October 23, 1996 96-43 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Horton's Naturally Smoked Atlantic Salmon, packaged in 4 ounce vacuum sealed plastic bags. Recall #F-017-7. CODE 212136 USE BY 9/04. MANUFACTURER Horton's Downeast Foods, Inc., Waterboro, Maine. RECALLED BY Manufacturer, by telephone on September 17, 1996. Firm-initiated recall complete. DISTRIBUTION Connecticut, Illinois, Massachusetts, Maine, North Carolina, New Hampshire, New York, Ohio, Vermont. QUANTITY 67 pounds were distributed; firm estimates none remains on the market. REASON Product was contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Nestle Strawberry Quick Powdered Drink Mix, in 16 ounce tin boxes. Recall #F-010-7. CODE 5093CN. MANUFACTURER Nestle Enterprises, Chesterville, Ontario, Canada. RECALLED BY Nestle Beverage Company, San Francisco, California, by letter August 23, 1996. Firm- initiated recall complete. DISTRIBUTION Georgia, Pennsylvania, Indiana. QUANTITY 8,550 cases were distributed; firm estimated that little if any product remained on market at time of recall initiation. REASON Product contained wood fragments. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT "The Golden Pole" chocolate covered wafer bar, 12 and 14 ounces, product of Poland. Recall #F-011-7. CODE BN 86/8094/03. MANUFACTURER Cukiernicza Spoldzielnia Pracy, Poland. RECALLED BY Eastern Star Distributing Company, Inc., Brooklyn, New York, by letter August 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 1,285 cartons were distributed; firm estimates none remains on the market. REASON The specific source of fat and oil (rapeseed) is not listed in the ingredient statement. _______________ PRODUCT Best Choice Marshmallow Fudge Cookies, in 12 ounce cellophane packages. Recall #F-012-7. CODE All product in distribution bearing the incorrect nutrient facts panel. MANUFACTURER Interbake Foods, Inc., Richmond, Virginia (responsible firm). RECALLED BY Associated Wholesale Grocers, Inc., Kansas City Kansas, via "satellite" followed by letter on September 11, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 3,000 12-package cases were distributed. REASON The nutrition facts panel of the product is incorrect. _______________ PRODUCT Viking Bakery Muffins: (a) Corn Muffins, 14 ounces; (b) Bran Muffins, 12 and 14 ounces; (c) Blueberry Muffins, 12 ounces. Recall #F-013/015-7. -2-CODE Sell by dates of AUG 28 for product manufactured 8/22/96 and AUG 29 for product manufactured 8/23/96. MANUFACTURER Operative Cake Company, doing business as Viking Cake Company, West Hartford, Connecticut. RECALLED BY Operative Cake Company, Long Island City, New York and Automated Bread, Brentwood, Long Island, New York, on August 23, 1996. Completed recall resulted from FDA/State of Connecticut contract inspection. DISTRIBUTION New York. QUANTITY (a) 552 retail units; (b) 264 retail units; (c) 96 retail units were distributed; firm estimates none remains on the market. REASON Products were contaminated with rodent filth and were prepared, packaged, and held under insanitary conditions. _______________ PRODUCT Minute Maid Premium Calcium-Rich Orange Juice, in 128 ounce plastic bottles, 96 ounce plastic bottles and 64 ounce paper cartons. Recall #F-016-7. CODE 128 ounce plastic bottles: Lot Number: Container: BEST BEFORE OCT 10, A XX:XX BEST BEFORE OCT 16, A XX:XX BEST BEFORE OCT 17, A XX:XX Shipping Case: XX:XX A OCT 10 A40575C XX:XX A OCT 16 A40676C XX:XX A OCT 17 A40649D 96 ounce plastic bottles: Lot Number: Container: BEST BEFORE OCT 15, A XX:XX BEST BEFORE OCT 16, A XX:XX Shipping Case: XX:XX A OCT 15 A40650B XX:XX A OCT 16 A40650B 64 ounce paper cartons: Lot Number: Container: XX:XX OCT 10 A1 XX:XX OCT 10 A2 XX:XX OCT 15 A1 XX:XX OCT 15 A2 XX:XX OCT 16 A1 XX:XX OCT 16 A2 XX:XX OCT 17 A1 XX:XX OCT 17 A2 -3- Shipping Case: XX:XX A OCT 10 A 40445B XX:XX A OCT 10 A 40445C XX:XX A OCT 15 A 40644B XX:XX A OCT 15 A 40644C XX:XX A OCT 16 A 40644B XX:XX A OCT 16 A 40644C XX:XX A OCT 17 A 40766C XX:XX represents a 24-hour time. MANUFACTURER Coca-Cola Foods, Anaheim, California. RECALLED BY Coca-Cola Foods, Houston, Texas, on September 23, 1996, followed by visit on or before September 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION California and Arizona. QUANTITY 24,350 cases were distributed. REASON Product has an off-flavor. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============ _______________ UPDATE Recall #D-254-6, Adrenal Cortex Injection, which appeared in the October 16, 1996 Enforcement Report, should read as follows: _______________ PRODUCT All sizes and strengths of ADRENAL CORTEX INJECTION, a Rx injectable drug, labeled as distributed by Hallmark Labs, Chicago, IL. Recall #D-254-6. CODE All codes (most units are uncoded). MANUFACTURER (primary) Ontor Beauty Products, Inc., Opa Locka, Florida. RECALLED BY Phyne Pharmaceuticals, Inc., Scottsdale, Arizona (own-label distributor); by letter mailed October 1, 1996. Firm-initiated; ongoing. See also FDA press release P96-13, August 30, 1996. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Mycobacterium abscessus contamination of unopened vial of Hallmark Labs' labeled product distributed by Phyne Pharmaceuticals and epidemiological data collected by CDC correlating the use of this product with Mycobacterium abscesses at the site of injection. RECALLS AND FIELD CORRECTIONS -- DRUGS -- CLASS III ========= _______________ PRODUCT Merck's Aquamephyton (Vitamin K) for Injection, 10 mg/ml, in 2.5 ml and 5 ml vials, indicated for use in the treatment of -4- prophylaxis and treatment of hemorrhagic disease of the newborn; anticoagulant-induced prothrombin deficiency in adults; hypoprothrombinemia due to other causes in adults. Recall #D-006-7. CODE Lot numbers: 1255A EXP 12/31/96, 0208B EXP 2/28/97, 0226B EXP 5/31/97. MANUFACTURER Merck Manufacturing Division, Division of Merck and Company, Inc., West Point, Pennsylvania. RECALLED BY Manufacturer, by letter on October 10, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Firm estimates that 10,000 market packages remained on market at time of recall initiation. REASON Product may be subpotent due to the stopper absorbing the active ingredient. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Gemini PC-1 Volumetric Infusion Pump/Controller, European 220 Volt Model V8.12. Recall #Z-001-7. CODE 645 units with individual serial numbers. MANUFACTURER IMED Corporation, San Diego, California. RECALLED BY Manufacturer, by letter dated June 18, 1996. Firm-initiated recall complete. DISTRIBUTION International. QUANTITY 645 units were distributed. REASON The pumps contain a faulty toroid (inductor) which may heat up adjacent wires causing an electrical short. _______________ PRODUCT Max-I-Probe Endodontic Irrigation Syringe: (a) Catalog # MAXE125, 3cc syringe, 25G probe, 1-2% NaOC1 solution (b) Catalog # MAXE625, 3cc syringe, 25G probe, 4-6% NaOC1 solution (c) Catalog # MAXE628, 3cc syringe, 28G probe, 4-6% NaOC1 solution (d) Catalog # MAXE630, 3cc syringe, 30G probe, 4-6% NaOC1 solution (e) Catalog # MAXE650, trial kit of 2 trays-- 1 tray of 3cc syringes and 1 tray of 10cc syringes, with each tray containing 1- 25G, -28G and 2-30G probes, with 4-6% NaOC1 solution (f) Catalog # MAXE825, 3cc syringe, 25G probe, 2-3% NaOC1 solution -5- (g) Catalog # MAXE828, 3cc syringe, 28G probe, 2-3% NaOC1 solution (h) Catalog # MAXE830, 3cc syringe, 30G probe, 2-3% NaOC1 solution. Recall #Z-007/014-7. CODE Lot numbers: (a) 96G13; (b) 96G01; (c) 96G03; (d) 96G05; (e) 96G001; (f) 96G07; (g) 96G09; (h) 96G11. MANUFACTURER MPL Technologies, Inc., Franklin Park, Illinois. RECALLED BY Manufacturer, by letter September 9, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Belgium. QUANTITY 12,455 syringes were distributed. REASON The external finger grip flanges may separate from the barrel of the syringe, rendering the syringe inoperable. _______________ PRODUCT Lifesaver Portable Oxygen Units, Catalog No. 5000, indicated for delivery of approximate low, medium and high concentrations of oxygen. Recall #Z-017-7. CODE Serial numbers: MHG9411 