 units (various weights/sizes). REASON: The products contain undeclared wheat starch.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
__________ PRODUCTS: a) Red Blood Cells. Recall #B-388-1; b) Recovered Plasma. Recall #B- 389-1 CODE: a) Unit 23140-5067; b) Unit 23140-5067 MANUFACTURER: United Blood Services, Billings, MT RECALLED BY: Blood Systems, Inc. Scottsdale, AZ by telephone on October 23, 2000 and by letter dated November 3, 2000. Firm-initiated recall complete. DISTRIBUTION: Montana. QUANTITY: Two units. REASON: Blood products, collected in a manner that compromised the sterility of the units, were distributed. _________ PRODUCT: Red Blood Cells, Leukocyte Reduced. Recall #B-435-1. CODE: Unit 612942. MANUFACTURER: Blood Centers of the Pacific, Peninsula South Bay Center, Burlingame, CA. RECALLED BY: Blood Centers of the Pacific, Irwin Center, San Francisco, CA. by letter dated October 20, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, which was collected from a donor who traveled to a malaria endemic area, was distributed. _________ PRODUCT: Source Plasma. Recall #B-439-1. CODE: Units 98AIAB5307; 98AIAB5536; 98AIAB5895; 98AIAB5957. MANUFACTURER: Community Bio-Resources, Inc., Ames, IA. RECALLED BY: Manufacturer, by facsimile dated January 4, 1999. Firm-initiated recall complete. DISTRIBUTION: Austria QUANTITY: Four units. REASON: Blood products, collected from a donor whose partner had tested positive for Hepatitis B, were distributed. _________ PRODUCT: Platelet, Pheresis. Recall #B-450-1. CODE: Unit 09P63386. MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer, by telephone on December 30, 1997. Firm-initiated recall complete. DISTRIBUTION: Nebraska QUANTITY: One unit. REASON: Blood product, mislabeled as CMV antibody negative was shipped. _________ PRODUCT: a)Red Blood Cells, Recall #B-455-1; b) Platelets, Recall #B-456-1; c) Recovered Plasma. Recall #B-457-1. CODE: a) Units 18S42122 and 18R53862; b) unit 18R53862; c) units 18S42122 and 18R53862. MANUFACTURER: American Red Cross, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letters dated April 2 and 3, 1998. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Five units. REASON: Blood products, which were collected from a donor who had close contact with an individual with hepatitis, were distributed. _________ PRODUCT: a)Red Blood Cells, Recall #B-458-1; b) Platelets, Recall #B-459-1; c) Fresh Frozen Plasma. Recall #B-460-1. CODE: a) Unit 3443670; b) unit 3443670; c) units 3443670. MANUFACTURER: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI. RECALLED BY: Manufacturer, by letter dated December l0, 1999. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Three units. REASON: Blood products, which were collected from a donor who had a history of jaundice, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-461-1; b) Platelets, Recall #B-462-1; c) Cryoprecipitated AHF. Recall #B-463-1; d) Recovered Plasma. Recall #B- 464-1. CODE: a) Units 6240871 and 6238468; b) unit 6240871; c) unit 6238468; d) units 6240871 and 6238468. MANUFACTURER: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI. RECALLED BY: Manufacturer, by letter dated December l0, 1999. Firm-initiated recall complete. DISTRIBUTION: Michigan, Texas, and Switzerland. QUANTITY: Six units. REASON: Blood products, which were collected from a donor who had a history of jaundice, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-465-1; b)Fresh Frozen Plasma. Recall #B-466- 1. CODE: a) Unit 8120965; b) unit 8120965. MANUFACTURER: Michigan Community Blood Centers, Traverse City, MI. RECALLED BY: Manufacturer, by letter dated September l4, 1998. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Two units. REASON: Blood products, which were collected from a donor who had a history of jaundice, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-467-1; b) Platelets, Recall #B-468-1; c) Recovered Plasma. Recall #B-469-1. CODE: a) Unit 27V70270; b) unit 27V70270; c) units 27V70270. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letter dated July l9, 1999. Firm-initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: Three units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-470-1; b)Recovered Plasma. Recall #B-471-1. CODE: a) Units 27FC81229, 27Y66597; b) units 27FC81229, 27Y66597. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letter dated February l6, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania and Virginia. QUANTITY: Four units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis C, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-472-1; b) Fresh Frozen Plasma. Recall #B- 473-1. CODE: a) Unit 27GJ13845; b) unit 27GJ13845. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letter dated February 8, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Two units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-474-1; b) Platelets, Recall #B-475-1; c)Fresh Frozen Plasma. Recall #B-476-1; d) Recovered Plasma. Recall #B- 477-1. CODE: a) Units 27GX00670, 27GW05537, 27GV42240; b) unit 27GV42240; c) units 27GV42240; d) units 27GX00670, 27GW05537. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letter dated May l0, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania and West Virginia. QUANTITY: Seven units. REASON: Blood products, collected from a donor who provided post donation information regarding high risk behaviors, and a positive test for Hepatitis B, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-478-1; b) Recovered Plasma. Recall #B-479-1. CODE: a) Unit 27W82103; b) units 27W82103, 27GK00294. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letters dated May 26, 1999 June 29, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Three units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-480-1; b) Recovered Plasma. Recall #B-481-1. CODE: a) Unit 27GM22886, 27GX05539; b) unit 27GM22886, 27GX05539. MANUFACTURER: American Red Cross Blood Services, Johnstown Region, Johnstown, PA.. RECALLED BY: Manufacturer, by letter on March 10, 2000. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Four units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-486-1; b) Platelets, Recall #B-487-1; c) Fresh Frozen Plasma. Recall #B-488-1; Frozen Plasma. Recall #B-489-1. CODE: a) Units 42FS55887, 42H19005, 42W11875; b) units 42FS55887,42H19005; c) units 42FS55887, 42H19005; d) unit 42W11875. MANUFACTURER: American Red Cross Blood Services, Northern Ohio Region, Cleveland , OH. RECALLED BY: Manufacturer, by letter dated August 8, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Eight units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis B core antigen (anti-HBc), were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-490-1; b)Recovered Plasma. Recall #B-491-1. CODE: a) Unit 04C25250; b)unit 04C25250. MANUFACTURER: American Red Cross, New England Region, Dedham, MA. RECALLED BY: Manufacturer, by telephone on May 24, 2000. And by letter dated June 5, 2000. Firm-initiated recall complete. DISTRIBUTION: New Hampshire. QUANTITY: Two units. REASON: Blood products, collected from a donor living with a father who had been diagnosed with hepatitis, were distributed. ________ PRODUCT: a)Red Blood Cells, Recall #B-492-1; b) Recovered Plasma. Recall #B-493-1. CODE: a) Unit 09GN72421; b) unit 09GN72421. MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer, by letters dated March 27 & 30, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: Two units. REASON: Blood products, which tested negative for all required viral marker tests, but were collected from a donor who had previously tested positive for Hepatitis due to mononucleosis, were distributed. ________ PRODUCT: Platelets, Recall #B-498-1. CODE: Unit 1696296. MANUFACTURER: Central Kentucky Blood Center, Lexington, KY. RECALLED BY: Manufacturer, by letter dated October 24, 2000. Firm-initiated recall complete. DISTRIBUTION: Kentucky. QUANTITY: One unit. REASON: Blood producd, collected from a donor who had taken aspirin within 36 hours of donation, was distributed. ________ PRODUCT: Source Plasma. Recall #B-501-1. CODE: Unit 98AIAB4447. MANUFACTURER: Community Bio-Resources, Inc., Ames, IA. RECALLED BY: Manufacturer, by facsimile dated January l1, 1999. Firm-initiated recall complete. DISTRIBUTION: Austria. QUANTITY: One units. REASON: Blood products, collected from a donor who had been immunized with MMR vaccine, within four weeks of the donations, were distributed. ________ PRODUCT: Source Plasma. Recall #B-502-1. CODE: Units 98AIAB3376, 98AIAB3604, 98AIAB4021. MANUFACTURER: Community Bio-Resources, Inc., Ames, IA. RECALLED BY: Manufacturer, by facsimile dated December 3, 1998. Firm-initiated recall complete. DISTRIBUTION: Austria. QUANTITY: Three units. REASON: Blood products, collected from a donor who had been immunized with MMR vaccine, within four weeks of the donations, were distributed. ________ PRODUCT: Source Plasma for manufacture only into in vitro diagnostic reagents for which there are not alternative sources. Recall #B-515-1. CODE: Unit LO067455. MANUFACTURER: Sera-Tec Biological Limited Partnership, Loraine, OH. RECALLED BY: Manufacturer, by facsimile dated May 30, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, which tested RIBA anti-HCV positive, was distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-518-1. b) Red Blood Cells, Irradiated. Recall #B-519-1. CODE: a) Units 27J51089, 27J51092, and 27J51090; b) unit 27J51095. MANUFACTURER: The American National Red Cross, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by letter dated February 2, 1998. