September 27, 2000 00-39RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Craigellachie Smoked Scottish Salmon; Codes, vacuum packed, net weight 4 ounces. Recall #F-899-0. CODE "3966". MANUFACTURER Grants Smoked Foods, Ltd., Cumbria United Kingdom. RECALLED BY Beyer Lightning Fish Company, Inc., New York, New York, by letter dated March 27, 2000. The New York State Agriculture Commissioner iss ued a press release on March 24, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Maine. QUANTITY 5 cases (75 packages per case) were distributed. REASON Product is contaminated with Listeria monocytogenes. _________ PRODUCT a) Nature’s Wonderland Virginia Snake Root, Cut, in 1-ounce, 4-ounce and 16-ounce packages; b) Nature’s Wonderland Virginia Snake Root Capsules, 625 mg, in bottles of 50. Recall #F-901/902-0. CODE Item #433, Lot Numbers: OR112086, HB121696, OR092297. MANUFACTURER Penn Herb Company, Ltd., Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter mailed on July 29, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Products contained aristolochic acid, a potent carcinogen and nephrotoxin. ________ PRODUCT Deli Quick Takes brand New York Style Potato Salad, in 16- ounce and 32-ounce plastic containers. Recall #F-903-0. CODE USE BY AUG 26. MANUFACTURER Publix Super Markets Deli Salad Operation, Lakeland, Florida. RECALLED BY Publix Super Markets, Inc., Lakeland, Florida, by press release on August 21, 2000, and by E-mail on August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Florida, South Carolina, Georgia, Alabama. QUANTITY 45,456 pounds were distributed. REASON Product was contaminated with Salmonella. ________ PRODUCT a) CTF brand Pickled Eggplant in 16-ounce glass jars; b) Asian Boy brand Pickled Eggplant, in 16-ounce glass jars. Recall #F-905/906-0. CODE None. MANUFACTURER a) Combined Thai Foods, Company, Ltd., Bangkok, Thailand; b) Minh Nguyet Company, Ho Chi Minh, Vietnam. RECALLED BY BCN Trading Corporation, Brooklyn, New York, by letter dated January 28, 2000, and by allergen alerts on January 26, 2000. Firm-initiated recall complete. DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, New Jersey, Georgia, Florida, Maryland, District of Columbia. QUANTITY a) 18 cases (24 jars per case); b) 172 cases (24 jars per case) were distributed. REASON New York State Department of Agriculture and Markets (NYSDAM) analysis of the products found that they contained undeclared sulfites. ________ PRODUCT Wang Derm brand Sour Bamboo Shoot, in 32-ounce (2 pound) plastic jars. Recall #F-907-0. CODE None. MANUFACTURER Wang Derm Exporter, Bangkok, Thailand. RECALLED BY Vasinee Food Corporation, Brooklyn, New York, by press release on April 11, 2000, and by letter dated April 13, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Connecticut. QUANTITY 200 cases (12 jars per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Bodacious Geraldine's Key Lime Bites, cookies, in 5.5-ounce boxes. Recall #F-910-0. CODE All codes manufactured from October 1998 to July 2000. The product does contain a date stamped on the box which is the expiration date (nine months from bake date). The inside bag is stamped with product initials (Key Lime = KL), date of production = letter corresponds to month (A = Jan), and two number year (199 = 99). MANUFACTURER The Bodacious Food Company, Jasper, Georgia. RECALLED BY Manufacturer, by telephone, fax and letter on June 22, 2000, and by press release on August 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Florida, Georgia, South Carolina, Louisiana, Maryland, North Carolina, Ohio, Tennessee, Wisconsin. QUANTITY Undetermined. REASON Product contains undeclared egg.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Hazer Baba Genuine Turkish Delight, with Walnut packaged in 454 g (16- ounce) cardboard box. Recall #F-846-0. CODE None. MANUFACTURER Hazer Baba Gida San Ltd. STI, Istanbul, Turkey. RECALLED BY Transmideast Shipping & Trading Agency, Inc., Brooklyn, New York, by telephone on April 12, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. QUANTITY Firm estimates none remains on the market. REASON Product contained the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT Sycamore Farms Low Fat Recipe Ready to Eat Chicken Salad Complete Lunch Kit, net weight 3-1/2 ounce box. Recall #F-900-0. CODE All lunch kits manufactured since 7/17/00, packaged with chicken salad can codes