March 19, 1997 97-12 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Honey Roasted Cashews, in 4.5 ounce foil packages, contained in various gift baskets: Christmas catalog: 1) Grand Fruit Basket aka Royal Bistro Basket, item 8V, Net weight 14 pounds 2) 9-Star All-Occasion Basket, item 4202, Net weight 9 pounds 3) 6-Star All-Occasion Basket, item 4205, Net weight 6 pounds 4) 4-Star All-Occasion Basket, item 4559, Net weight 4 pounds January - March 1997 catalog 5) Super Deluxe Fruit Basket, item 8V, Net weight 14 pounds Recall #F-266-7. CODE AUG 14 972C and AUG 14 972D. MANUFACTURER Georgia Nut Company, Skokie, Illinois (nut packer). RECALLED BY Harry and David, Medford, Oregon (distributor), by mailgram sent on or about January 16, 1997, and by letter on January 24, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 12,100 bags were distributed. REASON Product may contain undeclared peanuts. _______________ PRODUCT Ice cream: (a) AMERICAN FARE Heavenly Hash Premium Ice Cream labeled made for "Kmart Corporation, Troy, Michigan", in half gallon round plastic containers (b) AMERICAN FARE Pralines 'N Cream Ice Cream labeled made for "Kmart Corporation, Troy, Michigan", in half gallon round plastic containers. Recall #F-268/269-7. CODE Lot numbers: (a) 635926-875B; (b) 635826-875B. MANUFACTURER Michigan Dairy, Livonia, Michigan. RECALLED BY Manufacturer, by telephone, followed by letter on January 14, 1997, and by press release issued by Kmart Corporation and The Kroger Company on January 14, 1997. Firm-initiated recall complete. DISTRIBUTION Texas, Florida, Ohio, Georgia, North Carolina, South Carolina. QUANTITY (a) 1,712 cartons; (b) 1,597 cartons were distributed. REASON (a) The product contains undeclared peanuts. (b) The product contains undeclared pecans. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Stoneware Dinner Sets with Christmas Tree Design, 16 piece sets, service for four. Recall #F-262-7. CODE Item #94605 on outer box. MANUFACTURER Fei Na Te Ceramic Company, Ltd., Hebei, China. RECALLED BY C.R. Seasons Ltd., Farmingdale, New York, by telephone, followed by letter dated January 9, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York, South Carolina, Pennsylvania, Massachusetts, Vermont, Connecticut, Florida. QUANTITY 12,430 cartons (37,290 sets) were distributed. REASON The dinner set contains excessive levels of leachable lead. _______________ PRODUCT Carnival Pink Lemon Fruit Drink, in 1 gallon plastic jugs. Recall #F-265-7. CODE All codes. MANUFACTURER Superior Dairy, Inc., Canton, Ohio. RECALLED BY Manufacturer, by telephone beginning on February 21, 1997. Firm-initiated recall ongoing. -2-DISTRIBUTION Ohio, West Virginia, Pennsylvania, Michigan. QUANTITY Undetermined. REASON Product contains undeclared FD&C Yellow No. 5. _______________ PRODUCT Pasteurized Liquid Whole Eggs, packed in 30 pound/5 gallon buckets. Recall #F-267-7. CODE Lot #3236. MANUFACTURER Quaker State Farms, Inc., Klingerstown, Pennsylvania. RECALLED BY Manufacturer, by telephone on November 26, 1996. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and New Jersey. QUANTITY Firm estimates none remains on the market. REASON Product was contaminated with salmonella. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Sun Dried Tomatoes, in 3 ounce plastic containers with a snap on lid. Recall #F-261-7. CODE None. All product in distribution. MANUFACTURER South Mill Mushroom Sales, Inc., Kennett Square, Pennsylvania (repacker/responsible firm). RECALLED BY Repacker, by telephone, followed by letter dated January 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York, Massachusetts, Iowa, Texas, California, Bermuda. QUANTITY 78 cases (12 containers per case) were distributed. REASON Product contains undeclared sulfites. _______________ PRODUCT Golden Maple Leaf brand Dried Sweet Potato, in 7 ounce and 14 ounce plastic bags. Recall #F-263-7. CODE None. MANUFACTURER Taishin City Daxin Haufeng Food Co., Ltd., Taishin City Guangdong, China. RECALLED BY Blooming Imports, Inc., Brooklyn, New York by telephone and by letter dated October 7, 1996. Ongoing recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 97 7-ounce cartons and 20-ounce cartons were distributed. REASON Product contains undeclared sulfites. -3-_______________ PRODUCT Free Supreme Fat Free Ice Cream with Nutrasweet, Chocolate Ripple Flavor, in half gallon plastic rounds. Recall #F-264-7. CODE The ice cream is identified with one of three codes: "351 6", "015 7", and "041 7". The ice cream branded with the code 051 6, was manufactured on 12/16/96; the product identified with the code 015 7, was manufactured on 1/15/97; and the product coded 041 7, was manufactured on 2/10/97. MANUFACTURER Superior Dairy, Inc., Canton, Ohio. RECALLED BY Manufacturer, by telephone beginning on February 25, 1997, followed by visit. Firm- initiated recall ongoing. DISTRIBUTION Ohio, West Virginia, Pennsylvania, Michigan, New Jersey. QUANTITY 1,137 cases (6,822 rounds) were distributed; firm estimated that 80 percent of product produced remained on market at time of recall initiation. REASON The product does not bear the warning statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" as required by 21CFR 172.804. