FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


January 24, 2001                                                         01-03


RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT: Dried Potato in 6 oz. Plastic bags. Recall #F-161-1 CODE: None. All product on the market at the time the recall was initiated was affected. MANUFACTURER: Market Group Corp., Guangdong, China. RECALLED BY: YBL World Wide Trading Inc., Brooklyn, NY(importer)by letter dated April 12, 2000 and by New York State Department of Agriculture and Markets' press release issued April 7, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York. QUANTITY: 117 cases (100-6 oz packages per case) were distributed. REASON: Product contains undeclared sulfites. _______ PRODUCT: San Francisco Foods Co. brand Seafood Salad in 5 lb. Plastic buckets. Recall # F-175-1. CODE: Best if used by date "DEC010". MANUFACTURER: Ittella Foods, Inc., Los Angeles, CA RECALLED BY: Manufacturer, by telephone on October 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Washington State, Oregon, Canada. QUANTITY: 1122 cases (2 - 5 lb. Plastic buckets per case. REASON: The product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT: Longevity Noodle in 1 lb. Plastic bags. Recall #F-163-1. CODE: None. All product on the market at the time the recall was initiated was affected. MANUFACTURER: Wang Derm Exporters Ltd. Part., Bangkok, Thailand RECALLED BY: Vasinee Food Corp., Brooklyn, NY (importer), by letter on August 18, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York, Pennsylvania, Rhode Island, Massachusetts. QUANTITY: 200 cases (25-1 lb. Packages per case). REASON: The product contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT: Orange Jelly packages in a rigid plastic cup with a foil seal, net wt. 30 grams. Recall #F-165-1. CODE: Best before 10 09 2000. MANUFACTURER: Xinhui Foodstuffs Imp. & Exp. Company of Guangdong, Xinhui City Guangdong, China. RECALLED BY: Allied Imports, Inc. Brooklyn, NY (importer), by telephone July 28, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York. QUANTITY: 14 cases (11 lbs. of packages per case). REASON: The product did not bear an ingredient statement in English and it contains the uncertified color additives tartrazine (certifiable as FD&C Yellow No.5) and sunset yellow FCF (certifiable as FD&C Yellow No. 6). ________ PRODUCT: Albert's Greek Pepperocini Peppers in 15.5 oz. containers. Recall #F- 166-1. CODE: 573531 MANUFACTURER: A Millner Corp., Bethlehem, PA. RECALLED BY: Manufacturer, by letter on September 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Nebraska. QUANTITY: 100 cases (12 -15.5 oz. Containers per case). REASON: The product contained undeclared FD&C Yellow No. 5. ________ PRODUCT: Ice Milk Mixes. Recall numbers: F-167-1 14% Premium Mix, 2.5 gallons F-168-1 Cone Ice Milk Mix, Chocolate, ½ gallon F-169-1 Shake Ice Milk Mix, Vanilla, ½ gallon F-170-1 Cone Ice Milk Mix, Vanilla ½ gallon CODE: All product distributed prior to August 11, 2000. MANUFACTURER: Sinton’s Dairy Food Company LLC, Colorado Springs, CO. RECALLED BY: Manufacturer, by telephone on August 11, 2000, followed by letter. Firm-initiated recall complete. DISTRIBUTION: Colorado. QUANTITY: 209,773 units. REASON: The products contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. ________ PRODUCT: Hwang Ryh Shiang Fermented Bean Curd Chunk with Sesame Oil in 10.25 oz. glass jars. Recall #F-172-1. CODE: None. All product on the market at the time the recall was initiated was affected. MANUFACTURER: Hwang Ryh Shiang Co., Ltd., Ta His, Taiwan RECALLED BY: Summit Import Corp., New York, NY by letter dated August 1, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York, Pennsylvania, New Jersey, Tennessee, Florida, Virginia, Ohio, North Carolina. QUANTITY: 113 cases (24 jars per case). REASON: The product was produced under insanitary conditions whereby it may have been rendered injurious to health. _______ PRODUCT: Golden Fortune brand Bean Curd Cake in 10.5 oz. Glass jars. Recall #F- 173-1. CODE: None. All product on the market at the time the recall was initiated was affected. MANUFACTURER: Hwang Ryh Shiang Co., Ltd., Ta His, Taiwan. RECALLED BY: Summit Import Corp., New York, NY, by letter dated August 1, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York, New Jersey, Connecticut, Ohio, Maryland, Virginia, Illinois, Florida. QUANTITY: 49 cases (24 jars per case). REASON: Product was produced under insanitary conditions whereby it may have been rendered injurious to health. ________ PRODUCT: Enriched Scott's brand Pearl Plain Yellow Corn Meal in 50 lb. bags. Recall #F-174-1. CODE: Lot 348. MANUFACTURER: Scott’s Auburn Mills, Inc., Auburn, KY. RECALLED BY: Manufacturer, by fax and mail on January 11, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Illinois. QUANTITY: 25-50 lb. bags REASON: The products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________ PRODUCT: Welch’s 100% Orange Juice in 16 fl. oz. Plastic bottles. Recall #F-164-1. CODE: Lot OV26G MANUFACTURER: Krier Foods, Inc., Random Lake, WI RECALLED BY: Welch’s, Concord, MA, by email and fax on October 3, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 3854 cases (24 bottles per case). REASON: The product unfit for food due to mold contamination. ________ PRODUCT: Green Squall flavor POWRADE beverage in 20 oz. Plastic bottles. Recall #F-171-1. CODE: MAY1401MDD MANUFACTURER: The Minute Maid Co. for Coca-Cola USA at Coca-Cola Bottling Co. of Chicago, Niles, IL. RECALLED BY: Coca-Cola USA Operations, Atlanta, GA, by email and fax December 8, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 13,730 cases (24 bottles per case). REASON: Product is unfit for food due to mold contamination.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_________ PRODUCT: a)Allergenic Extract Hormodendrum cladosporioides, b)Allergenic Extract Aspergillus niger; c)Allergenic Extract White Potato; d)Allergenic Extract Lambsquarter; e)Allergenic Extract Penicillium notatum; f)Allergenic Extract Timothy Grass. Recall #B-342/347-1. CODE: a)Lot #6253; b) Lot #6392; c) Lot #6493; d) Lot #6526; e) Lot #6575; f) Lot #6600. MANUFACTURER: Allergy Laboratories, Inc., Oklahoma City, OK. RECALLED BY: Manufacturer, by letter on Nov. 2, 1999. Firm initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: a) 199/50 ml vials, 31/30 ml vials, 40/10 ml vials and 6/5 ml vials; b) 4/50 ml vials; c) 2/50 ml vials, 29/10 ml vials, 2/5 ml vials, 15/2 ml vials; d) 112/50 ml vials, 39/30 ml vials, 50/10 ml vials, 25/2 ml vials; e) 66/50 ml vials, 30/30 mlvials, 50/10 ml vials, 6/2 ml vials; f) 44/50 ml vials, 23/30 ml vials, 58/10 ml vials, 4/5 ml vials, 10/2 ml vials. REASON: Allergenic extracts, that failed finished product sterility testing, were reprocessed and distributed. ________ PRODUCT: a) Saphenous Vein; b) Medial Meniscus, Bone, Left. Recall #B-375-1. CODE: a) Serial #3758591, 3758605, 3758613; b) 4051173. MANUFACTURER: CryoLife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letters on Oct. 23, 2000. Firm initiated recall complete. DISTRIBUTION: Arizona, California, Colorado and Florida. QUANTITY: Four. REASON: Various tissue for transplants, which were collected from a donor who had not been properly evaluated, were distributed. ________ PRODUCT: Red Blood Cells, Irradiated. Recall #B-419-1. CODE: Unit 09GN47948. MANUFACTURER: American Red Cross Blood Services, Grand Island, NE. RECALLED BY: American Red Cross Blood Services, Omaha, NE, by letter on June 29, 1998. Firm-initiated recall complete. DISTRIBUTION: Nebraska. QUANTITY: One unit. REASON: Blood product,collected from a donor who reported travel to an area designated as endemic for malaria, 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 on Jan. 4, 1999. Firm initiated recall complete. DISTRIBUTION: Austria. QUANTITY: 4 units. REASON: Blood products collected from a donor whose partner had tested positive for Hepatitis B, were distributed. ________ PRODUCT: a) Red Blood Cells; b) Platelets; and c) Recovered Plasma. Recall #B-455/457-1. CODE: a) Units 18S42122 and 18R53862; b) 18R53862; c) 18S42122 and 18R53862. MANUFACTURER: American Red Cross, Lansing, MI. RECALLED BY: Manufacturer, by letter on April 2 and 3, 1998. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Five units. REASON: Blood product,which were collected from a donor who had close contact with an individual with hepatitis, were distributed. ________ PRODUCT: a) Red Blood Cells; b) Platelets; c) Fresh frozen plasma. Recall #B-458/460-1. CODE: a)Unit 3443670; b) unit 3443670; c) unit 3443670. MANUFACTURER: Michigan Community Blood Centers, Grand Rapids, MI. RECALLED BY: Manufacturer, by letter on Dec. 10, 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: b) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF; d)Recovered Plasma. Recall #B-461/464-1. CODE: a)Unit 6240871 and 6238468; b) unit 6240871; c) unit 6238468; d) 6240871 and 6238468. MANUFACTURER: Michigan Community Blood Centers, Grand Rapids, MI. RECALLED BY: Manufacturer, by letter on Dec. 10, 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; b) Platelets; c) Recovered Plasma. . Recall Nos: B-467/469-1. CODE: a) Unit 27V70270; b) Unit 27V70270; c) Unit 27V70270 MANUFACTURER: American Red Cross Blood Services, Johnstown, PA. RECALLED BY: Manufacturer, by letter on July 19,1999. 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; b) Platelets; c) Fresh frozen plasma; d) Recovered Plasma. Recall #B-474/477-1. CODE: a) Unit 27GX00670, 27GW05537, 27GV42240; b) 27GV42240; 27GV42240; d) 27GX00670; 27GW05537. MANUFACTURER: American Red Cross Blood Services, Johnstown, PA. RECALLED BY: Manufacturer, by letter on May 10, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania and West Virginia. QUANTITY: Seven units. REASON: Blood product,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; b) Recovered Plasma. Recall #B-478/479-1. CODE: a) Unit 27W82103; b) 27W82103, 27GK00294. MANUFACTURER: American Red Cross Blood Services, Johnstown, PA. RECALLED BY: Manufacturer, by letters on May 26, 1999 and June 29, 1999. Firm- initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Three Units. REASON: Blood product,collected from a donor with a history of having tested positive for hepatitis, were distributed. ________ PRODUCT: a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Frozen Plasma. Recall #B-486/489-1. CODE: a) Units 42FS55887, 42H19005, 42W11875; b) 42FS55887, 42H19005; c) 42FS55887,42H19005; d) 42W11875. MANUFACTURER: American Red Cross Blood Services, Cleveland, OH. RECALLED BY: Manufacturer, by letter on August 8, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Eight units. REASON: Blood product,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; b) Recovered Plasma. Recall #B-492/493-1. CODE: a) Unit 09GN72421; b) 09GN72421. MANUFACTURER: American Red Cross Blood Services, Omaha, NE. RECALLED BY: Manufacturer, by letter on March 27, 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: a)Red Blood Cells; b)Red Blood Cells, Irradiated. Recall #B-518/519-1. CODE: a)Unit 27J51089, 27J51092, and 27J51090; b) unit 27J51095. MANUFACTURER: American Red Cross Blood Services, Johstown, PA. RECALLED BY: Manufacturer, by letter on February 2, 1998. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: 4 units. REASON: Blood products, incorrectly tested for syphilis, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-520-1. CODE: Unit 27J14201. MANUFACTURER: American National Red Cross, Johstown, PA. RECALLED BY: Manufacturer, by letter on April 23 and May 25, 1999. Firm-initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: One unit. REASON: Blood products, manufactured from an overweight unit of Whole Blood, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-520-1. CODE: Unit 27J14201. MANUFACTURER: American National Red