D199, D200, D206, D208, D213, D215, D220, D221, D227, D236, D241. There are no lot numbers present on the lunch kits. MANUFACTURER The Suter Company, Inc., Sycamore, Illinois. RECALLED BY Manufacturer, by telephone on September 1, 2000, and by press release on September 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 904,872 kits were distributed. REASON The product contains undeclared whey protein concentrate, polydextrose, natural flavor, sodium benzoate, potassium sorbate, phosphoric acid, onion powder, lactic acid, garlic powder, and spice extractives. ________ PRODUCT Lay's brand Classic Potato Chips, net weight 5-1/2 ounces. Recall #F- 904-0. CODE AUG22 52721890671. MANUFACTURER Frito-Lay, Inc., Rosenberg, Texas. RECALLED BY Frito-Lay, Inc., Plano, Texas, by E-mail on July 19, 2000. Firm- initiated recall complete. DISTRIBUTION Texas. QUANTITY 504 units. REASON Bags labeled as "Classic Potato Chips" actually contain "Sour Cream and Onion Potato Chips." The "Sour Cream and Onion Potato Chips" contain dairy ingredients which are not listed on the "Classic Potato Chip" product’s label. ________ PRODUCT Ahi Tuna Loins, grade 2, chilled in styro cartons. Recall #F-909-0. CODE None. MANUFACTURER Race Street Foods, Inc., San Jose, California. RECALLED BY Manufacturer, by telephone on August 11, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 74 pounds were distributed. REASON Product contained elevated levels of histamine and was associated with histamine poisoning. ________ PRODUCT Doritos Toasted Corn Chips, 14.5 ounces. Recall #F-911-0. CODE Sep26 1273206. MANUFACTURER Frito-Lay, Inc., Rosenberg, Texas. RECALLED BY Frito-Lay, Inc., Plano, Texas, by E-mail on August 18, 2000. Firm- initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 3,300 packages were distributed. REASON The product, labeled as Doritos Toasted Corn Chips, actually contains Cooler Ranch Corn Chips. The Cooler Ranch product contains dairy ingredients, a soy ingredient, FD&C Yellow No. 5, FD&C Red No. 40, and FD&C Blue No. 1 which are not listed as ingredients on the Doritos product.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Glucose Tolerance Test Beverage, (Carbonate), Cola, Lemon Sour, and Orange Flavors, 100 gms D-Glucose, in 10-fluid ounce bottles, under the brand Qualadex, OTC used as a diagnostic test solution for diabetes testing. Recall #D-191-0. CODE All lots manufactured on or after August 1999. MANUFACTURER Irenda Corporation, Los Angeles, California (contract manufacturer) RECALLED BY Breen Labs, Los Angeles, California (responsible firm/distributor), by letter on July 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 44,231 bottles were distributed. REASON Sub-potency. ________ PRODUCT Carbamazepine Tablets, 200 mg, Rx. NDC #51655-428-26. Recall #D-470-0. CODE Lot #S302QJ EXP 10/31/01. REPACKER Pharmaceutical Corporation of America, Carmel, Indiana. RECALLED BY Repacker, by notifying the V.A. to return the goods on November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 4,532 bottles were distributed; firm estimates none remains on the market. REASON Label mix-up - A portion of the lot was labeled as tetracycline 500 mg. ________ PRODUCT 649 various Rx and OTC products. Recall #D-471-0. CODE All products and package sizes bearing a PCA (Pharmaceutical Corporation of America) label except those with a lot number ending in RA, RB, or RC. REPACKER Pharmaceutical Corporation of America, Carmel, Indiana. RECALLED BY Repacker, by letter on March 13, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 3,846,600 bottles were distributed. REASON Current good manufacturing deviations, including but not limited to lack of control to prevent beta-lactam antibiotic cross contamination. ______ UPDATE Recall #D-390-0 which appeared in the May 31, 2000 Enforcement Report has been extended as follows: Promethazine Syrup Plain, Rx, 6.25 mg/5 mL, 4 and 16 oz bottles, to include Lot 22086 as sub-lots A,C,E Lot 22148 as sub-lots A,C,E,F, H Lot 22345 as sub-lots A,C,E, F Lot 22481 as sub-lots A,C Lot 22623 as sub-lots A,C,E,F, H Lot 22806 as sub-lots A,C,E, F Lot 23020 as sub-lots A,C, E,F,K Promethazine with Codeine Cough Syrup, Rx, (6.25mg/5mL and 10mg/5mL), in 4 fl. oz. bottles to include Lot 22649A.