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ========== _______________ PRODUCT Oxygen, USP, Rx in portable aluminum cylinders, sizes B, C, D, and E. Recall #D-124-7. CODE All codes distributed between November 13, 1996 and January 31, 1997. MANUFACTURER Mersco Medical, Inc., Sioux Falls, South Dakota. RECALLED BY Eastern Dakota Health, doing business as Mersco Medical, Inc., Sioux Falls, South Dakota, by visits on or about February 3, 1997. Firm-initiated recall ongoing. DISTRIBUTION Minnesota, Iowa, South Dakota. QUANTITY Undetermined. All product distributed from 11/13/96 to 1/31/97. REASON Good manufacturing practice deficiencies. _______________ PRODUCT Diltiazem Hydrochloride Extended Release Capsules, USP, 60 mg, in bottles of 100, Marketed under the Lemmon label, used for the treatment of hypertension. Recall #D-125-7. CODE Lots OB 6780 EXP 5/98 and OB 6781 EXP 6/98, distributed between 12/9/96 and 1/28/97. -4-MANUFACTURER Prographarm Laboratories S.A., France (responsible firm). RECALLED BY Teva Pharmaceuticals, Sellersville, Pennsylvania, by letter dated January 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 25,000 bottles. REASON Product fails to meet dissolution specification (lot ob 6781 assays as low as 48% after 12 hours; spec is 55-80%). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Cefadroxil Capsules, USP, 500 mg, in bottles of 24, 50, 100, indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli, and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis/tonsillitis caused by group A beta-hemolytic streptococci. Recall #D-126-7. CODE Lot numbers: 4301-039 EXP 6/98, 4801-039 EXP 6/98, 6068-039 EXP 6/98. MANUFACTURER Zenith Goldline Pharmaceuticals, Inc., Pralex Corporation, Christiansted, Virgin Islands. RECALLED BY Manufacturer, by letter dated February 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 8,410 bottles were distributed. REASON Fails to meet dissolution specification at the 6-month stability testpoint (assay is 78% of label strength; spec is not less than 85% after 30 minutes). ______________ PRODUCT Mechanical Servants brand Regular Afrin Nasal Decongestant 12 Hour Nasal Spray, (Oxymetazoline HCl, USP), 0.05% in a 1/10 fluid ounce spray bottle. Recall #D-127-7. CODE Lot #6-CFC-100 EXP 6/98. MANUFACTURER Schering-Plough Healthcare Products, Memphis, Tennessee. RECALLED BY Mechanical Servants, Inc., Chicago, Illinois, by letter dated March 3, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 14,405 units were distributed; firm estimated that 25 percent of product remained on market at time of recall initiation. -5-REASONS Some outer packages are labeled with an incorrect expiration date (the expiration date may appear as "10/97" or "6/98"). The bottles bear the correct expiration date. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-226-7. CODE Unit #20LY04214. MANUFACTURER American Red Cross Blood Services, Boise, Idaho. RECALLED BY Manufacturer, by telephone on July 2, 1996. Firm-initiated recall complete. DISTRIBUTION Idaho. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner which compromises the sterility of the collection system. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-324/325-7. CODE Unit numbers: (a) 32GW36179, 32GW41876; (b) 32GW41876. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated October 18, 1995. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY (a) 2 units; (b) 1 unit was distributed. REASON Blood products were collected from a donor who had previously reported a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-407-7. CODE Unit #21Q49876. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter June 6, 1996. Firm- initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. _______________ PRODUCT Platelets. Recall #B-413-7. CODE Unit #15286-4452. MANUFACTURER United Blood Services, Lubbock, Texas. -6-RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by letter on February 28, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-437/440-7. CODE Unit numbers: (a) 32H01431, 32H24383; (b) 32H01431; (c) 32H24383; (d) 32H01431, 32J13749. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated March 13, 1996, or May 28, 1996, and by Fax on March 13, 1996. Firm-initiated recall complete. DISTRIBUTION Wisconsin and California. QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 2 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-441/443-7. CODE Unit #32F85453. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated August 18, 1995, September 7, 1995, or November 4, 1996, and by fax on September 5, 1995. Firm- initiated recall complete. DISTRIBUTION Wisconsin, Illinois, New Jersey, California Massachusetts, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested initially reactive for the hepatitis B surface antigen (HBsAg), and were not retested as required; or were collected from a donor who was previously tested incorrectly for HBsAg. _______________ PRODUCT Red Blood Cells. Recall #B-448-7. CODE Unit #1382803. -7-MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on August 10, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for syphilis, but was not retested in accordance with the manufacturer's test kit instructions. _______________ PRODUCT Platelets, Pheresis. Recall #B-455-7. CODE Unit #KZ37936 and KZ37595. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on November 7, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who had traveled to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-460/461-7. CODE Unit #29Y26767. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated February 1, 1996, and March 7, 1996, and by memorandum dated January 16, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia and Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products tested initially reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), and were not retested in duplicate. _______________ PRODUCT Red Blood Cells. Recall #B-462-7. CODE Unit #T31202. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on October 4, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of ear piercing within 12 months of donation. -8-_______________ PRODUCT Platelets, Pooled. Recall #B-463-7. CODE Unit #126. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on October 25, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration time. _______________ PRODUCT (a) Red Blood Cells. Recall #B-464-7. CODE Unit #40GJ11210. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on October 22, 1996, followed by letter dated October 23, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. _______________ PRODUCT Platelets. Recall #B-469-7. CODE Unit #11313-8133. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by letter on October 15, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit with an extended collection time. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-473/474-7. CODE Unit #40GT45599. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on July 25, 1996, followed by letter dated July 31, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were subjected to additional retesting. -9-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== ______________ PRODUCT Recovered Plasma. Recall #B-326-7. CODE Unit #32GW36179. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by Fax on October 17, 1995. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had previously reported or a history of cancer. _______________ PRODUCT (a) Platelets. Recall #B-348-7. CODE Unit numbers: 5570811 5570851 5570881 5825491 5570821 5570861 5570891 5738741 5570841 5570871 5825481. MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on July 7, 1995. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 11 units were distributed. REASON Blood products were distributed prior to completion of testing for the antibody to the hepatitis B core antigen (anti-HBc). _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-421/422-7. CODE Unit #53K16896. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letters dated February 15 and 20, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had been immunized with Measles, Mumps, and Rubella (MMR) vaccine. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-426-7. CODE Unit #29135-4108. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on July 22, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. -10-REASON Blood product was prepared from a unit of whole blood designated as a difficult collection. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-444/447-7. CODE Unit numbers: (a) 32H44790, 32H74393, 32F05171, 32H87632, 32H01007, 32K74428, 32GQ03590, 32K98221, 32LH18254, 32GW11991, 32FF20952, 32GW34796; (b) 32H74393, 32F05171, 32H87632, 32H01007, 32K98221, 32LH18254, 32GW11991; (c) 32H44790, 32F05171, 32H87632; (d) 32H74393, 32H01007, 32K74428, 32K85116, 32GQ03590, 32K98221, 32LH18254, 32GW11991, 32FF20952, 32GW34796. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated August 18, 1995, September 7, 1995, or November 4, 1996, or by Fax on September 5, 1995. Firm-initiated recall complete. DISTRIBUTION Wisconsin, Illinois, New Jersey, Massachusetts, California, Switzerland. QUANTITY (a) 12 units; (b) 7 units; (c) 3 units; (d) 10 units were distributed. REASON Blood products tested initially reactive for the hepatitis B surface antigen (HBsAg), and were not retested as required, or were collected from a donor who was previously tested incorrectly for HBsAg. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-449/451-7. CODE Unit #2706070. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by Fax followed by telephone on March 16, 1995. Firm-initiated recall complete. DISTRIBUTION Texas and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose spouse tested positive for the antibody to the human T-lymphotropic virus type II (anti-HTLV-II). _______________ PRODUCT Red Blood Cells. Recall #B-452-7. CODE Unit #30R27570. -11-MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated November 7, 1995. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was shipped interstate. _______________ PRODUCT Platelets, Pheresis. Recall #B-454-7. CODE Unit #KZ38852. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on October 2, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was shipped interstate. _______________ PRODUCT Recovered Plasma. Recall #B-465-7. CODE Unit #40GJ11210. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letter on October 24, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Cobe Centrysystem HG Dialyzer, used in chronic hemodialysis procedures to remove body wastes and water from the blood: (a) 600 HG Dialyzer; (b) 700 HG Dialyzer. Recall #Z-295/296-7. CODE Lot numbers: (a) G07B5291, G07B5292, G07B5293, G07B5294, G08B5292, G09B5291, G09B5293, G09B5294, G10B5291, G10B5292, G10B5293, G11B5291; (b) G10B5311, G10B5312, G10B5313, G11B5311, G11B5313, G01C5311. MANUFACTURER Secon GMBH, Dransfeld, Germany. RECALLED BY Gambro Healthcare, Lakewood, Colorado, by telephone followed by FedEx on January 31, 1997. Firm-initiated recall ongoing. -12-DISTRIBUTION Colorado, District of Columbia, Florida, Illinois, Kentucky, Missouri, New York, Tennessee, Virginia, Washington state, Wisconsin, Canada. QUANTITY (a) 11,740 units; (b) 13,980 units were distributed. REASON The blood in the dialyzers was leaking from the blood side into the dialysate. _______________ PRODUCT SPUR Infant/Child Resuscitator, single use. Recall #Z-309-7. CODE Catalog Nos. (Old Catalog Nos.) 430013000 (243004000) 430013001 (243004000001) 430014000 (2430050NIT) 430015000 (243001000004) 430015002 (n/a) 430017000 (n/a) 430613000 (243004600) 430613001 (2430046000001) 430613002 (243004600002) 430613003 (n/a) 430614000 (2430056NIT) 430614004 (n/a) 430814000 (243006000NIT) 431813000 (243014000) 431813002 (243014000002) 431814000 (243009800 &243015000NIT) 431815000 (243014000IT) 431817000 (n/a) Discontinued Catalog Nos. 430013002 (243004000002) 430014002 (2430050NIT002) 430014004 (n/a). MANUFACTURER Ambu, Inc., Linthicum, Maryland. RECALLED BY Manufacturer, by letter dated June 21, 1995. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 48,315 units were distributed; firm estimates none remains on the market. REASON The patient mask connector can cause deformation of the resuscitator connector, resulting in inability to connect an endotracheal tube for a patient to be intubated. _______________ PRODUCT Medtronic Synchromed Programmable Pumps: (a) Model #8617-18; (b) 8617L-18. Recall #Z-310/311-7. CODE None. -13-MANUFACTURER Medtronic, Inc., Neurological Division, Columbia Heights, Minnesota. RECALLED BY Manufacturer, by letter on January 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 97 pumps were distributed. REASON The infusion pump could leak, resulting in corrosion of the components, causing a motor stall condition. _______________ PRODUCT Angio-Seal Hemostatic Puncture Closure Device, 8 French, indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty procedures using an 8F or smaller procedural sheath: (a) Catalog No. 8888-610089; (b) Catalog No. 1180-580050. Recall #Z-312/313-7. CODE Lot Numbers: (a) 879905, 880245, 880445, 880446, 881486, 881700; (b) 881474, 96I041E, 96I201E. MANUFACTURER Quinton Instrument Company, Bothell, Washington. RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by letter dated January 27, 1997, and by telephone on January 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Between 9/30/96-1/21/97, 2,090 devices in the U.S. and 2,272 devices internationally were distributed. REASON During deployment, the devices anchor may become detached from the remainder of the device, remaining within the femoral artery of the patient. _______________ PRODUCT Kendall Sheridan JETTX Jet Ventilation/Tracheal Tube Exchanger, used as a airway management system. Recall #Z-314-7. CODE Product #5-24205, Lot #051472. MANUFACTURER Kendall Healthcare, Argyle, New York. RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts, by overnight mail on January 31, 1997, and February 3, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. -14-QUANTITY 470 units were