October 29, 1997 97-44 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Oriental Mascot brand Dried Sweet Potato, in plastic bags (Heat Sealed), net weight 8 ounces, 100 bags per carton. Recall #F-031-8. CODE None. All product with undeclared sulfites. MANUFACTURER Unknown. RECALLED BY Summit Import Corporation, New York, New York (importer), by letter on December 9, 1996, followed by telephone on January 3, 1997. Firm-initiated recall complete. DISTRIBUTION New York, Ohio, Connecticut, Pennsylvania, North Carolina, Maryland, Illinois. QUANTITY 30 cartons (100 x 8 oz. bags) were distributed. REASON The product contains undeclared sulfites. _______________ PRODUCT Silken Tofu under the Nasoya and Vitasoy labels, in 19 ounce flexible plastic tubs. Recall #F-032-8. CODE "USE BY:JUN04_", where the blank may be "A", "B", or "C". MANUFACTURER Nasoya Foods, Inc., Leominster, Massachusetts. RECALLED BY Manufacturer, by telephone June 13, 16, and 17, 1997. Firm-initiated recall complete. DISTRIBUTION Massachusetts, Maine, Florida, New York, New Jersey. QUANTITY Firm estimates none remains on the market. REASON Product was found to be contaminated with Salmonella sp.Group E2. _______________ PRODUCT A "Cleansing Herbal Dietary Supplement." The "Chomper" product is promoted as an "herbal laxative" and "cleansing" agent to be used as part of a regimen of dietary products distributed by this company: a) Chomper 350; b) Chomper 100 c) Chomper with Cayenne 100 d) Chomper with Cayenne 270 e) Chomper, bulk, 8.8/9.0 oz Recall #F-033/037-8. CODE 350 COUNT (TABS): 703118, 703119, 703120, 703121, 703126, 703127, 703128, 703129, 100 COUNT (TABS): 703131 250 GRAM/8.8 OZ. (BULK-POWDER): 703238 350 COUNT (TABS) & 100 COUNT (TABS) & BULK (9.00 OZ. POWDER): D6409, 027041, 027042. All lots of Chompers produced by ABCO and JMI. MANUFACTURER ABCO Inc., Concord, California, & JMI Phoenix Laboratories, Inc., Tempe, Arizona. RECALLED BY Arise & Shine, Mt. Shasta, California, by telephone, followed by letters on May 9 and 30, 1997, and June 9, 1997. Firm-initiated recall ongoing. See also FDA press release P97-14, 1997, May 16, 1997, and FDA Statement dated June 12, 1997. DISTRIBUTION Nationwide and international. QUANTITY Firm estimated that very little product remained on market at time of recall initiation. REASON The product is contaminated with Digitalis. _______________ PRODUCT Plantain Leaves both cut and powdered. Recall #F-038/039-8. CODE Lots 15-791, 16-121, and 16-338, lots 15-791 consists of both cut plantain leaves and powdered plantain, the other lots are cut. MANUFACTURER Herbarium, Inc., Kenosha, Wisconsin. RECALLED BY Manufacturer, by letter dated June 20, 1997. Firm-initiated recall complete. See also FDA Statement dated June 12, 1997. DISTRIBUTION California, Illinois, Iowa, Michigan, New Jersey, New York, Pennsylvania. -2- QUANTITY 5735 pounds of cut plantain leaves and 950 pounds of powdered plantain leaves were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain Leaves both cut and powdered. Recall #F-040/041-8. CODE All product distributed between 7/13/95 and 5/97. MANUFACTURER Nature's Cathedral, Inc., Blairstown, Iowa. RECALLED BY Manufacturer, by telephone on June 16, 1997, followed by letter. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Colorado, Iowa, Utah, California, Oregon, Michigan, New York, Vermont, Massachusetts, Arizona, Florida, Washington state, Canada. QUANTITY 6,040.5 pounds plantain cut and sifted and 24 pounds of plantain powder were distributed since 2/96. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain Leaves both cut and powdered, in 1 pound poly bags. Recall #F-042/043-8. CODE All product distributed between 7/20/95 to 6/4/97. MANUFACTURER Ameriherb, Inc., Ames, Iowa. RECALLED BY Manufacturer, by telephone beginning June 7, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide. QUANTITY 166 pounds cut and 13 pounds powder were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain Leaves, in 1 pound - 5 pound bags. Recall #F-044-8. CODE 0205B, 0404B, and 0526B. MANUFACTURER Pacific Botanicals, Grant Pass, Oregon. RECALLED BY Manufacturer, by telephone beginning June 25, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide and Canada. QUANTITY 93.66 pounds were distributed. REASON Product was contaminated with Digitalis. glycosides. -3- _______________ PRODUCT Uriseptic Tea. Recall #F-045-8. CODE None. MANUFACTURER Wise Woman Herbals, Creswell, Oregon. RECALLED BY Manufacturer, by fax and telephone on June 10, 1997, and letter June 23, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997 DISTRIBUTION California, Hawaii, Massachusetts, Oregon, Pennsylvania, Vermont, Washington state, Canada. QUANTITY 21.5 pounds were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain Leaves, cut and sifted, dry repacked from bulk into 1-pound clear plastic bags. Recall #F-046-8. CODE All product received from supplier between 2/1/96 and 6/6/97. MANUFACTURER Trinity Herb, A Division of Trinity Enterprises, Inc., Sebastopol, California. RECALLED BY Manufacturer, by letter on June 23, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide and Canada. QUANTITY 245 pounds were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain and herbal extracts in 1 ounce and 4 ounce bottles: (a) PURE HERBS Brand Plantain extract (b) PURE HERBS Brand E.T.B.-M (c) PURE HERBS M. & B.-A (d) PURE HERBS G.F.-G. (e) M.& B.-A (computer printed label) (f) L.L. -F. (LNGV) (computer printed label). Recall #F-047/052-8. CODE Lot numbers: a) 072, 081, 082, 083, 091, 092. (b-f) All lots. MANUFACTURER Ameriherb, Inc., Ames, Iowa (supplier). RECALLED BY Pure Herb, Ltd., Madison, Wisconsin, by letter on August 4, 1997. Firm-initiated recall ongoing. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide and Canada. QUANTITY Approximately 1,100 bottles of plantain extract and an unknown quantity of the other products were distributed. -4- REASON Product were contaminated with Digitalis glycosides. _______________ PRODUCT Nature Cleanse Tablets (Nature's Plus & BotaniCleanse brands). 90 tablets per bottle. Recall #F-053-8. CODE Lot numbers: 28437, 28800, 28857, 29641 and product numbers 1138 & 1140. MANUFACTURER National Nutritional Laboratories, Inc., Huntington Station, New York. RECALLED BY Natural Organics, Inc., Melville, New York, by letter on July 25, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Plantain Extract in 1 ounce, 4 ounce, and « gallon containers. Recall #F-054-8. CODE Lots 0000015 through 0000023. MANUFACTURER Good Herbs, Inc., Troy, Michigan. RECALLED BY Manufacturer, by telephone beginning July 10, 1997. Firm-initiated recall complete. See also FDA statement dated June 12, 1997. DISTRIBUTION Nationwide and Canada. QUANTITY 128 1-ounce bottles, 113 4-ounce bottles and 3-half gallon bottles were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Blessed Herbs Plantain Herb, Wildcrafted, 1 pound. Recall #F-055-8. CODE Lot #L428C. MANUFACTURER Blessed Herbs, Oakham, Massachusetts. RECALLED BY Manufacturer, by letter on July 7, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 153 1-pound packages were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT a) Plantain Leaf, cut/sifted, wildcrafted; b) ABDO-MENDS Tea. Recall #F-056/057-8. CODE None. MANUFACTURER Jean's Greens, Newport, New York. -5- RECALLED BY Manufacturer, by telephone , followed by letters dated June 16 and 26, 1997. Firm-initiated recall complete. See also FDA press release P97-14, May 14, 1997, and FDA statement dated June 12, 1997. DISTRIBUTION Nationwide, Japan, France. QUANTITY a) 12 pounds; b) 50 cups (loose tea) - sold in 2-cup bags and 2,461 bags were distributed. REASON Product was contaminated with Digitalis glycosides. _______________ PRODUCT Sprout products, with the exception of the snow pea sprouts, the products are packaged in 12-packs containing 4-oz. plastic cups which are labeled with the company name. All of the sprout varieties are also packaged in 2-lb. unlabeled plastic bags. With the exception of the snow pea sprouts, all of the varieties are packaged in 5-lb. unlabeled plastic bags contained inside of a labeled case: a) First Harvest Alfalfa Sprouts b) First Harvest Mung Bean Sprouts c) First Harvest Mixture (adzuki, lentils, green pea) d) First Harvest Radish Sprouts e) First Harvest Spicy Sprouts (alfalfa and radish) f) First Harvest Crispy Sprout Mix (green peas, Chinese red beans, lentils) g) Snow Pea Sprouts. Recall #F-058/063-8. CODE All product. MANUFACTURER First Harvest, Kansas City, Kansas. RECALLED BY Manufacturer, by telephone on June 2&3, 1997. Firm-initiated recall complete. DISTRIBUTION Kansas and Missouri. QUANTITY Firm estimates none remains on the market. REASON The sprouts were found contaminated with Salmonella Anatum and/or Salmonella Infantis and were associated with an outbreak of salmonellosis. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============ _______________ PRODUCT Amicar Syrup, 25%, in 16 ounce bottles, useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Recall #D-017-8. CODE Lot numbers: 445-578 EXP MAR00 and 446-877 EXP APR00. MANUFACTURER Lederle/Wyeth Ayerst Pharmaceuticals, Pearl River, New York. -6- RECALLED BY Immunex Corporation, Seattle, Washington, by fax on September 17, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,215 bottles of lot 445-578 and 133 bottles of lot 446-877 were distributed. REASON Product is contaminated with Candida parapsilosis (yeast). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ========== _______________ PRODUCT Belladonna Alkaloids with Phenobarbital Tablets, (Phenobarbital USP 16.2 mg/Hyoscyamine Sulfate USP 0.1037 mg/Atropine Sulfate USP 0.0194/Scopolamine Hydrochloride USP 0.0065 mg), in bottles of 100 and 1,000. Product is sold as Bellatal and Rexatal under the Richwood label and as Hyosophen under the Rugby label. The drug provides peripheral anticholinergic/antispasmodic action and mild sedation is prescribed for use in the treatment of irritable bowel syndrome and acute enterocolitis. Recall #D-020-8. CODE Lot numbers: B3899 EXP 10/97, B3916 EXP 1/98, B3917 EXP 1/98, 61008 EXP 10/98, 61009 EXP 10/98, 61204 EXP 12/98, 70107 EXP 1/99, 70301 EXP 3/99, 70302 EXP 4/99, 70407 EXP 4/99, 70616 EXP 7/99, 70702 EXP 7/99. MANUFACTURER Richwood Pharmaceuticals Company, Inc., doing business as Manufacturing Chemists Company, Indianapolis, Indiana. RECALLED BY Richwood Pharmaceuticals Company, Inc., Florence, Kentucky, by letter faxed on October 8, 1997, followed by mail. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 29,123,000 tablets were distributed. REASON Product failed content uniformity testing for Belladonna Alkaloids. _______________ PRODUCT Claforan Sterile (cefotaxime sodium) equiv. to 1 g cefotaxime IM/IV, in cartons of 25 vials, a broad spectrum antibiotic. Recall #D-021-8. CODE Lot #97H3W (cartons), 97H3W1 and 97H3W2 (vials). MANUFACTURER Hoechst Marion Roussel, Frankfort, Germany (bulk powder). RECALLED BY Hoechst Marion Roussel, Kansas City, Missouri, by letter dated September 2, 1997, followed by telephone on September 3, 1997. Firm-initiated recall ongoing. -7- DISTRIBUTION Nationwide. QUANTITY 99,550 vials were distributed. REASON Glass particles in vials. RECALLS AND FILED CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Aredia (Pamidronate disodium for Injection), lyophilized powder for reconstitution, 30 mg/vial, Rx indicated for the treatment of patients with moderate to severe Paget's disease. Recall #D-255-7. CODE Lot numbers: 1005800 EXP MAY 98, 1006000 EXP JUN 99. MANUFACTURER Product is labeled as manufactured by Ciba-Geigy Ltd., Basile, Switzerland and Distributed by Ciba Pharmaceutical Co., Division of Ciba-Geigy Co., Summit, New Jersey. RECALLED BY Novartis Pharmaceutical Corporation, Summit, New Jersey, by letter on December 10, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 46,760 vials were distributed. REASON Labeling error -- Immediate vial label is missing dosage strength statement. _______________ PRODUCT Hytone (Hydrocortisone) 2-1/2% Cream, packaged in tubes of 3.5 g (professional sample size), Rx topical cream used for the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Recall #D-278-7. CODE Lot #MN0969 EXP 6/30/98. MANUFACTURER Rhone-Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico. RECALLED BY Dermik Laboratories, Inc., (a Rhone Poulenc Rorer Co.) Collegeville, Pennsylvania, by letter July 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Firm estimates little if any product remained on market at time of recall initiation. REASON Out of specification assay (high) and incorrect expiration dating; product labeled with 48 months in contrast to correct 24 months after manufacturing. _______________ PRODUCT Barre brand Dihistine DH Elixir, Cough Suppressant/Nasal Decongestant /Antihistamine (Codeine Phosphate/Pseudoephrine -8- Hydrochloride/Chlorpheniramine maleate), in 4, 8, 16, and 164 (1 gallon) containers, Rx for the temporary relief of cough. Recall #D-014-8. CODE Lot numbers: RD6219, RF6266, RF6305, RF6306, RF6307, RJ6419, RJ6476, RJ6477, RJ6478, RK6524, RK6525, RK6526, RK6527, RL6621, RL6622, RN6710, VS5831, RL6817, RL6818. MANUFACTURER Alpharma, U.S. Pharmaceuticals Division, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated September 9, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Firm estimated that 24,412 units remained in commerce at time of recall initiation. REASON Subpotent for codeine phosphate at 18 month stability test point. _______________ PRODUCT OTC vitamin/amino acids/mineral products: a) Plex in 20 ounce containers; b) Kids Plex Jr, in 16 ounce containers. Recall #D-015/016-8. CODE Lot numbers: a) 97144; b) 97419, 97148, 97128, 97077. MANUFACTURER Natureade, Inc., Paramount, California. RECALLED BY Performance Nutrition, Division of Naturade, Inc., Dallas, Texas, by letter September 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY a) 2,205 units; b) 16,749 units were distributed. REASON Product insert makes unapproved drug claims related to attention deficit hyperactivity disorder. _______________ PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin, USP), 0.3 mg, in bottles of 100, indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Recall #D-018-8. CODE Lot #04446F EXP 3/98. MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico. RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by letter on September 18, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 24,846 bottles were distributed. REASON Assay failure at 15 month stability test. -9- _______________ PRODUCT Liquid Oxygen, USP, Cryogenic Dewar, Rx. Recall #D-019-8. CODE Lot #F10H1778. MANUFACTURER Jimmie Jones Sooner Airgas, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on July 10, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Yellowish brown discharge from transfilling hose. _______________ PRODUCT Orudis KT Caplets (Ketoprofen), 12.5 mg in bottles of 30 Caplets and Siderack/Floorstand Displays containing 4 dozen 30's, OTC product, indicated for the temporary relief of minor aches and pains. Recall #D-022-8. CODE Lot 6XG288 (bottles) and 2716, 3016 (case for lot 6XG288). MANUFACTURER Whitehall Robins Laboratories, Guayama, Puerto Rico. RECALLED BY Whitehall-Robins Healthcare, Madison, New Jersey, by letter on September 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 43,740 bottles were distributed; firm estimated that 4,000 bottles remained on market at time of recall initiation. REASON Content uniformity failure. _______________ PRODUCT Oxygen USP, in aluminum "D" size high pressure cylinders. Recall #D-023-8. CODE All lots remaining in expiry date. MANUFACTURER Valley Medical Equipment and Supply, Inc., Star City, West Virginia. RECALLED BY Manufacturer, by visit. Firm-initiated recall ongoing. DISTRIBUTION West Virginia and Pennsylvania. QUANTITY Approximately 20 cylinders were distributed. REASON Current good manufacturing practice deviations. Failure to document assay results. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT Source Plasma. Recall #B-876-7. CODE Unit numbers: HVM507, HVM537, HVM562, HVM592. MANUFACTURER Plasma Services of Montana, Billings, Montana. -10- RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 30, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 4 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type I (anti-HIV-1), but were collected from a donor who previously tested Western blot indeterminate. _______________ PRODUCT a) Platelets, Pheresis; b) Platelets Pheresis Irradiated; c) Fresh Frozen Plasma. Recall #B-1307/1309-7. CODE Unit numbers: a) 21 P68820, 21 P68092; b) 21 P68820, 21 P68092; c) 21 P68820. MANUFACTURER American Red Cross Blood, Portland, Oregon. RECALLED BY Manufacturer, by letter on May 28, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon and Washington state. QUANTITY a) 2 units; b) 2 units; c) 1 unit was distributed. REASON Blood products were collected from a donor who received an accidental needle stick. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1340/1341-7. CODE Unit #28LG00655. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY Manufacturer, by letter on April 18, 1997, and telephone on April 22, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY 1 unit was of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1342/1343-7. CODE Unit #28LE17742. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY Manufacturer, by telephone on April 17, 1997, and by letter on April 18, 1997. Firm-initiated recall complete. DISTRIBUTION South Carolina and Georgia. QUANTITY 1 unit of each component was distributed. -11- REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1362/1365-7. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Topeka Blood Bank, Inc., doing business as Kansas Blood Services, Topeka, Kansas. RECALLED BY Manufacturer, by telephone and letter on June 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Arkansas, California, Florida, Georgia, Kansas, Missouri. QUANTITY a) 285 units; b) 41 units; c) 110 units; d) 159 units were distributed. REASON Blood products were collected from donors in which infectious disease testing (HIV antigen, anti-HIV 1/2) was performed improperly. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1369/1370-7. CODE Unit #16047-7379. MANUFACTURER Blood Systems, Inc., Jackson, Mississippi. RECALLED BY Manufacturer, by letter dated June 28, 1995. Firm-initiated recall complete. DISTRIBUTION Mississippi and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT Red Blood Cells. Recall #B-1354-7. CODE Unit #22GE38444. MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on January 15, 1997. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product tested positive for the C antigen was labeled as negative. _______________ PRODUCT Red Blood Cells. Recall #B-1379-7. CODE Unit #16LY27294. -12- MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on June 18, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product tested positive for anti-CMV was labeled as CMV negative. _______________ PRODUCT Red Blood Cells. Recall #B-055-8. CODE Unit #4799158. MANUFACTURER BloodCare, Dallas, Texas. RECALLED BY Manufacturer, by telephone on April 10, 1997, followed by letter dated May 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Platelets. Recall #B-056-8. CODE Unit 21364-6125. MANUFACTURER United Blood Services, Fargo, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 19, 1997. Firm- initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Red Blood Cells. Recall #B-057-8. CODE Unit #21360-6577. MANUFACTURER United Blood Services, Fargo, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 25, 1996. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Blood product remained at room temperature for an unacceptable length of time. _______________ PRODUCT Red Blood Cells. Recall #B-058-8. CODE Unit numbers: 21364-7128, 21364-7134, 21364-6053, 21364-6054, 21364-6057, 21364-7124. -13- MANUFACTURER United Blood Services, Fargo, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 1 and 24, 1997. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 6 units were distributed. REASON Blood products were exposed to unacceptable temperatures during shipment. ____________ PRODUCT Fresh Frozen Plasma. Recall #B-059-8. CODE Unit numbers: 10515-0057 and 10515-0060 MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 15, 1996. Firm- initiated recall complete. DISTRIBUTION Arizona. QUANTITY 2 units were distributed. REASON Blood products were prepared from units of Whole Blood with extended collection times. ______________ PRODUCT Red Blood Cells. Recall #B-060-8. CODE Unit numbers: 10521-0414, 10521-1162. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 1, 1996, followed by letter dated January 2, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 2 units were distributed. REASON Blood products remained at room temperature for an unacceptable length of time. _______________ PRODUCT Red Blood Cells. Recall #B-061-8. CODE Unit #29445-8892. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on July 30, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product remained at room temperature for an unacceptable length of time. _______________ PRODUCT Platelets. Recall #B-067-8. CODE Unit #22KZ13545. MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on March 19, 1997. Firm-initiated recall complete. -14- DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product which tested positive for anti-Lea, was distributed labeled as negative for unexpected antibodies. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT AirCare Source Control Airator. Recall #Z-910-7. CODE Serial numbers 000085 through 000298. MANUFACTURER Industrial Molding Corporation, Lubbock, Texas. RECALLED BY Apotheus Laboratories, Ltd., Lubbock, Texas, by telephone on July 21, 1997, by fax on July 22, 1997, followed by letter dated July 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Florida, Illinois, Louisiana, Kentucky, Kansas, Pennsylvania, Texas. QUANTITY 213 units were distributed. REASON seven units were found to have Primary Inspiratory Relief (PIR) Valves that stuck; two of the devices were also found to have stuck Inspiratory Negative Pressure Relief Valves. _______________ PRODUCT Cell-Dyn 3500 Software, Revision G or H used in Cell-Dyn 3500 CS Hematology Analyzer and Cell-Dyn 3500SL Hematology Analyzer. Recall #Z-021/022-8. CODE List Nos: 03H69-01, 04H41-01, 91340-01, 91340-03, 91350-01, 91350-03. MANUFACTURER Abbott Diagnostics Division, Santa Clara, California. RECALLED BY Manufacturer, by letter sent beginning September 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 3,938 kits were distributed. REASON When using the Cell-Dyn 3500 Software, Revision G or H, specimens run in the Auxiliary Mode can recover white blood cells (WBC) results higher than expected. _______________ PRODUCT Cardiolife Defibrillator, used to restore normal heart rhythms: a) Model TEC-8250A; b) Model TEC-8251A. Recall #Z-023/024-8. CODE a) Units shipped from 7/21/92 - 8/18/94; b) Units shipped from 6/22/92 -3/13/96. -15- MANUFACTURER Nihon Kohden Corporation, Ohsato-Gun, Saitama- Ken, Japan. RECALLED BY Nihon Kohden American, Inc., Irvine, California, by telephone followed by letter on August 12, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 134 units were distributed. REASON If the battery is used beyond the recommended life cycle, the battery may develop an internal short circuit, thereby creating an excessive current flow in the charging circuit of the defibrillator which could render the defibrillator inoperable until appropriate repairs can be made. _______________ PRODUCT Vigilance brand Continuous Cardiac Output/Oximetry (CCO/Sv02) Monitor, with drug calculation mode to calculate infusion rates, Product Code 74 DYG. Recall Z-031-8. CODE Various serial numbers. MANUFACTURER Baxter Healthcare Corporation, Cardio Vascular Group (CVG), Irvine, California. RECALLED BY Manufacturer, by letter dated September 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Japan. QUANTITY 312 units were distributed. REASON An inherent software coding error, when combined with a data entry of the patients weight in pounds, will result in an infusion rate 2.2 times greater than the correct calculation. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT AMS Sphincter 800/Securo-T Urinary Prosthesis Accessory Kit, Part Number 72401685, used to treat urinary incontinence caused by intrinsic sphincter deficiency (ISD). Recall #Z-019-8. CODE The lot number of the recalled accessory kits begins with DE157, and is followed by three additional digits which vary and indicate the number of each unit. MANUFACTURER American Medical Systems, Inc., Pfizer Medical Technology Group, Minnetonka, Minnesota. RECALLED BY Manufacturer, by letter on October 9, 1997. Firm-initiated field correction ongoing. DISTRIBUTION California, Massachusetts, Minnesota, Missouri, North Carolina, Pennsylvania, Texas, and Utah. QUANTITY 18 units were distributed. -16- REASON A package insert for another product was put in the product packages. _______________ PRODUCT Various sterile devices for surgical use: a) EYE SPEARS (Ophthalmic Sponges)- packed in pouches of 2, 5 and 10. Sold in cases of 100/case and 200/case b) NEUROLOGICAL SPONGES - various sizes, packed in pouches of 10, sold in cases of 200/case c) COTTON BALLS - various sizes, packed in pouches of 5, sold in cases of 250/case. Recall #Z-025/027-8. CODE All lots, all catalog numbers. MANUFACTURER AMD-RITMED, Inc., Buffalo, New York. RECALLED BY Manufacturer, by letter dated September 12, 1997. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY All sterile product currently in the marketplace. The firm sells approximately 220 cases per month. REASON The directions for use claim the devices are ETO sterilized when in fact they are gamma irradiated. -17- END OF ENFORCEMENT REPORT FOR OCTOBER 29, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for