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: Four units. REASON: Blood products, incorrectly tested for syphilis, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-520-1. CODE: Unit 27J14201. MANUFACTURER: The American National Red Cross, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by letter dated April 23, 1999. Firm-initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: One unit. REASON: Blood product, manufactured from an overweight unit of Whole Blood, was distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-521-1; b) Platelets. Recall #B-522-1; c) Fresh Frozen Plasma. Recall #B-523-1. CODE: a)Unit 0485059; b) pool number 0071372 (pool included single donor unit 0485059); c) unit 0485059. MANUFACTURER: Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH. RECALLED BY: Manufacturer, by letters dated March 8, 2000 and June 5, 2000. Firm- initiated recall complete. DISTRIBUTION: Ohio and Kentucky. QUANTITY: Three units. REASON: Blood products, collected from a donor who should have been deferred based on a reported blood/body fluid exposure, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-524-1. CODE: Unit 27GS20999. MANUFACTURER: The American National Red Cross, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by telephone on June 22, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: One unit. REASON: Blood products, untested for Cytomegalovirus (CMV), but labeled as CMV negative, was distributed. ________ PRODUCT: Source Plasma. Recall #B-527-1. CODE: Units G-68267-099, G-65613-099, G-65277-099, G-64846-099, G-29146-099, G-28935-099, G-30131-099, and G-29970-099. MANUFACTURER: Alpha Therapeutic Corporation, Sacramento, CA. RECALLED BY: Manufacturer, by letter dated January 5, 2000. Firm-initiated recall complete. DISTRIBUTION: Tennessee, Italy, Spain, and Germany. QUANTITY: Eight units. REASON: Blood products, that tested negative for viral markers, but were collected from an unsuitable donor tbased on previous reactive viral marker testing, were distributed. ________ PRODUCT: Platelet, Pheresis, Leukocytes Reduced. Recall #B-528-1. CODE: Unit 12W40418. MANUFACTURER: American National Red Cross Services, The Carolina Region, Charlotte, NC. RECALLED BY: Manufacturer, by telephone on January 28, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, with elevated platelet count, was distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Electromyography (EMG) Monitor, Nerve Locator/Stimulator, Model No. 302L A3000, Recall #Z-149-1; Model No. 302P A3000, Recall #Z- 150-1. CODE: 9910-1000 9909-1001 9910-1002 9910-1005 9910-1006 9910-1007 9911-1008 9911-1009 9911-1011 9912-1012 9912-1013 0001-1014 0003-1015 FJ960184 120 132 134 137 142 144 166 MANUFACTURER: Neurosoft, Inc., El Paso, TX. RECALLED BY: Manufacturer by letter on October 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Missouri, New York, California, South Carolina, Texas, Ohio, Maryland, Minnesota, North Carolina, Canada, Egypt, and the United Kingdom. QUANTITY: 21 REASON: The device violates the safety standard 601-1 identified in the premarket approval. ________ PRODUCT: Electromyography (EMG) Monitor, Nerve Locator/Stimulator Patient Interface for Model Nos. NIM2 and NIM2XL. Recall #Z-151-1 CODE: 82-20201. MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL. RECALLED BY: Manufacturer, by letter on August 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Hong Kong, Turkey, Singapore, Switzerland, Israel, Sweden, Ireland, Taiwan-Republic of China, Australia, France, Germany, Ontario- Canada, England and Osaka, Japan. QUANTITY: 271. REASON: The device may fail to indicate the existence of a nerve and result in permanent nerve damage from surgery, which would have a serious impact on the patient. The device defect presents a moderate risk of severe adverse health consequences. ________ PRODUCT: Ohmeda Medical Two Mode Continuous Vacuum Regulators: Recall #Z-195-1, Model 67xx1225-9xx - 2 Mode Standard Clockwise Domestic; Recall #Z-196-1, Model 67xx1227-9xx - 2 Mode Low Clockwise Domestic; Recall #Z-197-1 Model 67xx-1330-9xx - 2 Mode High Clockwise Domestic; Recall #Z-198-1, Model 67xx-1230-9xx - 2 Mode High Counter-clockwise International; Recall #Z-199-1, Model 67xx-1233-9xx - 2 Mode Low Counter- clockwise International. CODE: Serial Nos. GFHD 004234-GFHD 053409. MANUFACTURER: Aeros Instruments, Inc., Gurnee, IL. RECALLED BY: Manufacturer by letter on October 4, 2000. A follow-up corrected recall letter was sent to the direct accounts on October 10, 2000. Firm- initiated recall ongoing. DISTRIBUTION: 52 hospitals nationwide, and 18 distributors in Saudi Arabia, Thailand, Kuwait, Canada, Germany, United Kingdom, Australia, Spain, Italy, Honduras, Hong Kong, Belgium, Japan, Malaysia, Ireland and Mexico. QUANTITY: 818 units. REASON: Continuous vacuum regulator is mislabeled. ________ PRODUCT: TheraSeed Palladium 103 (Pd-103) Seeds. Recall #Z-200-1. CODE: Lots RP06N041A and RM02N008Q. MANUFACTURER: Theragenics Corporation, Norcross, GA. RECALLED BY: Manufacturer by FAX and telephone on June 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION: CO, CT, DE, FL, IL, IN, MA, OH, TN, WA, WV, WI. QUANTITY: 12. REASON: Substandard spacers may lead to difficulty during preparation and delivery of radiation therapy to the patient. ________ PRODUCT: Z-225-1 - Neoprene Knee Support with Ova Pad; Z-226-1 - Perforated Knee Splint; Z-227-1 - 3"Elastic Ankle Wrap; Z-228-1 - Universal Pelvic Traction Belt; Z-229-1 - Universal Abdominal Binder, 9"; Z-230-1 - Universal Rib Belt; Z-231-1 - 6" Rib Belt; Z-232-1 - Clavicle Strap II; Z-233-1 - Clavicle Strap - Self Adjusting; Z-234-1 - Tennis Elbow Strap; Z-235-1 - Universal Ambidextrous Wristlet; CODE: All codes for products manufactured from 9/30/98 and 12/4/00 MANUFACTURER: DeRoyal Industries, Inc., Powell, TN. RECALLED BY: Manufacturer by letter on December 12 and 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. Austria, Ireland, United Kingdom, Portugal, Costa Rica, Sweden, El Salvador, Netherlands, Honduras, Saudi Arabia, Chile, Nairobe, Switzerland, Japan and New Zealand. 17 Canadian firms and 74 US government/military accounts. QUANTITY: 402,742. REASON: Undeclared natural rubber in the products.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: High Temperature Power Handle. Catalog No. HIT1. Recall #Z-220-1 CODE: All codes distributed 3/1/2000 to 7/1/2000. MANUFACTURER: Aaron Medical Industries, St. Peterburg, FL. RECALLED BY: Manufacturer, by letter on July 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, and France, Finland, Canada, and Denmark. QUANTITY: 125. REASON: The descriptive labeling imprinted on the body of the device identifies it incorrectly as a "low temperature Power Handle." The labeling of the device on the outer box correctly identifies the device as a "High Temperature Power Handle." ________ PRODUCT: Cellpack-GL, Catalog No. PGL-300A. RECALL #Z-221-1. CODE: PGL-300A. MANUFACTURER: Sysmex Reagents America, Inc., Los Alamitos, CA RECALLED BY: Manufacturer by letter on December 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 918 - 20 Liter containers. REASON: Reagent design deficiency provides too many false positive results. ________ PRODUCT: Tenure Dental Adhesive (DML-32). Recall #Z-222-1. CODE: Lot No. 461156; MANUFACTURER: Den-Mat Corp., Santa Maria, CA. RECALLED BY: Manufacturer by letter on June 1, 2000. Firm-initiated recall complete. DISTRIBUTION: Canada. QUANTITY: 17 units were recalled and destroyed at the distributor. REASON: Dental adhesive lot failed the bond strength test prior to the expiration date of the product. _________ PRODUCT: Virtuoso Flowable Light Cure Composite with Fluoride. Recall #Z-223-1. CODE: Lot No. 407001D, Part No. 030381827. MANUFACTURER: Den-Mat Corp., Santa Maria, CA RECALLED BY: Manufacturer by letter on June 29, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 565 syringes. REASON: Lot failed the bond strength test prior to the expiration date of the product.RECALLS AND FIELD CORRECTIONS: VETERINARY MED -- CLASS III
_________ PRODUCT: Nolvasan Antiseptic Ointment - 1% chlorhexidine acetate - 7-oz. plastic jars and 16-oz. plastic jars - for use as topical antiseptic ointment for dogs, cats, and horses. Recall # V-011-1. CODES: Lot 371479, exp JUN 01 - 7-oz. jars Lot 371480, exp JUN 01 - 16-oz. jars Lot 371481, exp AUG 01 - 16-oz. jars MANUFACTURER: Fort Dodge Animal Health, Fort Dodge, Iowa. RECALLED BY: Manufacturer, via telephone on December 15, 2000. The firm initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 4,777 jars of lot 371479, 2,290 jars of lot 371480, and 2,187 jars of lot 371481. REASON: Product failed stability testing and is subpotent. END OF ENFORCEMENT REPORT FOR FEBRUARY 14, 2001 ####
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