September 13, 2000 00-37RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Flora brand Sun Dried Tomatoes, in 4-ounce plastic bags. Recall #F-810-0. CODE None. MANUFACTURER Flora Food Disbributors, Inc., Pompano Beach, Florida (repacker). RECALLED BY Repacker, by telephone on June 26, 2000. Completed field correction resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 1,368 bags were distributed. REASON Product contains undeclared sulfites. ________ PRODUCT Asian Boy (EBQ) brand Lotus Rootlet in Brine, in 15-ounce glass jars. Recall #F-811-0. CODE None. MANUFACTURER Mekong Company, Ho Chi Minh City, Vietman. RECALLED BY BCN Trading Corporation, Brooklyn, New York, by letter and press release on February 18, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, New Jersey, District of Columbia. QUANTITY 50 cases (24 jars per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT a) Safeway Select Rocky Road Ice Cream; b) Safeway Select Healthy Advantage Rocky Road Low Fat Ice Cream. Both products sold in half- gallon, round, paper containers. Recall #F-813/814-0. CODE Date Codes: a) 01/03/01; b) 01/02/01. MANUFACTURER Capitol Heights Ice Cream (Safeway Stores, Inc.), Capitol Heights, Maryland. RECALLED BY Safeway, Inc., Pleasanton, California, by E-mail on July 14, 2000, and by press release on July 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION District of Columbia, Maryland, Virginia, Texas, Illinois. QUANTITY 6,510 half-gallon cartons were distributed. REASON Product contains undeclared cashews, Brazil nuts and peanut oil.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Cheddar Broccoli Rice and Sauce, in 4.5-ounce packages under the Great Value and Piggly Wiggly labels. Recall #F-809-0. CODE Great Value brand: GP020401, GP020701, GP020801, GP020901, GP030801, GP032301, GP032401, GP032701, GP032801, GP040301, GP040401, GP051801, GP051901, GP052201, GP053101, GP060101, GP060501, GP060601, GP061301, GP061401, GP061501, GP062601, GP62701, GP62801, GP080301, GP080401, GP081001' Piggly Wiggly brand: T0067 and T0068. MANUFACTURER Power Packaging, Inc., Grand Prairie, Texas. RECALLED BY AC Humko, Memphis, Tennessee, by telephone on August 11, 2000, followed by fax and letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 55,447 cases (12 per case) Great Value brand and 315 cases of Piggly Wiggly brand were distributed. REASON Product contained undeclared vermicelli, a pasta containing wheat. ________ PRODUCT Wang Derm brand Sour Bamboo Shoot, in 64 ounce (4-pound) glass jars. Recall #F-812-0. CODE None. MANUFACTURER Wang Derm Exporter LP, Bangkok, Thailand. RECALLED BY Vasinee Food Corporation, Brooklyn, New York, by telephone on January 20, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Massachusetts, New York, Rhode Island. QUANTITY 200 cases (6 jars per case) were distributed. REASON Product contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Sodium Bicarbonate Injection, USP, 8.4% (84 mg/mL), for IV use only, in 50 mL single dose vial, Rx for correction of metabolic acidosis and other conditions requiring systemic alkalization. NDC #63323-006-50. Recall #D-448-0. CODE Lot #190365 EXP 11/00. MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois. RECALLED BY MANUFACTURER, by letter dated July 26, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 37,500 vials were distributed; firm estimated that little if any remains on the market. REASON Lack of assurance of sterility (particle counts exceeding action level). ________ PRODUCT Synercid(r) I.V. (Quinupristin and Dalfopristin for injection), 500 mg, in 10 mg single dose vial, lyophilized, Rx indicated for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia. NDC #0075-9051-10. Recall #D-450-0. CODE 9G1439 9G1471 9H1854 9J2122 0A1297 9G1440 9G1438 9H1855 9L2562 0A1316 9G1470 9G1441 9H1853 0A1298 0A1419. MANUFACTURER Catalytica Pharmaceuticals, Inc., Greenville, North Carolina. RECALLED BY Aventis Pharmaceuticals, Inc., Kansas City, Missouri, by letter dated July 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Spain, Canada. QUANTITY 582,130 vials were distributed. REASON Lack of assurance of sterility (seal integrity). ________ PRODUCT SangCya(tm) Oral Solution (Cyclosporine Oral Solution, USP Modified), 100 mg/mL, Rx indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants; for severe active, rheumatoid arthritis where treatment with methotrexate is not adequate; and for the treatment of adult nonimmunocompromised patients with severe, recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy. NDC #62053- 359-05. Recall #D-451-0. CODE LOT # EXP DATE 2MG69M-------- 06/01/99 1NC30P-------- 01/01/00 1NG00M-------- 04/01/00 1NE00N-------- 03/01/00 2MH05N-------- 05/01/00 2MH06M-------- 07/01/00 2MH06MA------ 01/01/01 2MH07M-------- 08/01/00 2MH07MA------- 02/01/01 2MH04N-------- 05/01/00 2MH52M-------- 08/01/00 2MH52MA------- 02/01/01 2MH53M-------- 08/01/00 2MR63N-------- 02/01/01 2MR64N- ------ 02/01/01 2ND22M-- ----- 04/01/01 2ND22MA------- 10/01/01 2NE50M-------- 04/01/01. MANUFACTURER Eli Lilly and Company, Indianapolis, Indiana. RECALLED BY SangStat Medical Corporation, Fremont, California, by fax on July 10, 2000, by mail on July 10 and 11, 2000, by press release on July 10, 2000, followed by telephone and fax. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, United Kingdom, Germany, Hong Kong, Israel. QUANTITY 15,418 bottles were distributed. REASON Bioequivalence - Product is not bioequivalent when taken with apple juice. ________ PRODUCT Butyl-P-Aminobenzoate Injection, (Butamben (2.5% (25 mg/mL), in Methocel E-4, 1%, 10 mL amber vials, Rx compounded parenteral drug. Recall #D- 452-0. CODE 0400060, 0400052, 0500130. MANUFACTURER Medical Center Pharmacy, Fort Worth, Texas. RECALLED BY Manufacturer, by letter July 5, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas. QUANTITY 17 bottles were distributed. REASON Misbranding - Product on withdrawn list for compounding. ______ UPDATE Neomycin and Polymyxin B Sulfates Solution for Irragation, USP, USP, 1 mL, ampul (Steris Laboratories, Inc., Phoenix, Arizona), Recall #D-124-0, which appeared in the December 15, 1999 Enforcement Report, has been extended to include lot #97K040.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Etoposide Injection, USP, 20 mg/mL, (100mg/mL), 5 mL multiple dose vial, Rx used in the management of refractory testicular tumors and small cell lung cancer, and must be diluted before I.V. infusion. NDC #63323-104-05. Recall #D-449-0. CODE Lot #100006 EXP 01/02. MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois. RECALLED BY Manufacturer, by letter dated July 27, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 12,021 vials were distributed. REASON Misbranding - Some vial cartons are missing printed text.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-1135/1136-0. CODE Unit #9334252. MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee. RECALLED BY Manufacturer, by letters dated October 14, 1997, and May 22, 1998. Firm- initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who previously tested repeatedly reactive for anti HBc on two separate occasions. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1137/1138-0. CODE Unit #7430231. MANUFACTURER Carter BloodCare, Bedford, Texas. RECALLED BY Manufacturer, by letter dated January 2, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose health history screening was incomplete at the time of donation. ________ PRODUCT Red Blood Cells. Recall #B-1139-0. CODE Unit #0329001. MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 20, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product had an elevated ALT. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1142/1144-0. CODE Unit #GJ43396. MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, by fax on November 11 and 15, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Proscar. ________ PRODUCT Red Blood Cells. Recall #B-1147-0. CODE Unit #22405-7444. MANUFACTURER United Blood Services, Las Vegas, Nevada. RECALED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 6, 1999. Firm- initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-1149-0. CODE Unit #22408-3951. MANUFACTURER United Blood Services, Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 21, 1999. Firm-initiated recall complete. DISTRIBUTION Nevada. 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-1150-0. CODE Unit Numbers: 16348-3042, 16348-3045, and 16348-3046. MANUFACTURER Blood Systems, Inc., Jackson, Mississippi. RECALLED BY Manufacturer, by telephone on July 6, 1999, and by letter dated July 19, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 3 unit were distributed. REASON Blood products were manufactured from whole blood that was shipped under unacceptable temperatures.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-1134-0. CODE Unit #9335878. MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee. RECALLED BY Manufacturer, by letter dated May 16, 1997. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Whole Blood, Autologous. Recall #B-1146-0. CODE 21R55016 and 21R55017. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on June 27, 2000. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 2 units were distributed. REASON Blood products were collected in expired blood collection sets. ________ PRODUCT Fresh Frozen Plasma. Recall #B-1151-0. CODE Unit #16345-8646. MANUFACTURER Blood Systems, Inc., Jackson, Mississippi. RECALLED BY Manufacturer, by telephone on January 27, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Blood product was prepared from whole blood with an extended collection time. ________ PRODUCT Allergenic extract, Candida albicans. Recall #B-1152-0. CODE Lot #F19K4841. MANUFACTURER Hollister-Stier Laboratories, LLC, Spokane, Washington. RECALLED BY Manufacturer, by telephone on June 16, 2000, followed by letter dated June 19, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana, Arkansas, New Jersey, New York, South Carolina. QUANTITY 12 vials were distributed. REASON Allergenic extract was not labeled with an expiration date.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Troponin I Immunoassay, used in the quantitative determination of cardiac Troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the ACS:180 and ADVIA Centaur Automated Chemiluminescence System: ACS: 180 SYSTEMS AND ADVIA CENTAUR TROPONIN I Part # 110631 ACS:180 Troponin I 50T KitPart # 110632 ACS:180 Troponin I 300 KitPart # 116993 Advia Centaur Troponin I 100T KitPart # 116994 Advia Centaur Troponin I 500 T Kit. Recall #Z-886/889-0. CODE All lots. MANUFACTURER Bayer Corporation, Medfield, Massachusetts. RECALLED BY Manufacturer, by notification titled "Advia Centaur and ACS:180 Troponin I (CTN)..." Publication No. TN00397-40 on May 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Switzerland, Sweden, the Netherlands, Australia, England, France, Belgium, Korea, Hong Kong, Canada, Greece, New Zealand, Italy, Africa, Poland, Germany. QUANTITY Undetermined. REASON Revised instruction for use due to false positive results. ________ PRODUCT IGT 135mm Wireless Probe, (a pointer), an accessory to Carl Zeiss' image guided surgery system. Recall #Z-907-0. CODE Part #:146210, Serial Numbers: 403092, 397894, 397933, 398039. MANUFACTURER Image Guided Technologies, Inc., Boulder, Colorado. RECALLED BY Carl Zeiss, Inc., Thornwood, New York, by letter on May 15 and 31, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Louisiana, Iowa, Canada. QUANTITY 4 units were distributed REASON Trajectory deviation of wireless probe. The line of sight trajectory for this pointer follows the angle of the bayonet, while the tracking system trajectory follows the line from the LED’s to the tip of the bayonet in a straight line. ________ PRODUCT Ultramix Mixing Bowl Single Mix CMW, Catalog #5401-59-000, intended for use in mixing bone cement. Recall #Z-911-0. CODE Lot #UE5AC4. MANUFACTURER Depuy Orthopaedics, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter dated May 8, 2000. Firm-initiated recall complete. DISTRIBUTION England. QUANTITY 120 bowls were distributed. REASON There is a possible packaging anomaly that may allow for a non-sterile condition within the packaging or on the outside of the mixing bowl. ________ PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication. Recall #Z-913/914-0. CODE a) Software Versions 2.0 and 2.1; b) Software Version 1.0. MANUFACTURER Abbott Laboratories, Inc., Bedford, Massachusetts. RECALLED BY Medisense, Inc., Bedford, Massachusetts, by letter on March 13, 2000. Firm- initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY a) 16,179 units; b) 1,113 units were distributed. REASON Glucose values greater than 600mg/dl are downloaded incorrectly. ________ PRODUCT Hewlett Packard (HP) M1465A Airway Adapter, accessory to carbon dioxide gas analyzer, intended to provide a breath-through gas sample cell for making CO2 concentration measurements as part of the HP CO2 monitoring systems for patients weighing more than 10 kg. Recall #Z-921-0. CODE HP lots with first four digits less than 4016. MANUFACTURER Hewlett-Packard Company, Andover, Massachusetts. RECALLED BY Agilent Technologies, Inc., Andover, Massachusetts, by letter dated June 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Asia pacific, Canada, Latin America and Europe. QUANTITY 70,000 units were distributed. REASON Airway adapter out of dimensional specification which may result in air leak. ________ PRODUCT 1524, Tumisensor, all sizes, used for the diagnosis and treatment of erectile dysfunction. Recall #Z-922-0. CODE All units distributed after May 9, 2000. MANUFACTURER Life-Tech Intl., Inc., Stafford, Texas. RECALLED BY Manufacturer, by letter on June 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Utah and Minnesota. QUANTITY 24 units were distributed. REASON Product does not comply with performance standard: Electrode Lead Wires/Patient Cables, in that the connections are exposed. ________ PRODUCT Insyte AutoGuard IV Catheter, intravascular catheter to be inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids intravenously: Catalog No's. 381412, 381423, 381433, 381434, 381437, 381444, 381447, 381454, 381457, 381512, 381523, 381533, 381534, 381544 . Recall #Z-923/936-0. CODE Insyte AutoGuard IV Catheter, Cat. No. 381412: Lots 909170, 910152, 910171, 911151, 911164, 912160 381423: Lots 909166, 909169, 909171, 909172, 909180, 909181 910153, 910158, 910163, 910170, 910172, 910175, 910180, 910186, 911157, 911161, 911163, 912165, 911166, 911173, 911177, 912153, 912155, 912158, 912161, 912174, 912180, 912183, 001152, 001157, 001163, 001171. 