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Homatropine Hydrobromide Ophthalmic Solution, USP, 5% Dropperettes, 1 ml, Rx for treatment of itritis an diridocyclitis, for relief of cillary spasm, and also as an aid in refraction. NDC #58768-778-12. Recall #D-469-0. CODE Lot Numbers and EXP Dates: W152 AUG-00, X2123 MAR-01, X2124 AUG-01, X2125 AUG-01, X2126 SEP-01, X2127 SEP-01, X2128 OCT-01, X2129 OCT-01. MANUFACTUER OMJ Pharmaceuticals (OMJ), San German, Puerto Rico. RECALLED BY Ciba Vision Ophthalmic (CVO), Duluth, Georgia (distributor of finished product, responsible for labeling text), by letter on or about September 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Puerto Rico. QUANTITY 8,229 units were distributed. REASON Potency not within USP specifications (stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets. Recall #B-1145-0. CODE Unit Numbers: 13LG61788, 13FN46316, 13LG61785. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on October 8, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 3 units were distributed. REASON Blood products were not tested for CMV antibodies, but were labeled CMV negative. ________ PRODUCT Red Blood Cells. Recall #B-1148-0. CODE Unit Numbers: 38E74764 and 38FC35905. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on June 3, 1998. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 2 units were distributed. REASON Blood products were not phenotyped for the Jka antigen were distributed for a patient with an anti-Jka. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1153/1154-0. CODE Unit Numbers: 13GZ32027 and 13GZ31389. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letters dated November 4 or 5, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1172/1173-0. CODE Unit #04M88637. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on April 21, 2000. Firm-initiated recall complete. DISTRIBUTION California and Massachusetts. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor in which arm preparation was not performed or was performed inappropriately. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1179-0. CODE Unit Numbers: 3346817 and 3348271. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone on January 22, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Red Blood Cells were leukoreduced by filtration greater than five days past the time of collection. ________ PRODUCT Red Blood Cells. Recall #B-1180-0. CODE Unit #50LJ08814. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by telephone on October 27, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving post donation information reporting a bacterial throat infection. ________ PRODUCT Platelet Pheresis, Leukocytes Reduced. Recall #B-1183-0. CODE Unit #3904531. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by fax on January 28, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product had a high white blood cell count. ________ PRODUCT Platelets, Pheresis. Recall #B-1185-0. CODE Unit #3350069. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by letter on February 25, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT Source Plasma. Recall #B-1201-0. CODE Unit Numbers: N-70388-036, G-13893-036, G-14625-036, G-15087-036, G- 15554-036, G-15888-036, G-16657-036, G-16946-036, G-17594-036, G-17902- 036, G-18587-036, G-50936-036, G-51476-036, G-51856-036, G-52442-036, G- 52658-036, G-53261-036, G-53486-036, G-54188-036, G-54522-036, G-54908- 036, G-55238-036, G-28423-036, G-28618-036, G-29399-036, G-62905-036, G- 29637-036, G-30356-036. MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California. RECALLED BY Manufacturer, by letter dated February 4, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee, New Jersey, Germany, Italy. QUANTITY 28 units were distributed. REASON Blood products tested negative for anti-HIV-1/2, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2. ________ PRODUCT Red Blood Cells. Recall #B-1204-0. CODE Unit #12FN46389. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer telephone on March 15, 1999, followed by letter dated March 26, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product which tested repeatedly reactive for HBsAg was subjected to additional duplicate retesting and distributed. ________ PRODUCT Platelets. Recall #B-1205-0. CODE Unit #7987888. MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida. RECALLED BY Manufacturer, by telephone on July 22, 1999, followed by letter dated July 26, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product tested negative for anti-HIV-1, but was collected from a donor who previously tested repeatedly reactive for anti-HIV. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1206/1208-0. CODE Unit Numbers: 7158951 and 7155675. MANUFACTURER Carter BloodCare, Bedford, Texas. RECALLED BY Manufacturer, by letter dated December 8, 1999, and April 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas and California. QUANTITY 2 units were distributed. REASON Blood products tested negative for anti-HIV-1, but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Platelets. Recall #B-1181-0. CODE Unit #13FN48766. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated February 25, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with a discrepant collection time. ________ PRODUCT Red Blood Cells. Recall #B-1202-0. CODE Unit #7944019. MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, Florida. RECALLED BY Manufacturer, by telephone on March 11, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a tissue transplant (surgery) within a year of donation. ________ PRODUCT Platelets, Pheresis. Recall #B-1209-0. CODE Unit Numbers: 8123963 and 8123964 (split unit). MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida. RECALLED BY Manufacturer, by telephone on June 23, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products were stored at unacceptable temperatures.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Endopouch Pro Specimen Retrieval Bag, Model PRO46. Recall #Z-910-0. CODE All products produced from original release -- October 2,1998 until the application and release of overlabeled batches on March 1, 1999: 1810512, 1810543, 1810544, 1810545, 1810551, 1810552, 1811501, 1811502, 1811503, 1811504, 1811505, 1811522, 1811523, 1811524, 1811525, 1811526, 1811529, 1811530, 1811531, 1811532, 1811533, 1811544, 1811545, 1811546, 1811547, 1811548, 1811549, 1811550, 1811551, 1811552, 1811553, 1812520, 1812521, 1812522, 1812523, 1812524, 1812525, 1812526, 1812527, 1812528, 1812529, 1812565, 1812566, 1812567, 1901504, 1901505, 1901506, 1901507, 1901508, 1901509, 1901510, 1901541, 1901542, 1901543, 1901544, 1901545, 1901546, 1901547, 1901548, 1901549, 1901550, 1901561, 1902515, 1902516, 1902517, 1902518, 1902519, 1902520, 1902521, 1902536, 1902537, 1902538, 1902539, 1902540, 1902541, 1902542, 1902543, 1902544, 1902545, 1902546, 1902547, 1902548, 1902549, 1902550 MANUFACTURER Ethicon, Inc., Somerville, New Jersey. RECALLED BY Manufacturer, by conducting In-service education program beginning in January of 1999 and was completed in April of 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 33,030 units were distributed. REASON Breakage of the metal rim, bags not sealing, and bag breakage. ________ PRODUCT ImmunoCard Rotavirus, an ELISA diagnostic test kit for the detection of Rotavirus antigens in human stool. Recall #Z-949-0. CODE Lot Numbers: 708030.139 EXP 1/10/01; 708030.140 EXP 1/10/01; 708030.141 EXP 1/10/01; 708030.145 EXP 4/24/01. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter telephone, telephone and fax on June 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 516 kits were distributed. REASON The conjugate concentration is too high resulting in false positive test results. ________ PRODUCT Becton Dickinson Exacta Percutaneous Sheath Introducer Kits, for the introduction or insertion of pulmonary arterial catheters into the vascular system: a) KIT-012-00; b) KIT-009-01; c) KIT-010-00; d) KIT-012-00; e) KIT-009- 00. Recall #Z-954/958-0. CODE Lot Numbers: a) F52529; b) F51169; c) F51209; d) F52539; e) F51159. MANUFACTURER Becton Dickinson Critical Care Systems PTE Ltd., Singapore. RECALLED BY Becton Dickinson Infusion Therapy Systems, Inc., Sandy, Utah, by letter on July 11, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, California, Colorado, Illinois, Indiana, Louisiana, Minnesota, New Jersey, Ohio, Tennessee, Utah. QUANTITY 349 kits were distributed. REASON Introducer kits contain Clinipad components labeled as sterile. ________ PRODUCT Compat Specialty Feeding Tubes 22 French CALUSO PEG Deluxe Tube Kits, Product Number 097022 Compat Specialty Feeding Tubes 22 French NUPORT PEG Deluxe Tube Kits, Product Number 097522 Compat Specialty Feeding Tubes 15 French PEDI PEG Deluxe Tube Kits, Product Number 084015 For distribution in Europe, the products are: Compat PEG 22 French Reference Number 052001 (the equivalent to the 22 French CALUSO PEG in the kit distributed in the U.S.) Compat