July 23, 1997 97-30 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Welsh Farms Ice Cream in 3 gallon bulk containers: a) Heavenly Hash Ice Cream; b) French Vanilla Ice Cream. Recall #F-513/514-7. CODE a) All date codes prior to 7/19/96 or 20196; b) All date codes prior to 8/5/96 or 21896. MANUFACTURER Welsh Farms, Inc., West Caldwell, New Jersey. RECALLED BY Welsh Farms, Inc., Long Valley, New Jersey, by letter dated August 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION New York, New Jersey, Pennsylvania. QUANTITY a) 147 cans were distributed; firm estimated that 100 units remained on market at time of recall initiation; b) 2,315 cans were distributed; firm estimated that 100 units remained on market at time of recall initiation. REASON a) The product does not bear an ingredient statement and contains undeclared egg albumin and almonds. b) The product does not bear an ingredient statement and contains undeclared egg yolks. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT No-No brand a) Salsa Diet; b) Sesame Salted Diet Tortilla Corn Flatbread, net weight 4.5 ounce. (125.6g cans). Recall #F-493/494-7. CODE All codes and serial numbers. MANUFACTURER Falcone's Cookieland Ltd, Brooklyn, New York. RECALLED BY Wedgie Dietetic Foods, Inc., Brooklyn, New York, by Fax on June 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York, New Jersey, Maryland, Pennsylvania, Massachusetts. QUANTITY a) 135 cases; b) 171 cases were distributed. REASON The product contains wheat flour but fails to declare this fact on the ingredient panel. _______________ PRODUCT Bossea brand smoked fish product, vacuum packed and individually packaged in plastic, and were of various weights: a) Bossea brand Smoked Mackerel (Whole & Fillet) b) Bossea brand Smoked Herring c) Bossea brand Smoked Eel d) Bossea brand Smoked Whitefish e) Bossea brand Smoked Rainbow Trout. Recall #F-506/510-7. CODE Smoked Whole Mackerel Code: 2087, date(s) unknown; Smoked Mackerel Fillet Code: 2078, date(s) unknown; Smoked Herring Code: 2005, date(s) unknown; Smoked Eel Code: 2082, date(s) unknown; Smoked Whitefish Code: 2081, date(s) unknown; Smoked Rainbow Trout Code: 2017, "Dec18 96", "Not To Be Sold Or Consumed After DEC 29,96". MANUFACTURER Bos Smoked Fish, Inc., Woodstock, Ontario, Canada. RECALLED BY Brooklyn Imports Inc., Brooklyn, New York, by visit on. Completed recall resulted from sample analysis and followup by the New York Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Connecticut, Michigan, Illinois, Virginia, Pennsylvania, Massachusetts. QUANTITY 932.6 pound for all five products were distributed. REASON The products contain sodium nitrite, an unapproved food additive. -2-_______________ PRODUCT Jerusalem World Pure Foods brand Turnip Pickle, a refrigerated, pickled turnip food product in clear glass quart (32 ounce) jar. Recall #F-515-7. CODE All product - The firm began coding the product as of June 11, 1997 with the Julian date. MANUFACTURER Jerusalem Natural Foods, Inc., Redford, Michigan. RECALLED BY Manufacturer, by telephone or visit by the end of June 1997. Firm-initiated recall ongoing. DISTRIBUTION Michigan and Ohio. QUANTITY Approximately 40 cases (12 quarts per case). REASON The product contains D&C Red No. 19, an unapproved color additive. _______________ PRODUCT Keebler Classic Collection French Vanilla Creme Sandwich Cookies, in 12 ounce, 24 ounce, and 300 count boxes. Recall #F-516-7. CODE All product manufactured prior to April 9, 1997 with shift codes "A", "B" and "C". The shift code precedes the three digit Julian date code of production for those cookies made in 1997 (021A made on 1/21/97, first shift), and follows the Julian date code for those cookies made in 1996 (B366 made on 12/31/96, second shift). Product made since April 9, 1997 do not contain the FD&C Yellow 5 Lake, and have the shift codes "D", "E" and "F". MANUFACTURER Pate Foods, South Beloit, Illinois. RECALLED BY Keebler Company, Elmhurst, Illinois, by memorandum dated April 10, 1997. Firm-initiated field correction (relabeling) completed. DISTRIBUTION Nationwide. QUANTITY 31,504 cases were distributed. REASON Product contained undeclared FD&C Yellow No. 5 Lake. _______________ PRODUCT No-No brand Diet Tortilla Corn Flatbreads Everything (Sesame-Poppy-Onion-Garlic), net weight 4.5 ounces (125.6g). Recall #F-517-7. CODE All codes and serial numbers. MANUFACTURER Falcone's Cookieland Ltd., Brooklyn, New York. RECALLED BY Wedgie Dietetic Foods, Inc., Brooklyn, New York, by letter on June 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Maryland, New York, Pennsylvania, Minnesota, Massachusetts, Florida. -3-QUANTITY 618 cases (12 units per case) were sold since January 1997. REASON The product contains wheat flour but fails to declare wheat flour on the label. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Hickory Farms Melt Away Mints packed in 16 ounce containers: a) Hickory Farms Melt Away Mints packed in 16 ounce clear plastic bags and in 16 ounce Hickory Farms nostalgic tins b) Hickory Farms Mini Melt Away Mints, packed in 16 ounce clear plastic bags. Recall #F-511-512-7. CODE All codes are subject to recall - catalog numbers: regular sized mints in bags - #4750; mini mints in bags - #5959; regular mints packed in nostalgic tins - #7820. MANUFACTURER Plantation Candies, Inc., Telford, Pennsylvania. RECALLED BY Hickory Farms, Inc., Maumee, Ohio, by facsimile on May 20, 1997, followed by E-mail on May 22, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 341,492 containers were distributed. REASON The product contains undeclared certified colors, FD&C Blue No. 1 and FD&C Red No. 3. _______________ PRODUCT Aloe Ginseng Cranberry Beverage, in 1 liter bottles. Recall #F-518-7. CODE 705H02. MANUFACTURER Health One's, Brooklyn, New York. RECALLED BY Natural Group, Inc., Modesto, California, by telephone. Firm-initiated recall completed on or about June 26, 1997. DISTRIBUTION California. QUANTITY Firm estimates none remains on the market. REASON The product contained undeclared dextrose. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Mexiletine Hydrochloride Capsules, 250 mg, Rx orally active antiarrhythmic used for the treatment of documented life-threatening ventricular arrhythmias, in 100 capsule bottles. Recall #D-228-7. CODE Lots 100860A, 100861A, 101262A, 104912C. -4-MANUFACTURER Novopharm Ltd., Toronto, Canada. RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by letter dated July 9, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,401 bottles were distributed; firm estimated that 25 percent of product remained on market at time of recall initiation. REASON Incorrect labeling -- Some bottles of 250 mg capsules are labeled as containing 150 mg capsules. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-792/793-7. CODE Unit #2357219. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated December 4, 1995. Firm-initiated recall completed. DISTRIBUTION Indiana and Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose spouse has a history of hepatitis C. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1035/1036-7. CODE Unit #S27628. MANUFACTURER Irwin Memorial Blood Centers, San Francisco, California. RECALLED BY Manufacturer, by letter dated March 14, 1996. Firm-initiated recall completed. DISTRIBUTION California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was listed on the State Deferred Donor Registry. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1039/1040-7. CODE Unit #41GT71886. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter on or about April 16, 1996. Firm-initiated recall completed. DISTRIBUTION Alabama. QUANTITY 1 unit of each component was distributed. -5-REASON Blood products tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), and were subjected to additional retesting which was negative. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1041/1042-7. CODE Unit #41FY80886. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter on August 28, 1996. Firm-initiated recall completed. DISTRIBUTION Alabama. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1043/1045-7. CODE Unit numbers: a) 41GM21295, 41LF44653; b) 41LF44653; c) 41GM21295, 41LF44653. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letters between April 16, 1996, and December 12, 1996. Firm-initiated recall completed. DISTRIBUTION Alabama, California. QUANTITY a) 2 units; b) 1 unit; c) 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 donors who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. _______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Plasma; d) Recovered Plasma. Recall #B-1046/1049-7. CODE Unit numbers: a) 41FV24002, 41GJ37198, 41GJ37527, 41GW08651, 41GW08967, 41KC09277, 41KC09610; b) 41GJ37198, 41GJ37527; c) 41GJ37527; d) 41FV24002, 41GJ37198, 41GW08651, 41GW08967, 41KC09277, 41KC09610, 41LG53711. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. -6-RECALLED BY Manufacturer, by letters between April 16, 1996, and December 12, 1996. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Puerto Rico. QUANTITY a) 7 units; b) 2 units; c) 1 unit; d) 7 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), but were collected from donors who previously tested repeatedly reactive for anti-HCV. _______________ PRODUCT "Blood Bank Control System" Software Program Recall #B-1051-7. CODE Software version 4.0. MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, Washington. RECALLED BY Manufacturer, by Fax on June 6, 1997. Firm-initiated field correction completed. DISTRIBUTION California, Florida, Illinois, Kansas, Pennsylvania, Texas, Washington state. QUANTITY 14 users in the U.S. which have software version 4.0 installed. REASON Computer software contains programming errors which could result in the release of unsuitable blood products. _______________ PRODUCT Source Plasma. Recall #B-1062-7. CODE Unit #HP99771. MANUFACTURER Interstate Blood Bank, Inc., Chicago, Illinois. RECALLED BY Manufacturer, by letter dated May 9, 1997. Firm-initiated recall completed. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a tattoo within 12 months of donation. _______________ PRODUCT Platelets. Recall #B-1063-7. CODE Unit #29443-7417. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on May 13, 1997. Firm-initiated recall completed. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a donor who had taken aspirin within 3 days of donation. -7-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Fresh Frozen Plasma. Recall #B-1001-7. CODE Unit numbers: 4416104, 4422379, 4422395, 4434783 6740379 6740383 7014364 7014369 7014371 7014372 7014376 7074039 7188153 7192601 7195848 7229463 7247817 7296027 7351673 7369616 7376155 7376914 7378155 7386207 7389603 7394208 7396337 7581829 7591522 7591546 7635770 7638517 7638526 7638533 7638538 7638756 7648751 7652746 7652754 7655203 7655206 7655210 7665257. MANUFACTURER New York Blood Services, also known as New York Blood Center, New York, New York. RECALLED BY Manufacturer, by letter dated January 9, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York and New Jersey. QUANTITY 43 units collected from 3/95 to 11/96 were distributed. REASON Blood products contain the preservative Adsol but not labeled as containing that preservative. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1013/1015-7. CODE Unit #1337776. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone and letters on December 13, 1996. Firm-initiated recall completed. DISTRIBUTION Kentucky and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a therapeutic donor with hemochromatosis. _______________ PRODUCT Hyp Rho-D Brand Immune Globulin (Human). Recall #B-1020-7. CODE Lot #621P15E, 621P15F. MANUFACTURER Bayer Corporation, Clayton, North Carolina. RECALLED BY Manufacturer, by letter on June 27, 1997. Firm-initiated recall completed. DISTRIBUTION Nationwide and international. QUANTITY 41,190 doses were distributed. REASON Immune Globulin tested subpotent. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-1034-7. CODE Unit #3099670. -8-MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by Fax on February 10, 1997. Firm-initiated recall completed. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was not frozen within eight hours of collection. _______________ PRODUCT Recovered Plasma. Recall #B-1038-7. CODE Unit #41GF45735. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter on June 10, 1996. Firm-initiated recall completed. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Red Blood Cells which was implicated in a transfusion reaction. _______________ PRODUCT Red Blood Cells. Recall #B-1050-7. CODE Unit #49J71353. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on April 10, 1997. Firm-initiated recall completed. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose health history screening was inadequately performed. _______________ PRODUCT Platelet Pheresis, Leukodepleted. Recall #B-1065-7. CODE Unit #40P52343. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone and fax on March 12, 1997. Firm-initiated recall completed. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed without obliteration of U.S. license. -9-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Non-Fiber Optic High Speed Dental Handpieces: a) Catalog No. 750044, Tradition Non-Fiber Optic Handpiece with conventional chuck (with wrench) b) Catalog No. 780044, Traditional L Non-fiber Optic Handpiece with Power Lever chuck (wrenchless). Recall Z-674/675-7. CODE All with date code E127 through E227. MANUFACTURER Midwest Dental Products (Dentsply), Des Plaines, Illinois. RECALLED BY Manufacturer, by letter dated May 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and China. QUANTITY 444 handpieces were distributed. REASON Some of the hand pieces may have loose fitting water spray tubes which may fall out during use, and be swallowed or aspirated. _______________ PRODUCT Advantage EMG System, Model A100, an electromyogram device used to measure and record electrical activity associated with skeletal muscle. Recall #Z-687-7. CODE All serial numbers. MANUFACTURER Advantage Medical, London, Ontario, Canada. RECALLED BY Manufacturer, by letter dated May 