381433: 909173, 910151, 910154, 911158, 912151, 912167. 381434: 907176, 907177, 908166, 908175, 908176, 909152, 909165, 910157, 910173, 910177, 910182, 911153, 911154, 911169, 911172, 911182, 911185, 912156, 912164, 912166, 912171, 912173, 912176, 912182, 001151, 001158, 001170. 381437: 911176 381444: 909178, 910155, 910162, 910164, 910174, 910176, 910179, 911156, 911159, 911165, 911178, 911180, 912152, 912159, 912162, 912169, 912177, 001153, 001159, 001164, 001172. 381447: 910169, 912172 381454: 910156 381457: 910167 381512: 910166, 910178, 911168, 911175, 912168. 381523: 908177, 910161, 910183, 911179, 912154, 912185, 001162. 381533: 910181, 911152, 912157. 381534: 908172, 909179, 910165, 911155, 911170, 912179, 001160. 381544: 910184, 911171, 912175. MANUFACTURER Becton Dickinson Infusion Therapy Systems, Inc., Sandy, Utah. RECALLED BY Manufacturer, by mail and visit on February 23-24, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Delaware, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, South Dakota, Tennessee, Texas, Washington state, West Virginia, Australia, Brazil, Canada, France, Italy, Japan, Mexico, Spain, United Kingdom. QUANTITY 9,511,350 units were distributed. REASON Localized skin irritation and infection at catheter insertion site. ________ PRODUCT SpO2 Extension Cables (Part Number 33 68 433 E53OU AND 33 75 834 E53OU) used with Siemens Patient Monitors: SC7000, SC8000, SC9000XL, and SC6002XL AND MIXED MONITORS-SC9000 or SC5000/6000 with SC7000, SC8000, SC900X, OR SC6002XL. Cables are connected to spO2 sensors and to either multimed or neomed pods are then connected to monitors. Recall #Z-937-0. CODE Siemens SpO2 Extension Cables (part numbers: 3368433E53OU-1 meter and 3375834e53OU- 2 meters) used with Siemens Infinity Patient Monitor Systems: SC9000XL, SC7000, SC8000, AND SC6002XL and mixed monitors SC9000 OR SC5000/6000 WITH SC7000, SC8000, SC900X, OR SC6002XL. MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by letter on May 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON Older versions of the Sp02 Extension Cables may result in high Sp02 readings. ________ PRODUCT Strykeflow Suction Irrigator II, Model/Part #250-070-500, Intended for use in laparoscopic general surgery, laparoscopic gynecological surgery and nasal surgery. Recall #Z-939-0. CODE Serial Numbers: 00065832 and 0065812. MANUFACTURER Stryker Puerto Rico, Arroyo, Puerto Rico. RECALLED BY Stryker Endoscopy, Santa Clara, California, by Letter and telephone on June 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,452 units were distributed. REASON Loss of sterility is possible. ________ PRODUCT Sandhill Scientific Schuster Anorectal Manometry Probe: a) Schuster Anorectal Probe (Adult); b), Schuster Anorectal Probe (Pediatric). Recall #Z-940/941-0. CODE a) Catalog # A86-4050; b) Catalog # A86-5050. MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, Colorado. RECALLED BY Manufacturer, by telephone beginning June 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Colorado, Georgia, Iowa, Indiana, Maryland, New Mexico, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington state, Switzerland. QUANTITY 481 units were distributed. REASON Labeling for internal and external balloons was reversed.MEDICAL DEVICE SAFETY ALERT================================
________ PRODUCT COBE BCT brand Trima Automated Blood Component Collection System, a transportable automated system that separates whole blood from a donor into its major components. Safety Alert #N-017-0. CODE Catalog #91700-000, All serial numbers. MANUFACTURER GAMBRO BCT, Inc., Lakewood, Colorado. RECALLED BY Manufacturer, by letter on August 4, 2000, and by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chili, Dominican Republic, Egypt, France, Germany, Ireland, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom and Uruguay. QUANTITY 450 units. REASON Failure to follow instructions could cause air embolism.END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2000. BLANK PAGES MAY FOLLOW. ####
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