NUPORT-PEG 22 French, Reference Number 052005 (this is equivalent to the 22 French NUPORT PEG in the kit distributed in the U.S.) Compat PEG 15 French, Reference Number 052000 (this is equivalent to the 15 French PEDI PEG in the kit distributed in the U.S.). The PEG's in the European and U.S. kits are the same, but some of the other components in the kits are different. The PEG tubes are percutanous endoscopic gastrostomy devices intended to provide gastric access portals for the administration of enteral feeding formulas. Recall #Z-959/961-0. CODE Lot Numbers: Product # 097522 - NUPORT PEG U.S. label Lots 1669NX, 2679NX, 3099NX, 3519NX, 0350NX, 0560NX, 0910NX, 1220NX, and 1530NX Product # 097022 – CALUSO PEG U.S. label Lots 2679MX, 3089MX, 0210MX, 0560MX, 1220MX, and 1530MX Product # 084015 – PEDI PEG U.S. label Lots 2679KX, 3339KX, 0680KX, and 1530KX Product # 052005 – NUPORT PEG E.U. label Lots 2439RX, 2679RX, 3239RX, and 0350RX Product # 052001-22 French PEG E.U. label Lots 2439SX, 2929SX, and 3509SX Product # 052000 – 15 French PEG E.U. label lots 1669QX, 2679QX, 3169QX, 0140QX, 0140QXA, and 0700QX E.U. = European Label; U.S. = Domestic Label. MANUFACTURER Enthox Corporation, Buffalo, New York. RECALLED BY Novartis Nutrition Corporation, St. Louis Park, Minnesota, by letter on July 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Germany, India, Taiwan. QUANTITY 14,000 kits were distributed. REASON Gastrostomy tube can separate from dilator tube during placement. ________ PRODUCT Non-rechargeable lithium battery for use with the LIFEPAK 500 Automate External Defibrillator. LP 500 is designed to be used by first responders to cardiac emergencies, including fire and police personnel. The LP500 is also used by trained personnel on commercial airlines. Recall #Z-962-0. CODE Part numbers 3005380-000 through -006 (with date codes of 9837 through 9920) and part number 3005380-014 (with date codes of 9812 or 9901 through 9905). MANUFACTURER Medtronic Physio-Control Corporation, Redmond, Washington. RECALLED BY Manufacturer, by letter on July 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY United States - 8587; International 1115; Physio-Control field units 106 REASON Battery failure due to battery cell rupture causing battery pack case to split. ________ PRODUCT Premier Rubeola IgG ELISA, an in-vitro diagnostic test kit for the qualitative detection of IgG Antibody to Rubeola Virus in Human Serum. Recall #Z-964-0. CODE Catalog #RBE100, Lot #RBE100.002 EXP 3/9/01. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated July 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Connecticut, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New York, Ohio, Pennsylvania, Utah, Washington, Texas. QUANTITY 163 kits were distributed. REASON Reference control does not meet specs, and may lead to false negative results. ________ PRODUCT Angiography Drape Pack, Advantec-MLD Angiography Procedure System: a) Product 500501; b) Product 500502; c) Product 500503; d) Product 500504; e) Product 500505; f) Product 500506; g) Product 500507; h) Product 500508; i) Product 500509; j) Product 500502A; k) Product 500502B l) Product 500504A; m) Product 500504B. Recall #Z-965/977-0. CODE Lot Numbers: a) 99078690; b) 99078691; c) 99148152; d) 99078700; e) 99078645; f) 99085570; g) 99151350; h) 99169036, 99161443, 99148929; i) 99169651, 99169652, 99165230, 99163788, 99163794, 99154914, 99153359; j) 99154219, 99147031; k) 99163787; l) 99147730, 99129092; m) 99161442 . MANUFACTURER Maxxim Medical, Inc., Athens, Texas. RECALLED BY Manufacturer, by letter dated June 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,107 were distributed. REASON Particulate mater may be present. ________ PRODUCT a) BBL Crystal(tm) Gram-Positive ID System, Catalog #245140 (for export only) and 245240, a miniaturized identification method for ID of aerobic gram positive bacteria; b) BBL Crystal(tm) Neisseria/Haemophilus ID Systems, Catalog #245130, a miniaturized identification method for ID of Neisseria, Haemophilus, and other fastidious bacteria. Recall #Z-981/982-0. CODE Lot Numbers: a) 0343150, 9354154, 0010168 and 0017152, EXP 1/1/2001; b) 9344151, EXP 1/1/2002. MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland. RECALLED BY Manufacturer, by letter on July 12 and 19, 2000, and by fax on July 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 1,252 kits; b) 449 kits were