distributed. REASON The Luer Lock Adapter may be missing, preventing attachment of conventional jet ventilation devices to the tracheal tube exchanger. _______________ PRODUCT Aero-Mist Nebulizer/Compressor System, Reorder #HCS 1200, a disposable home use nebulizer used to atomize liquid medications for inhalation, normally used by asthmatics. Recall #Z-315-7. CODE Lot numbers 601 and 604, Serial numbers 13003- 22000. MANUFACTURER Medel Italiana S.R.L., Polo Di Torrile (PR), Italy. RECALLED BY Medline Industries, Inc., Mundelein, Illinois, by letter dated February 18, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 6,100 units were distributed. REASON The units may experience a drop in air pressure over time during use, causing difficulty in administering the recommended dosage of medication. _______________ PRODUCT Model 531-30 (software) Rx2000 Program Module, an electronic memory cartridge containing instructions needed by the Model 522-06 Rx2000 graphics programmer to program and obtain data from Intermedics Res-Q Arrhythmia Control, life support devices. Recall #Z-316-7. CODE All lots. Serial numbers involved range within #1330-1657 and #101680-102337. Manufactured from August 24, 1990 to current. MANUFACTURER Intermedics, Inc., Angleton, Texas. RECALLED BY Manufacturer, by letter sent on February 3, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Lebanon. QUANTITY 280 units were distributed. REASON A software condition can cause inappropriate programming of parameter data that can result in undersensing, oversensing, and loss of capture. _______________ PRODUCT Toshiba Digital Gamma Cameras, used to perform a wide range of nuclear medicine examinations: (a) Model No. GCA-7100A -15- (b) Model No. GCA-7200A (c) Model No. GCA-7100A/DI (d) Model No. GCA-7200A/DI. Recall #Z-317/320-7. CODE All serial numbers. MANUFACTURER Toshiba Corporation, Tochigi, Japan. RECALLED BY Toshiba America Medical Systems, Inc., Tustin, California, by letter on November 18, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 76 units are installed. REASON Allen head bolts located in the rotating assembly drive train section had been sheered off, allowing the single head assembly to rotate freely between 90 to 270 degrees beneath the patient. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Nellcor-Equipped MicroDigitrapper-S/Oxy- Holter, used in the diagnosis of sleep disorders. Recall #Z-301-7. CODE Various serial numbers. MANUFACTURER Synectics Medical, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter on November 2, 1995. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 103 units were distributed. REASON The device experiences loss of pulse-oximetry data from high artifact levels due to a design problem. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ========== __________________ PRODUCT Master Mix P-S-Y Lax PAC 7926, nonmedicated feed for the relief of constipation of sows. Recall #V-029-7. CODE Lot #478106. MANUFACTURER ADM Animal Health and Nutrition Division, Des Moines, Iowa. RECALLED BY Manufacturer, by letter on November 7, 1997. Firm-initiated recall complete. DISTRIBUTION Nebraska. QUANTITY 299 20-pound bags were distributed; firm estimates none remains on the market. REASON The product was manufactured following the manufacture of an experimental batch of Type B medicated feed which contained the new animal drug tilmicosin. No clean-out occurred between production. -16-__________________ PRODUCT SCNS Pig Charger 500 Xtra, nonmedicated feed. Recall #V-030-7. CODE Lot #593086. MANUFACTURER ADM Animal Health and Nutrition Division, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on October 25, 1996, followed by letter on November 7, 1996. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 41 50-pound bags were distributed. REASON The product was manufactured following the manufacture of an experimental batch of Type B medicated feed which contained the new animal drug tilmicosin. No clean-out occurred between production. _______________ PRODUCT "Go Dry" Dry Cow Mastitis Treatment, Penicillin G Procaine in Sesame Oil, (10 mL syringe) for the treatment of bovine mastitis in dry cows. Recall #V-031-7. CODE H 5430 - Exp. February 1999. MANUFACTURER G C Hanford Manufacturing Company, Syracuse, New York. RECALLED BY Manufacturer, by telephone on February 19, 1997, followed by letter on February 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Iowa, Kentucky, Massachusetts, Mississippi, Missouri, Nebraska, New Mexico, New York, Pennsylvania, Wisconsin, West Virginia. QUANTITY 76,116 syringes were distributed. REASON Product is packaged in cartons labeled for lactating cow mastitis treatment "Hanford's Penicillin Lactating Cow Mastitis Treatment." -17- END OF ENFORCEMENT REPORT FOR MARCH 19, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for