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 89 units were distributed. REASON The device could cause an electrical burn to the patient. _______________ PRODUCT GDXI Anatomically Correct Lifeline Patient Cable w/Leadwires, Model No. 14081 - Type A, an anatomically correct Lifeline Patient Cable to a Siemens 15 Pin Connector with lead wires, for ECG monitoring in general practitioner settings. Recall #Z-726-7. CODE Lot numbers of the cable/leadwire: C02105CH, C02504CH, and C02505CH. NOTE: The finished device kit is NOT identified with lot numbers. MANUFACTURER Graphic Controls Corporation, Cherry Hill, New Jersey. RECALLED BY Graphic Controls Corporation, Buffalo, New York, by letter dated May 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 301 sets were distributed. -10-REASON The lead wires were placed incorrectly into the cable, which caused the lead location to be mislabeled. _______________ PRODUCT Cathcor Remote 20 Inch Monitor, used with Siemens Cathcor System, an ECG recording device. Recall #Z-740-7. CODE Part numbers 61-61-942 and 08-99-019. All units. MANUFACTURER Siemens-Elema AB, Life Support Systems Division, Solna, Sweden. RECALLED BY Siemens Medical Systems, Inc., Danvers, Massachusetts, by letter on November 5, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The monitor used in a cardiac catheterization disconnected from the base pedestal and fell, causing injury. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Clinitek Atlas Reagent Pak, Product #5015, used with Clinitek Atlas Automated Urine Chemistry Analyzer. Recall #Z-727-7. CODE Lot #1A044017. MANUFACTURER Bayer Corporation, Elkhart, Indiana. RECALLED BY Manufacturer, by telephone on May 9, 1997, followed by letter. Firm-initiated recall completed. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 768 units were distributed. REASON The ketone reagent pad is missing in some of the strips in this lot. _______________ PRODUCT 1.0mm TI Burr Hole Cover, Model #420.900, used to cover a hole drilled into skull bone so as to result in a flush surface with no recesses or indentations and give a better cosmetic appearance. Recall #Z-737-7. CODE Lot #A3FN421. MANUFACTURER Synthes (USA), Monument, Colorado. RECALLED BY Synthes (USA), Paoli, Pennsylvania, by E-mail April 23, 1996. Firm-initiated recall completed. DISTRIBUTION Nationwide and Canada. QUANTITY 80 units were distributed; firm estimates none remains on the market. REASON The 1.0MM Burr Hole Cover was labeled as a 1.5MM Burr Hole Cover. -11-_______________ PRODUCT TDx/TDxFLx Estriol Reagent Pack, List No. 9112-60, used with either Total Estriol Calibrators (lists 9112-01) or Free Estriol Calibrators (list 9118-01) in a Fluorescence Polarization Immunoassay (FPIA) in-vitro estriol or free estriol in human serum, plasma or urine. Recall #Z-738-7. CODE Lot Nos. 22109Q100, 23635Q100, 25589Q100, and 26075Q100. MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico. RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letter on July 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, Kentucky, Georgia, Illinois, Indiana, Louisiana, Maryland, West Virginia, Ohio, Pennsylvania, Texas, and international. QUANTITY 1,226 reagents packs were distributed; firm estimated that 10 percent remained on market at time of recall initiation. REASON Storage of the antibody S reagent for extended time at elevated temperatures can cause heat stressing which results in depressed millipolarization values and display of the printed error code "PO Too Small" during calibration. _______________ PRODUCT Quidel QuickVue Chlamydia Test, Catalog No. B006. Recall #Z-739-7. CODE Lot Nos. B006 J04501, B006 J04801, B006 J04802, B006 J06901, B006 J08001, B006 J09001, B006 J10601, and B006 J11201. MANUFACTURER Quidel Corporation, San Diego, California. RECALLED BY Manufacturer, by telephone and by letter dated May 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,809 (30 tests/kit) kits were distributed. REASON Faint or no results are obtained with the positive control solution. _______________ PRODUCT Siemens 12 Lead ECG Patient Cable and Cable Kit, used with the Siemens Cathcor Equipment an ECG recording device: a) 12 Lead ECG Patient Cable, Part No. 0899300. b) 12 Lead ECG Cable Kit, Part No. 0899399. Recall #Z-741/742-7. CODE Lot #R0823. MANUFACTURER ConMed Corporation, Utica, New York. -12-RECALLED BY Siemens Medical Systems, Inc., Danvers, Massachusetts, by letters on May 23, 1997, and June 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 184 cables were distributed. REASON The indicator tabs for the Left Arm (LA) and Left Leg (LL) leads are reversed. -13- END OF ENFORCEMENT FOR JULY 23, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for