distributed. REASON Microbiological IVD tests misidentified bacteria in samples. ________ PRODUCT Diaphragm Assembly consisting of a silicone rubber balloon, a polypropylene stem, and polypropylene ring. The ring secures the balloon to the stem. The diaphragm assembly is a sub-component of an exhalation valve, which is designed for use with ventilators to regulate gas flow. Exhalation valves are used to prevent inspired gases from escaping through the passage that will be made available to expired gas via an inflatable balloon. Re-breathing of the expired gases is prevented by the balloon action. Recall #Z-983-0. CODE Part #BE115-2A, Lot #D1102399. MANUFACTURER Instrumentation Industries, Inc., Bethel Park, Pennsylvania. RECALLED BY Manufacturer, by letter dated July 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Connecticut, Colorado, Minnesota, Missouri, Virginia. QUANTITY 1,623 units were distributed. REASON The rings used in the diaphragm assembly were inadvertently molded with the wrong core pin. ________ PRODUCT SERADYN Color Slide Rubella 100 Test Kit, Product Number 0371005, 100 Test, a rapid latex particle agglutination test for the qualitative and semi-quantitative determination of IgG and IgM antibodies to Rubella virus in serum. Recall #Z-984-0. CODE Lot number 113239, EXP 11/09/2000. MANUFACTURER Alexon-Trend, Inc., Ramsey, Minnesota. RECALLED BY Manufacturer, by telephone on July 12, 2000, followed by letter dated July 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and The United Kingdom. QUANTITY 263 kits were distributed. REASON Positive controls do not meet specifications in 3-month stability testing. ________ PRODUCT Pulsatron II Disposable Nerve Locator, Catalog # 82-62105 This is a battery operated disposable nerve stimulator/locator intended to stimulate moto nerves exposed during surgery for the purpose of identification or location. Recall #Z-985-0. CODE All lots marketed since December 1998 with the following lot numbers: 7/27/00 Lot Numbers 16167200 16308800 16433800 16489800 16588700 16588800 16588900 16589000 16589100 16589200 16589300 16589400 16739700 16739800 16739900 17050500 17050600 17050700 17128800 17128900 17129000 17333300 17333400 17333500 17364300 17364400 17465800 17465900 17466000 17597000 17597100 17597200 17765600 17765700 17765800 18013900 18102300 18134200 18167200 18167400 18264100 18264300 18264400 18415100 18445300 18486700 18492300 18523600 18537400 18543100 18547300 18552100 18555900 18565200 18572700 18581000 18584300 18593900 18603600 18613000 18616900 18624300 18633100 18641700 18649900 18655900 18661800 18664400 18669200 18681600 18689000 18698200 18709200 18722000 18750000 18756200 18764200 18778500 18792300 18802000 18810200 18813100 18822500 18828000 18841700 18851200 18861500 18876100 18883700 18891300 18902900 18912800 18924000 18937400 18948500 18968600 18991600 19009200 19016600 19028400 19061900 19081200 19100300 19120200 19133800 19145200 19152400 19165000 19184100 19191100 19199900 19211700 19217900 19223700 19231800 19239700 19249500 19273400 19290400 19332600 19344700 19355700 19366500 19378900 19388200 19394900 19405600 19469200 19478700 19489300 19493800 19503400 19514400 19520900 19530400 19543700 19556500 19563600 19577100 19588200 19596000 19607200 19615100 19630800 19643200 19650100 19655200 19681600 19692100 19705700 19711200 19720400 19729100 19748300 19758000 19771100 19782400 19802800 19810400 19820000 19839500 19850400 19867100. MANUFACTURER Xomed, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by letter on June 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 3,042 boxes of 10 units each or 30,420 devices were distributed. REASON Failure to function or intermittent function during use. ________ PRODUCT a) Electroscope ES-0001 (1/2") Scissors Insert.Electroscope; b) ES-0002 (3/4") Scissors Insert Reusable scissors inserts, part of Electroscope's AEM System, which consists of a monitoring device, interconnecting cords and adapters, and electrosurgical instruments with integrated shield. Instrument inserts of various tip styles are available, including the 1/2" and 3/4" reusable scissors. Recall #Z-987/988-0. CODE Catalog Numbers: a) ES0001, Lot FC b) ES0002, Lot FC. MANUFACTURER Encision, Inc., Boulder, Colorado. RECALLED BY Manufacturer, by telephone on June 28-30, 2000, followed by fax. Firm- initiated recall complete. DISTRIBUTION