MHG9412 MHG9502 MHG9505 -0006 -0017 -0014 -0002 -0009 -0018 -0016 -0006 -0011 -0020 -0017 -0065 -0053 -0042 -0027 -0068 -0054 -0028 -0075 -0055 -0029 -0076 -0057 -0030 -0077 -0059 -0078 -0096. MANUFACTURER Hudson Respiratory Care, Inc., Temecula, California. RECALLED BY Manufacturer, by telephone on June 14, 1996, followed by letter on June 18 and 19, 1996. Firm-initiated recall ongoing. DISTRIBUTION California, Texas, Illinois, Pennsylvania, Utah, Missouri, Massachusetts, Canada, Honduras. QUANTITY 42 units were distributed. REASON Device was distributed with a regulator with a flow range of 1-8 LPM, instead of the correct regulator with a flow range of 2-15 LPM. _______________ PRODUCT The ThAIRapy Vest Airway Clearance System, used to provide airway clearance therapy. Recall #Z-018-7. CODE Serial numbers: 31-00001 through 31-00173. -6-MANUFACTURER American Biosystems, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer, by field correcting products beginning on or about February 8, 1996. Firm- initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 173 devices were distributed. REASON A shorting in an output transistor could allow the device blower to operate at pressures higher than specification, resulting in vest pressures constricting the thorax and impairing inspiration. _______________ PRODUCT Low Porosity Woven Vascular Prosthesis, Catalog #OLP1206, indicated for replacement or bypass procedures in aneurysmal and occlusive disease of the abdominal aorta, visceral arteries and proximal peripheral arteries exclusive of the coronary arteries. Recall #Z-019-7. CODE SERIAL NUMBERS LOT NOS. 3053001 94K18 3053003 94K18 3053007 94K18 3053008 94K18 3053009 94K18 3095001 92K09 3095002 92K09 3095003 92K09 3095004 92K09 3095005 92K09 3095006 92K09 3095007 92K09 3095008 92K09 3095010 92K09 3100603 92J18 3100604 92J18 3100608 92J18 3210201 92K02 3210203 92K02 3210204 92K02 3210205 92K02 3210206 92K02 3210207 92K02 3210208 92K02 3210209 92K02 3285301 93E21 3285302 93E21 3285304 93E21 3285306 93E21 3285307 93E21 -7- 3285308 93E21 3286301 93C26 3286302 96E17 3286303 96E17 3286304 93C26 3286307 93C26 3286309 93C26 3414701 93E21 3414702 93E21 3414703 93E21 3414706 93E21 3414709 93E21 3436101 93F30 3436404 93F30 3436409 96E17 3436410 96A10 3458903 96E17 3458906 93D30 3458907 93D30 3529702-3529708 95K13 3550001-3550004 94M16 3551001-3551010 95M01. MANUFACTURER Intervascular Inc., Clearwater, Florida. RECALLED BY Manufacturer, by telephone on August 21, 1996, followed by letter. Firm-initiated recall complete. DISTRIBUTION Tennessee, New York, Louisiana, Illinois, Alabama, Florida, California, Pennsylvania, Arizona, Georgia, Texas, New Jersey, Ohio, Japan. QUANTITY 65 unimplanted devices were in commerce at time of recall initiation. REASON One thread is missing in the involved woven vascular prothesis which may potentially increase water permeability along the line of the pulled thread. _______________ PRODUCT Input PS Catheter Introducer Sheath with Hydro/pel Coating, used to facilitate placing a catheter through the skin into a vein or artery: (a) 5F 1000511 5F 11 CM Input 2 (Freeway) 050011 5F 11 cm Input Introducer Intl. 055011 5F 11 cm Input Introducer 063311 5F 11 cm Input II Introducer 553311 5F 11 cm Input Introducer Intl 853311 5F 11 cm Input Introducer FC4631951 5F Grey Input II Assembly -8- (b) 6F 1000611 6F 11 cm Input 2 (Freeway) 060011 6F 11 cm Input Introducer Intl. 063312 6F 11 cm Input II Introducer 065011 6F 11 cm Input Introducers 563311 6F 11 cm Input Introducer Intl. 863311 6F 11 cm Input Introducer 1000623 6F 23 cm Input 2 (Freeway) 060023 6F 23 cm Input Introducer kit. 063317 6F 23 cm Input II Introducer kit FC4631952 6F Green Input II Assembly (c) 7F 1000711 7F 11 cm Input 2 (Freeway) 063313 7F ll cm Input II Introducer 070011 7F 11 cm Input Introducer Intl. 075011 7F 11 cm Input Introducer 573311 7F 11 cm Input Introducer Intl. 873311 7F 11 cm Input Introducer 1000723 7F 23 cm Input 2 (Freeway) 063318 7F 23 cm Input 2 Introd. Kit 070023 7F 23 cm Input Introducer Kit FC4631953 