May 7, 1997 97-19 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Smilowitz Home Made Baking Chocolate Rugelech, net weight 1 pound (454 g), in cellophane packages. Recall #F-398-7. CODE None. EXP Date 11/28/96. MANUFACTURER Future Fortune, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by telephone and by letter dated November 5, 1996. Completed recall resulted from sample analysis and followup by New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey and New York. QUANTITY 576 packages were distributed. REASON Product contains undeclared certified colors, FD&C Yellow No. 5, Red No. 40 and Blue No. 1. _______________ PRODUCT A & S Bakery Italian Biscuits in plastic 1 pound bags. Recall #F-402-7. CODE None. MANUFACTURER Abbate, Salbatore & Victor, Brooklyn, New York. RECALLED BY Manufacturer, by visit on January 29, 1997. Completed recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 800 bags were distributed. REASON The product contains undeclared certified colors, FD&C Yellow No. 5, Red No. 40, and Blue No. 1. _______________ PRODUCT Jamaican Pride Bakery (also known as Jamaica Prestigious Bakery) "JPB Spiced Bun", net wt. 22 ounces (1 lb. 6 oz.) 624 grams. Recall #F-403-7. CODE None. MANUFACTURER Jamaican Pride Bakery, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by visit beginning January 22, 1997. Completed recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 900 packages were distributed. REASON The product contains undeclared certified colors, FD&C Yellow No. 5 and Red No. 40 _______________ PRODUCT Minute Maid Orange Juice in 16 ounce glass bottles. Recall #F-406-7. CODE Lot numbers: 6187MD, 6270MD. MANUFACTURER The Minute Maid Company, Chicago, Illinois. RECALLED BY The Minute Maid Company, Houston, Texas, by instructing customers to remove product from shelves on December 9, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 19,913 cases of lot 6187MD and 22,142 cases of lot 6270MD were distributed. REASON Product is adulterated due to the presence of glass. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Minute Maid Calcium-Rich Orange Juice in 96 ounce plastic packages. Recall #F-400-7. CODE Container MAY12PWECT349 - Shipping Case XX:XXPWEMAY12T37586A "XX:XX" is a 24 hour code. MANUFACTURER The Minute Maid Company, Paw Paw, Michigan. -2-RECALLED BY The Minute Maid Company, Houston, Texas, by telephone March 20-21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,725 cases were distributed. REASON The product is adulterated due to the presence of yeast. _______________ PRODUCT Table Syrup packed in 1.5 ounce plastic cups. Recall #F-401-7. CODE The lot #11156171J stamped on case. MANUFACTURER Portion Pak, Inc., Jacksonville, Florida. RECALLED BY Portion Pak, Inc., Mason, Ohio, by telephone on March 25, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 360 cases (100 cups per case) were distributed. REASON The product is adulterated due to the presence of mold. _______________ PRODUCT Rainbo brand, 6 Cherry Danish, packaged in 12 ounce plastic covered foil trays. Recall #F-404-7. CODE Products are coded with the sell by date, "MAR 4", "MAR 5", "MAR 6", "MAR 7", or "MAR 8" MANUFACTURER Mary Ann's Baking Co., Inc., Sacramento, California. RECALLED BY Manufacturer, by telephone on March 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 1,399 packages were distributed. REASON The product contains Undeclared certified colors, FD&C Red No. 40 and Blue No. 1. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Minocycline HCl Capsules, USP, 50 mg in bottles of 100 and 100 mg, in bottles of 50 and 1,000, used as an antimicrobial. Recall #D-122/123-7. CODE Lot numbers: 59175L EXP8/97, 59075L EXP 8/97, 58975L EXP 8/97, 10516L EXP 12/97, 10616L EXP 12/97, 10716L EXP 12/97, 10816L EXP 12/97 (50 mg); 59775L EXP 7/97, 59975L EXP 7/97, 60075L EXP 7/97, 59875L EXP 7/97, 60175L EXP 7/97 (100 mg, in bottles of 50); 137D5L EXP 12/97, 138D5L EXP 12/97. 10916L EXP 1/98 (100 capsules of 1000). -3-MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania. RECALLED BY Warner Chilcott, Rockaway, New Jersey, by letter dated February 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 34,234 bottles of 50 mg in 100 capsule bottles; 48,824 bottles of 100 mg in 50 capsule bottles; and 1,436 bottles of 100 mg in 1000 capsule bottles were distributed. REASON Bulk substance was manufactured using processes that did not conform to the firm's filed processes. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Source Plasma. Recall #B-604-7. CODE Unit numbers: 0540054846, 0540053497, 0540053141, 0540052463, 0540051050, 0540047936, 0540047520, 0540047080, 0540045688, 0540045271, 0540044224, 0540043613, 0540042491. MANUFACTURER NABI Biomedical Center, Louisville, Kentucky. RECALLED BY North American Biologicals, Inc., Boca Raton, Florida, by letter dated February 1 or 9, 1995, followed by second letters dated October 8, 1996. Firm-initiated recall complete. DISTRIBUTION France, West Germany, Italy, South Korea, Switzerland. QUANTITY 13 units were distributed. REASON Blood products were collected from a donor who reported an accidental blood exposure. _______________ PRODUCT Red Blood Cells. Recall #B-637-7. CODE Unit #36R52269. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone on January 13, 1997. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of platelets that was positive for Clostridium butyricum. _______________ PRODUCT Red Blood Cells. Recall #B-656-7. CODE Unit #18S52634. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by telephone on July 25, 1996, and by letter dated August 15, 1996. Firm-initiated recall complete. -4-DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who experienced vomiting and diarrhea at the collection site immediately following the donation and unit was inappropriately distributed. _______________ PRODUCT Platelets, Pheresis. Recall #B-657-7. CODE Unit #21P63953. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on October 29, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product had a platelet yield below the acceptable limit. _______________ PRODUCT (a) Platelets; (b) Recovered Plasma. Recall #B-658/659-7. CODE Unit #36R51047. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone followed by letter dated October 21, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with Polycythemia vera. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets (c) Plasma. Recall #B-660/662-7. CODE Unit #53R30973. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated July 16, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of hepatitis A. _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-665/666-7. CODE Unit #11J13273. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. -5-RECALLED BY Manufacturer, by telephone on or about April 3, 1996, followed by letter dated April 11, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri and Switzerland. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor whose arms showed evidence of intravenous (IV) drug use. _______________ PRODUCT Red Blood Cells. Recall #B-667-7. CODE Unit #40GK03742. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on December 2, 1996, followed by letter dated December 4, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-668/669-7. CODE Unit #49G60074. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letter dated January 16, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma and Texas. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-670-7. CODE Unit #11Y34123. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by requesting return of product on September 26, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 1 unit was distributed. REASOn Blood product corresponded to a unit of Platelets which was positive for gram positive cocci. -6-_______________ UPDATE Recall #B-560/561-7, Venoglobulin-S 5% - 50ml (2.5 grams in 50 ml) and Venoglobulin-S 5% (5.0 grams in 100 ml) which appeared in the April 23, 1997, Enforcement Report is being rescinded due to the fact that incorrect vial size were submitted on these products. The correct recall is B-562-7, Venoglobulin-S 5% - 200ml (10.0 grams in 200ml). RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Mononine Monoclonal Antibody Purified (Coagulation Factor IX, Human). Recall #B-466-7. CODE Lot #P13609 EXP 9/25/98. MANUFACTURER Centeon L.L.C., Bradley, Illinois. RECALLED BY Centeon L.L.C., A Company of Armour and Behring, King of Prussia, Pennsylvania, by telephone on February 27-28, 1997, followed by letter dated February 28, 1997. Firm-initiated recall ongoing. See also FDA Talk Paper T96-91, dated October 4, 1996. DISTRIBUTION Nationwide. QUANTITY 883 vials were distributed. REASON Biological product with lack of assurance of product sterility. _______________ PRODUCT Red Blood Cells. Recall #B-615-7. CODE Unit #12Y68093. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone on February 4, 1997, followed by letter dated February 7, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product, which may have been incorrectly typed for the C antigen, was labeled C negative. _______________ PRODUCT Recovered Plasma. Recall #B-635-7. CODE Unit #26R84884. MANUFACTURER American Red Cross, Mobile, Alabama. RECALLED BY Manufacturer, by fax on or about February 13, 1995. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. -7-_______________ PRODUCT Recovered Plasma. Recall #B-638-7. CODE Unit #36R52269. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone and fax on January 13, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of platelets that was positive for Clostridium butyricum. _______________ PRODUCT Red Blood Cells. Recall #B-663-7. CODE Unit numbers: 26146-5173, 26146-9352, 26146-9354, 26146-9494, 26146-9506, 26146-9507, 26146-9508, 26147-0755, 26147-0759, 26147-0760, 26147-0762, 26147-0764. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Fort Smith, Arkansas, by letter dated September 20, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 12 unit were distributed. REASON Unlicensed blood products were shipped interstate. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ========== _______________ PRODUCT HeartMate IP LVAS Blood Pump, Catalog #1000A, a pulsatile ventricular assist system intended for hemodynamic and circulatory support. Recall #Z-443-7. CODE All pumps manufactured between 8/1/94 and 4/30/96. MANUFACTURER Thermo Cardio Systems, Inc. (TCI), Woburn, Massachusetts. RECALLED BY Manufacturer, by visit beginning October 16, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 47 pumps. REASON The percutaneous drive line may separate from the lower housing nipple located on the blood pump. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT First Medic 710 Semi-Automatic External Defibrillator, Part #300762-01, 02, 03. Recall #Z-428-7. -8-CODE Serial numbers: 1284, 1546, 1668-1671, 1673, 1678, 1776, 1777, 1781, 1782, 1784, 1785, 1794, 1804, 1818, 1830, 1833, 1837, 1840, 1841, 1843, 1846-1849, 1851-1854, 1856-1860, 1862-1865, 1867-1882, 1884-1890, 1892-1898, 1900-1907, 1909, 1910, 1913, 1915-1918, 1920-1924, 1926-1945, 1947-1949, 1951, 1953, 1955, 1958-1964, 2065-2067, 2069-2075, 2077. MANUFACTURER Physio Control Corporation, Redmond, Washington. RECALLED BY Manufacturer, by visit beginning on March 24, 1997, followed by letter dated March 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 134 units were distributed. REASON Depressing the ON/OFF switch may result in only partial power-up and functioning of the device. Failure to completely power-up can lead to failure to defibrillate the patient. The device defect appears to be attributable to a software source code deficiency. _______________ PRODUCT Allan brand High Volume IV and Irrigation Tower, designed for hospital operating room use. Recall #Z-435-7. CODE Serial numbers: GK-001 through GK-025, and GL003, GL008, GL010, GL012, GL013, GL021, and GL022. MANUFACTURER Habco Tool and Development, Mentor, Ohio (component). RECALLED BY Allen Medical Systems, Garfield Heights, Ohio, by letter on February 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 32 units were distributed. REASON The device would drop from the raised position to the lowest position, resulting in a minor disruption of the irrigation function, and in some cases would cause the fluid bag to rupture. _______________ PRODUCT Navarre Percutaneous Access Sets and Mandrel Guidewire. Sets are intended to be used to facilitate the placement of a working guidewire for interventional radiology procedures, and are contraindicated for intravascular use: (a) Percutaneous Access Set, Model No. 610-PAS-30 (b) Percutaneous Access Set, Model No. 610-PAS-45 -9- (c) Mandrel Guidewire, Model No. 615-MGW-021. Recall #Z-449/451-7. CODE Lot Numbers: (a) 960005, 960061, 960640, 960853, 961083; (b) 960004, 960060, 960641, 960693; (c) 960471, 960778. MANUFACTURER Navarre Biomedical, Ltd., Plymouth, Minnesota. RECALLED BY Manufacturer, by letter on April 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 460 guidewires were distributed as part of the Percutaneous Access Sets or alone as Mandrel Guidewires. REASON The guidewire packaged and distributed as part of the access sets and alone is subject to breakage due to brittleness. _______________ PRODUCT SONOLINE Ultrasound Systems with OB Calculation Package Option: (a) SONOLINE Prima Ultrasound System, Part No. 5118505-LH300, All Serial Numbers (b) SONOLINE Versa Pro Ultrasound System, Part No. 4396771-LH400. Recall #Z-452/453-7. CODE All Serial Numbers. MANUFACTURER Siemens Medical Systems, Inc., Issaquah, Washington. RECALLED BY Manufacturer, by letter on March 28, 1997. Firm-initiated field correction ongoing. DISTRIBUTION (a) California, North Carolina, New York, Pennsylvania, Illinois, South Carolina, Ohio, Michigan, Virginia, New Jersey, Rhode Island, and international; (b) Nationwide and international. QUANTITY (a) 158 units; (b) 46 units were distributed. REASON A software error was discovered in the Enhanced OB Calculation of an estimated delivery date (EDC) of a fetus based on an in-vitro fertilization date. The system incorrectly calculates the EDC by an overestimation of four weeks. This software design error may lead to misdiagnosis of the fetus size. _______________ PRODUCT Oschner 200 Bifurcated Vascular Graft, Catalog No. OCW1608, used 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-455-7. CODE Lot Numbers: 40615, 40623, 40631, 40766, 40775, 40802, 41137, 41147. -10-MANUFACTURER Intervascular, Inc., Clearwater, Florida. RECALLED BY Manufacturer, by fax and certified mail on February 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and France. QUANTITY 68 grafts were distributed. REASON The water permeability of the graft may be increased, due to a weaving defect along one leg of the graft. _______________ PRODUCT VACUTAINER brand PLUS Plasma Separation Tubes (PST), evacuated blood collection tubes with an anticoagulant interior (known as Heparin) and also an interior polymer gel coating used for the collection, separation, and transport of blood specimens. Recall #Z-458-7. CODE Catalog #367960, Lot #6B516, EXP 11/96. MANUFACTURER Becton Dickinson Vacutainer Systems, Broken Bow, Nebraska. RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey, by telephone September 23-30, 1996, and by notices mailed October 22, 25, and 31, 1996. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY 116,100 units were distributed. REASON Some tubes in this lot were manufactured with an incorrect anticoagulant, K2EDTA, instead of Heparin; and the tubes were labeled as containing Lithium Heparin. _______________ PRODUCT VACUTAINER Brand Lok-On Needle Holder, a light blue color, polycarbon, reusable, non-sterile holder used with VACUTAINER Brand Blood Collection Needles during venipuncture. The needle holder is packaged 250 units in a clear plastic bag within a corrugated box. Recall #Z-463-7. CODE Catalog #366221, Lot numbers: 5M450, 5M451, 5M452, 5M453, 5M454, 5M455, 5M456, 5M457, 6A450, 6A451, 6C450, 6C451, 6C452. MANUFACTURER Becton Dickinson Vacutainer Systems, Sumpter, South Carolina. RECALLED BY Becton Dickinson Vacutainer Systems (BDVS), Franklin Lakes, New Jersey, by fax on December 9, 1996, by letters on December 3 and 19, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 52,750 units were distributed. -11-REASON The device is subject to a locking mechanism failure which can result in an uncontrolled sharp exposure to both patient and users. _______________ PRODUCT Uldall Double Lumen Hemodialysis Catheter Tray and Uldall Double Lumen Hemodialysis Exchange Trays. The catheters are intended for vascular access, distributed in Canada under the following reorder numbers: C-DDSCY-1600-26-5.0-ULDALL; C-DDSCY-1600-26-5.0-ULDALL-XCH; C-DDSCY-1600-26-7.0-ULDALL; C-DDSCY-1600-26-7.0-ULDALL-XCH; C-DDSCY-1600-28-2.5-ULDALL-XCH-RAP-031596; C-DDSCY-1600-26-2.5-ULDALL-XCH-RAP-031596; C-DDSCY-1600-26-7.0-ULDALL-XCH-RAP-031596; C-DDSCY-1600-28-2.5-ULDALL-XCH-RAP-031596. Recall #Z-469-7. CODE All lots distributed to Canada. MANUFACTURER Cook Incorporated, Bloomington, Indiana. RECALLED BY Cook Canada, A Cook Group Company, Stouffville, Ontario, Canada, by letter on February 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Canada. QUANTITY 337 catheters were distributed. REASON The labeling for the device states the lumens hold from 1.3cc to 1.6cc while the lumen is stamped as holding 2 cc which could result in a heparin overdose. _______________ UPDATE Recall #Z-347-7, Baxter Capillary Flow Dialyzer, Model CF 15 5M1709, which appeared in the April 30, 1997 Enforcement Report should read: MANUFACTURER: Baxter Healthcare Corporation, Mountain Home, Arkansas. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT ANTI-SSB Microassay, Catalog #783-260, in-vitro diagnostic test set. Recall #Z-430-7. CODE Lot #71106. MANUFACTURER Diamedix, Miami, Florida. RECALLED BY Manufacturer, by letter February 4, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 128 sets were distributed. REASON The product may be giving a higher than usual number of equivocal/low positive test results. -12-_______________ PRODUCT Ortho Brain Thromboplastin, used for prothrombin time determination, for in-vitro diagnostic use. Recall #Z-447-7. CODE Product #732400, Lot #0BT257 EXP 2/5/98. MANUFACTURER Ortho Diagnostic Systems, Raritan, New Jersey. RECALLED BY Manufacturer, by letter dated November 1, 1996. Firm-initiated recall complete. DISTRIBUTION Iowa, North Carolina, South Dakota, Oklahoma, New Jersey, Tennessee. QUANTITY 25 packages (25 vials per package) were distributed; firm estimates none remains on the market. REASON The 12 ml. vials were labeled as 20 ml. _______________ PRODUCT Microalbumin Test Kit ELISA, for the determination of microalbumin concentration in human urine 960 assays kit. Recall #Z-448-7. CODE Catalog #0700, Lot #070062. MANUFACTURER Diagnostic Specialties, Inc., Metuchen, New Jersey. RECALLED BY Manufacturer, by letter January 22, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 80 units were distributed; firm estimated that 20 units remained on market at time of recall initiation. REASON The label had an incorrect expiration date. _______________ PRODUCT VACUTAINER Brand PLUS Serum Tubes, plastic evacuated blood collection tubes with silicone-coated interior (known as SILWET L-720) and clot activator for the collection, separation, and transport of blood specimens. Recall #Z-456-7. CODE Catalog #367819, Lot #6G801, EXP Date 12/97. MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter, South Carolina. RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey, by telephone on September 3 and 9, 1996. Firm-initiated recall ongoing. DISTRIBUTION Louisiana. QUANTITY 40,000 units were distributed. REASON The tubes labeled incorrectly, an identification stripe was omitted. -13-_______________ PRODUCT VACUTAINER Brand Blood Collection Sets are sterile, disposable, single use devices used for the collection of blood samples by venipuncture. Recall #Z-457-7. CODE Catalog #007253, Lot #'s 6B081 and 6B091. MANUFACTURER NISSHO Corporation, Nipro Medical Ind. LTD, Tatebayashi, Gunma Japan. RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey, by letter September 11, 1996. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY 240,600 units were distributed. REASON The device has holes in the tubing which may result in blood leakage from the collection set or introduce air into the collection tubing. _______________ PRODUCT Proclear Daily Wear Soft Contact Lenses. Recall #Z-459-7. CODE Lot #B613317. MANUFACTURER Biocompatibles, Inc., Norfolk, Virginia. RECALLED BY Manufacturer, by telephone on October 26 and 28, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Great Britain. QUANTITY 124 lenses were distributed. REASON Some contact lenses were labeled with incorrect diopter values that did not reflect the measured value of the product. _______________ PRODUCT Ciba Vision Focus Toric