California, Colorado, Georgia, Illinois, Louisiana, Maryland, Minnesota, Missouri, Mississippi, Oklahoma, Oregon, Texas, Washington state. QUANTITY 49 units were distributed, REASON Scissors inserts for electrosurgical instrument could come apart during use. ________ PRODUCT InnerDyne, Inc., One-Step Percutaneous Dilator with Sheath, intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and opertative procedures. Recall #Z-989-0. CODE Part Number OS101012, Lot JD19293. MANUFACTURER InnerDyne, Inc., Salt Lake City, Utah. RECALLED BY Manufacturer, by letter July 6, 2000, followed by visit. Firm-initiated recall complete. DISTRIBUTION Arizona, California, Florida, Illinois, Massachusetts, New York, Virginia, Wyoming. QUANTITY 174 units were distributed. REASON Compromised sterile barrier on the lid-stock of sealed product trays. ________ PRODUCT Otto Bock Modular Knee Joints, Model 3R36, used for lower limb amputees up to 220 pounds body weight, and with moderate activity levels. Recall #Z-990-0. CODE Batch 0150. MANUFACTURER Otto Bock Orthopedische Industrie, Duderstadt, Germany. RECALLED BY Otto Bock Orthopedic Industry, Inc., Minneapolis, Minnesota, by letter dated July 26, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Germany. QUANTITY 51 units were distributed. REASON The prosthetic knee joint could fail due to setscrews, which can come loose. ________ PRODUCT Norian Pneumatic Mixer, used in conjunction with Norian Reactant Pack by automatically preparing Reactant Pack constituent components for transfer of mixed cement paste into sterile field. a) Item #MXR-1000 Pneumatic Mixer Assembly b) Item #MXR-PNE01-UNV Pneumatic Mixer Assembly c) Item #5-MXR-1000 Pneumatic Mixer Assembly. Recall #Z-992/994-0. CODE All codes. MANUFACTURER Norian Corporation, Cupertino, California. RECALLED BY Manufacturer, by letter on August 2, 2000, followed by telephone. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 553 units were distributed. REASON The sterility of the product may be compromised as evidenced by a loss of package integrity. ________ PRODUCT Allograft Heart Valve: a) Model No. AV10; b) Model No. PV00. Recall #Z-995/996-0. CODE Serial Numbers: a) 6815324; b) 6815701. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on July 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York and Michigan. QUANTITY 2 valves were distributed. REASON Discordant serology results for Hepatitis B Core Antibody. ________ PRODUCT CryoValve Allograft, human heart valve replacement implant: a) Model No. AV05; b) Model No. PV05. Recall #Z-997/998-0. CODE Serial Numbers: a) 3997502; b) 3997529. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on July 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 2 valves were distributed. REASON Serodilution of plasma. ________ PRODUCT Customized Flextend(tm) Tracheostomy Tubes, with Standard Curve, wire reinforced distal shafts. Recall #Z-999-0. CODE All customized standard curve, wire reinforced distal shaft option tubes manufactured between January and July 2000 are under recall. The standard commercial FlexTend tracheostomy tubes, and other distal shaft options are not subject to this removal. MANUFACTURER Bivona Medical Technologies, Gary, Indiana. RECALLED BY Manufacturer, by letter dated August 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 132 units were distributed. REASON The curved, wire-reinforced distal shaft fails to remain curved. ________ PRODUCT Dialysis Reverse Osmosis Water System, a single/stand alone water treatment system used in hemodialysis applications, designed to pre-treat and purify potable water for use in making dialysate for hemodialysis: Model Numbers: MROS, MRO1, and MRO2. Recall #Z-1000/1002-0. CODE Serial Numbers: 97095 to 97220. MANUFACTURER Ameriwater, Dayton, Ohio. RECALLED BY Manufacturer, by fax on August 14, 2000, and by telephone beginning on August 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Montana, Illinois, Colorado, Tennessee, Kentucky, Nebraska, Kansas, Virginia, Massachusetts, Oklahoma, New Jersey, Texas, Pennsylvania. QUANTITY 58 devices were distributed. REASON The RO system experiences a low draw-rate of peroxide/peroxyacetic acid (PAA) during sanitization of system. ________ PRODUCT Dr. Sweat’s Atlas Orthogonal Chiropractic Adjustment Table (also known as Atas Table), used to adjust the neck of chiropractic patients. Recall #Z-1003-0. CODE Model number: WWO1100 Serial numbers: 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100138, 100139 and 100142. MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama. RECALLED BY Sweat Chiropractic Clinic, Atlanta, Georgia, by letters in August 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Japan, Quebec and Hong Kong. QUANTITY 32 units were distributed. REASON Manufacturing defect could cause patient to be pinned by stylus to adjustment table. ________ PRODUCT CryoValve Allograft, heart valve. Recall #Z-1004-0. CODE Serial Number 6802082. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on July 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio. QUANTITY 1 valve was distributed. REASON Donor possessed adenocarcinoma of the prostate. ________ PRODUCT 33-mm CardioSeal Septal Occluder Implant (Sterile), designed to close intra-aortic defects percutaneously with the assistance of a Delivery System. Recall #Z-1005-0. CODE Ref No. OCL-33-PFO Lot number: 0007403 Use Before: 2004-5. MANUFACTURER Nitinol Medical Technologies, Inc., Boston, Massachusetts. RECALLED BY Manufacturer, by telephone on July 28, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois and Virginia. QUANTITY 4 units were distributed. REASON Mislabeled as 33-mm vs 17-mm Septal Occluder Implant. ________ PRODUCT Angio-Seal Vascular Closure Device 6 French, Model 610091, for use in closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a French or smaller procedural sheath. Recall #Z-1008-0. CODE Lot #22850. MANUFACTURER Kensey Nash Corporation, Exton, Pennsylvania. RECALLED BY St. Jude Medical, Inc., Daig Division, Minnetonka, Minnesota, by letter dated August 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,100 units were distributed. REASON Device crimp stop can slip. ________ PRODUCT Immunocard H. Pylori, for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Recall #Z-1009-0. CODE Product Number: 710030 Lot Numbers #710030.093 EXP 2/20/02, #710030.095 EXP 3/8/01, #710030.096 EXP 3/8/01, and #710030.097 EXP 3/6/01. MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter, telephone and fax on August 23, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Venezuela, New Zealand, Costa Rica, Philippines, Puerto Rico, Japan, Germany, and Italy. QUANTITY 1,262 kits were distributed. REASON The test ports of the cards may exhibit false negative results. ________ PRODUCT Stryker Rugged MX-Pro Ambulance Cots, a wheeled stretcher intended for EMS use: a) Model No. 6070; b) Model No. 6080. Recall #Z-1010/1011-0. CODE All cots manufactured between May 1998 to February 1999. MANUFACTURER Stryker Medical, Kalamazoo, Michigan. RECALLED BY Manufacturer, by letters dated December 10, 1999, November 20, 1999, and June 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION United States, Bahrain, Canada, Chile, Mexico, Netherlands, Peru, South Africa, Switzerland, United Arab Emirates and United Kingdom. QUANTITY 2,154 cots were distributed. REASON The safety bar return springs located at the head end of the cots have failed. ________ PRODUCT Model Elite/Corium Laser System, various uses including dermatology, dentistry, ophthalmology, ENT, etc. Recall #Z-1020-0. CODE None. MANUFACTURER FISMA, Inc., Salt Lake City, Utah. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on September 14, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 239 units were distributed. REASON Noncompliant calibration procedures in the operator's manuals. _______ UPDATE Insyte AutoGuard IV Catheter, Recall #Z-923/936-0 which appeared in the September 13, 2000 Enforcement Report should read: DISTRIBUTION: Nationwide, Argentina, Asia Pacific, Australia, Brazil, Canada, Europe, Japan, Mexico. REASON: Localized skin irritation at catheter insertion site.MEDICAL DEVICE SAFETY ALERT=============================
_______ UPDATE The Trima Automated Blood Component Collection System manufactured and distributed by Gambro BCT, Inc., Lakewood, Colorado, which was listed under "MEDICAL DEVICE SAFETY ALERT in the 9/13/00 Enforcement Report, is NOT being recalled. The action is a firm initiated Safety Alert and consists of a letter of August 4, 2000 providing additional safety usage instructions. Each customer will also receive a revised Operator's Manual which will have emphasized instructions for the safe use of the device.END OF ENFORCEMENT REPORT FOR SEPTEMBER 27, 2000. ####
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