7F Orange Input II Assembly (d) 8F 080011 8F 11 cm Input Introducer Intl. 085011 8F 11 cm Input Introducers 080023 8F 23 cm Input 2 (Freeway) 583311 8F 11 cm Input Introducers Intl. 883311 8F 11 cm Input Introducer 063314 8F 11 cm Input II Introducer 063319 8F 11 cm Input II Introducer kit 1000823 8F 23 cm Input 2 (Freeway) 1000811 8F 11 cm Input 2 (Freeway) FC4631954 8F Blue Input II Assembly (e) 9F 063320 9F 23 cm Input 2 Introducer Kit 090023 9F 23 cm Input Introducer Kit 063315 9F 11 cm Input II Introducer 090011 9F 11 cm Input Introducer Intl. 095011 9F 11 cm Input Introducers 593311 9F 11 cm Input Introducer Intl. 893311 9F 11 cm Input Introducer FC4631955 9F Grey Input II Assembly. Recall #Z-020-024-7. CODE All lot numbers of product produced since May 1995. MANUFACTURER C.R. Bard Irl., Ballybrit, Galway. RECALLED BY USCI Manufacturing Facility, Billerica, Massachusetts, by letter on August 13, 1996, and by telephone and interoffice mail. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. -9-QUANTITY Approximately 980,539 units were distributed. REASON Introducer hub is separating at or near the weld site of the upper and lower hub body parts. Failure could result in significant blood loss or air embolism. _______________ PRODUCT Microvision-C Radiographic Film, used for mammography. Recall #Z-027/028-7. CODE Product is identified by Type, Emulsion #, Run #, and Cut#: GROUP A TYPE EMULSION RUN CUT SIZE STOCK# 597 6042 0038 ALL 18X24 529567 0050 ALL 18X24 529567 0054 ALL 18X24 529567 597 6052 0034 ALL 18X24 529567 0035 ALL 18X24 529567 0075 ALL 18X24 529567 597 6062 0034 ALL 24X30 52963A 0035 ALL 18X24 529567 0035 01-07 24X30 52963A 21-26 0036 03-07 18X24 529567 0036 01,02 24X30 52963A 0037 ALL 18X24 529567 0048 ALL 24X30 52963A 0069 03-07 18X24 529567 0069 01,02 24X30 52963A 597 6072 0078 ALL 18X24 529567 (b) GROUP B TYPE EMULSION RUN CUT SIZE STOCK# 597 6052 0036 ALL 18X24 529567 597 6062 0027 03-07 18X24 529567 0027 01,02 24X30 52963A 0032 ALL 18X24 529567 0051 ALL 24X30 52963A 0059 ALL 18X24 529567 0068 03-07 18X24 529567 0068 01,02 24X30 52963A 0070 ALL 24X30 52963A 0071 03-07 18X24 529567 0071 01,02 24X30 52063A 0072 03-07 18X24 529567 21-26 0072 01,02 24X30 52963A 0073 03,07 18X24 529567 0073 01,02 24X30 52963A 0076 ALL 24X30 52963A 0077 03-07 18X24 529567 0077 01,02 24X30 52963A 597 6072 0046 ALL 24X30 52963A 0049 ALL 24X30 52963A. -10-MANUFACTURER Sterling Diagnostic Imaging, Inc., Brevard, North Carolina. RECALLED BY Sterling Diagnostic Imaging, Inc., Newark, Delaware, by letter dated August 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Mexico, Brazil, Latin America. QUANTITY Firm estimated that 19,388 boxes of film remained on market at time of recall initiation. REASON The devices have demonstrated uncharacteristic aging, that is below working limits for speed for this product, which may result in the mis-diagnosis in mammography readings. _______________ UPDATE Invacare Oxygen Concentrators Mobilaire III/V, and Invacare III/V Oyxgentrators, Recall #Z- 1216/1219-6, which appeared in the September 25, 1996 Enforcement Report, should read as follows: _______________ PRODUCT (a) Mobilaire III Oxygen Concentrator, Model No. IRC301; (b) Mobilaire V Oxygen Concentrator, Model No. IRC501; (c) Invacare V Oxygen Concentrator, Model No. IRC 50102, with optional Oxygen, Purity Indicator. Recall #Z-1216/1218-6. CODE Serial Numbers 96B46257-94B46706, 96B99247- 96B99265 and 96B50320-96B50916 which corresponds to all of the involved devices manufactured from 1/30/96 to 2/27/96. MANUFACTURER Invacare Corporation, Sanford, Florida. RECALLED BY Manufacturer, by telephone on March 8, 1996, and October 4, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 193 units were distributed. REASON Kinked oxygen transfer hoses in the units caused by defective exterior foam insulation may affect the flow of oxygen, and therefore, affect the concentration of oxygen the patient receives. -11- END OF ENFORCEMENT REPORT FOR OCTOBER 23, 1996. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for