Soft Contact Lenses. Recall #Z-460-7. CODE Catalog #SKU 200484, Lot #6155113. MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia. RECALLED BY Ciba Vision Corporation, Duluth, Georgia, by letter on March 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 681 6-packs were distributed. REASON The lenses were labeled with incorrect diameter values that did not reflect the measured value of the product. _______________ PRODUCT Ciba Vision Focus Toric Soft Contact Lenses. Recall #Z-461-7. CODE Catalog #SKU 200409, Lot #6184121. MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia. RECALLED BY Ciba Vision, Duluth, Georgia, by letter on or about March 24, 1997. Firm-initiated recall ongoing. -14-DISTRIBUTION Nationwide. QUANTITY 1,102 6-packs were distributed. REASON Lot integrity has been violated because some +3.00 diopter Contact Lenses were mixed in with the -1.00 diopter lenses of this lot (lot no. 6184121). _______________ PRODUCT EBV Viral Capsid Antigen IgM Elisa Test Kit, used for for the detection of IgM antibodies to Epstein-Barr viral capsid antigen and infectious monoculeosis. Recall #Z-470-7. CODE Lot #2325750-139. MANUFACTURER Wampole Labs, Division Carter-Wallace, Inc., Cranbury, New Jersey. RECALLED BY Clark Laboratories, Inc., Jamestown, New York, by letter June 26, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 190 kits were distributed. REASON The positive control was labeled with a range of 4.4 - 8.2, the correct range is 2.7 - 5.0 ISR. _______________ PRODUCT Bartels Viral Respiratory Screening and Identification Kit and Anti-Viral Antibody Identification Reagents: (a) Catalog No. B1029-86, Viral Respiratory Kit (b) Catalog No. B1029-87A, Anti-Adenovirus Antibody (c) Catalog No. B1029-87B, Anti-Influenza A Antibody (d) Catalog No. B1029-87C, Anti-Influenza B Antibody (e) Catalog No. B1029-87D, Anti-Parainfluenza 1 Antibody (f) Catalog No. B1029-87E, Anti-Parainfluenza 2 Antibody (g) Catalog No. B1029-87F, Anti-Parainfluenza 3 Antibody (h) Catalog No. B1029-87G, Anti-RSV Antibody. Recall #Z-471/478-7. CODE Lot Numbers: (a) 1338, 6H177, 6J302, 6J303, 6K329, 6M348; (b) 1075, 1075-1, 1076-1, 1076-2; (c) 1067R, 1067R-1, 6J254-1, 6K351-1, 6N157-1, 6N157-2; (d) 1068, 1068-1, 6J255-1, 6J255-2, 7A193-1; (e) 1064R, 1065-1, 1065-2; (f) 1065R, 1065R-1, 1066-1, 1066-2; (g) 1061, 1061-1, 6J256-1, 6J256-2; -15- (h) 1057R, 1057R-1, 1058-1, 1058-2. MANUFACTURER Bartels, Inc., The Diagnostics Division of Intracel, Corporation, Issaquah, Washington. RECALLED BY Manufacturer, by letter beginning April 4, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY As of 1-23-97, the following quantities had been distributed: (a) 525 units; (b) 524 units (c) 410 units; (d) 398 units (e) 279 units; (f) 219 units (g) 318 units; (h) 233 units. Firm estimated a total of 520 units remained on the market at time of recall initiation. REASON Bottles containing the anti-viral antibody identification reagents dispensed a larger drop than the manufacturing specification allows. _______________ PRODUCT Microvena Amplatz Goose-Neck Snare, a Nitinol Retrieval Device, used to retrieve foreign bodies from the cardiovascular system and hollow viscus. Recall #Z-479-7. CODE Product #GN2500, Lot #971199. MANUFACTURER Microvena Corporation, White Bear Lake, Minnesota. RECALLED BY Manufacturer, by telephone on April 7, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 39 units were distributed. REASON Some units in the recalled lot contain a 65 cm snare, instead of a 120 cm snare as labeled. _______________ PRODUCT NMC Arterial Bloodlines with reverse flow drip chamber. Recall #Z-480-7. CODE Catalog #03-7204-5, Lot #R6H095. MANUFACTURER National Medical Care, Medical Products Division, Mc Allen, Texas; and Erika De Reynosa, CD Reynosa, Mexico. RECALLED BY National Medical Care, Rockleigh, New Jersey, by telephone by August 23, 1996. Firm-initiated recall complete. DISTRIBUTION California and Missouri. QUANTITY 114 cases (24 units per case) were distributed. REASON The device drip chamber may be occluded and cause the user to be unable to prime the line. -16- END OF ENFORCEMENT REPORT FOR MAY 7, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for