Cross, Johstown, PA. RECALLED BY: Manufacturer, by letter on April 23 and May 25, 1999. Firm-initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: One unit. REASON: Blood products, manufactured from an overweight unit of Whole Blood, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-524-1. CODE: Unit 27GS20999. MANUFACTURER: American National Red Cross, Johstown, PA. RECALLED BY: Manufacturer, by telephone on June 22, 1999. Firm-initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: One unit. REASON: Blood product, untested for Cytomegalovirus (CVM), but labeled as CMV negative, was distributed. ________ PRODUCT: a) Red Blood Cells; b) Recovered Plasma. Recall #B-525/526-1. CODE: a) Unit 27R53339; b) unit 27R53339. MANUFACTURER: American National Red Cross, Johstown, PA. RECALLED BY: Manufacturer, by letter on June 2, 2000. Firm-initiated recall complete. DISTRIBUTION: West Virginia and California. QUANTITY: Two units. REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-097-1. CODE: Unit 0903847. MANUFACTURER: West Tennessee Regional Blood Center, Inc., Jackson, TN. RECALLED BY: Manufacturer, by telephone on August 7, 2000. Firm initiated recall complete. DISTRIBUTION: Tennessee. QUANTITY: One Unit. REASON: Blood Product, labeled with an extended expiration date, was distributed. _________ PRODUCT: Plasma Cryoprecipitate Reduced. Recall #B-101-1. CODE: Units 12Y11099, 12FS91794, 12R95156, 12Y11129, 12Y11121, 12R91070, 12R91067, 12R91073, 12Y11113, 12F08069, 12FF96824, 12GY26848, 12GY26851, 12GY26856, 12R93726, 12R91048, 12R91065, 12R91066, 12R91069, 12R91072, 12R91078, 12R91083, 12R91085, 12Y11103, 12Y11105, 12Y11109, 12Y11110, 12Y11112, 12Y11115, 12Y11118, 12Y11119, 12Y11123, 12Y11124, 12RY11126, 12Y11128, 12Z28177, 12Z28189, and 12R1074. MANUFACTURER: American Red Cross Blood Services, Charlotte, NC. RECALLED BY: Manufacturer, by telephone on Feb. 25, 2000 and by letter on Feb. 29, 2000. Firm-initiated recall complete. DISTRIBUTION: South Carolina, North Carolina, and Massachusetts. QUANTITY: 38 units. REASON: Blood Products, which were labeled with an extended expiration date, were distributed. _________ PRODUCT: a)Red Blood Cells; b)Platelets. Recall #B-431/432-1. CODE: a)Unit G43242; b) Unit G43242. MANUFACTURER: Mid-South Regional Blood Center, Memphis, TN. RECALLED BY: Manufacturer by telephone on Dec. 29, 1997 and by letters on January 29, 1997. Firm initiated recall complete. DISTRIBUTION: Tennessee. QUANTITY: Two units. REASON: Blood products, that was not quarantined after receiving information concerning a post donation illness, were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ PRODUCT: a) Z-085-1 Sarns Turbo 440 Oxygenator with cardiotomy venous reservoir; b) Z-086-1 - Sarns Turbo 440 Oxygenator; c) Z-087-1 - Sarns low prime Oxygenator; d) Z-088-1 - Sarns low prime Oxygenator with cardiotomy venous reservoir. CODE: a) Product No. 4943; b) Product No. 5794; c) Product No. 5796; d) Product No. 4944. MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI. RECALLED BY: Manufacturer, by letter on September 29, 2000. Firm initiated recall ongoing. DISTRIBUTION: United States, Australia, Brazil, Colombia, Germany, Hong Kong, India, Japan, Malaysia, Taiwan ROC, and VA Medical Centers in Minneapolis, MN and Madison, WI. QUANTITY: a) 11,388; b) 43,605; c) 11,004; d) 5,190; Total: 71,187. REASON: Venous inlet port connector may disconnect from oxygenator. ________ PRODUCT: CryoValve Allograft. Recall # Z-145/146-1. CODE: a) Model No. AVOO - Serial Nos. 3908577, 3965244 6246443; b) Model No. PVOO - Serial Nos. 3965252, 6246451. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on October 10, 2000. Firm-initiated recall complete. DISTRIBUTION: New York, NY, Rochester, MN, Pasadena, CA and Denver, CO. QUANTITY: 5 valves. REASON: Product does not meet current guidelines regarding serodilution of plasma. ________ PRODUCT: CryoValve Allograft. Recall # Z-152/153-1. CODE: a) Model No. AVOO - Serial Nos. 3741133; b) Model No. PVOO - Serial Nos. 3741125. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on October 18, and October 20, 2000. Firm- initiated recall complete. DISTRIBUTION: Dallas, TX and Pasadena, CA. QUANTITY: 2 valves. REASON: Donor does not meet current guidelines regarding serodilution of plasma. ________ PRODUCT: LTV Series Ventilator. Recall Nos. Z-154/156-1. CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900. MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA. RECALLED BY: Manufacturer, by letter on April 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, Puerto Rico, Australia, Brazil, Canada, Colombia, Chile, China, England, Greece, Hong Kong, India, Israel, Japan, Malaysia, Mexico, New Zealand, Poland, Sweden, Taiwan ROC, Thailand. QUANTITY: 2415 Units. REASON: Failure of the LTV series ventilator software to detect a disconnect. _______ PRODUCT: LTV Series Ventilator. Recall Nos. Z-157/159-1. CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900. MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA. RECALLED BY: Manufacturer, by letter on July 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, Puerto Rico, Australia, England, Sweden, Canada, Japan, New Zealand, Switzerland, Thailand, India, Hong Kong. QUANTITY: 1213 domestic, 1103 international. REASON: Audible alarm disabled due to a metallic button migration. _______ PRODUCT: Bicor Oxygenators. a) Bicor 200 High Performance Oxygenator; b) Bicor 200 High Performance Oxygenator with integrated hard shell venous reservior. Recall Nos. Z-160-161-1. CODE: a) Lot No. R050300; Lot No. R041700. MANUFACTURER: LifeStream International, The Woodlands, TX. RECALLED BY: Manufacturer, by letter on October 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION: AR, PA, and TX and Liechtenstein and Germany. QUANTITY: 100 units, Lot R050300/ 28 units and Lot R041700/ 72 units. REASON: Device arterial port became detached. _______ PRODUCT: ROCHE Elecsys Troponin T and T Stat. Recall Nos. Z-166/167-1. CODE: T catalog number 2017644, T Stat catalog number 2017423. All Lot Numbers. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN. RECALLED BY: Manufacturer, by correction bulletin letter, on October 12, 2000. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 38,373 kits. REASON: Negative bias of approximately 30% with specimens containing potassium oxalate or sodium fluoride. _______ PRODUCT System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 systems labeled as System 1000, Altra-Touch and Althin Tina. Recall Nos. Z-0170/0173-1. CODE: a) Main Power Switch issue - Serial Nos. 01001 through 08000; b) Level Adjustment System issue - Serial Nos. 01001 through 15894, 1001S through 1142S, and 50001 through 52109. c) Particle Filter issue - Serial Nos. 01001 through 12906, 1001S through 1142S, 50001 through 52109. D) Check Value issue - Serial Nos. 01001 through 14364, 1001S through 1142S, 50001 through 52109. MANUFACTURER: Althin Medical, Inc., Miami Lakes, FL. RECALLED BY: Baxter Healthcare Corp., by letter on October 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 17145 units. REASON: a) electrical arcing emanating from main power switch; b) level adjustment pump doesn't turn off when control button released; c) ultrafiltration control valves fail to close fully; d) predialyzer valve failure causes reverse ultrafiltration.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______ PRODUCT Gynecare TVT Tension-Free. Recall # Z-115-1. CODE: Product Code: 510041; Lot Nos. PB4CPBA, PB4CPGA, PB4CQBA, PB4CQJA, PB4CQLA, PB4CQQ . MANUFACTURER: Ethicon, Inc., Somerville, NJ. RECALLED BY: Manufacturer, by letters on September 21,2000. Firm-initiated recall ongoing. DISTRIBUTION: Products were distrbuted to 48 states including Washington, DC. QUANTITY: 5,000 units. REASON: Needle Separating from the mesh.
END OF ENFORCEMENT REPORT FOR JANUARY 24, 2001.
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