The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
December 13, 2000 00-50________ PRODUCT Blue Seal, Salinas and Lorenzana brand of: a) Smoked Round Scad b) Smoked Sardine c) Smoked Thread Herring d) Dried Herring (or Dried Thread Herring) e) Dried Sardine (or Dried Spanish Sardine), all products are vacuum packed in plastic 6-ounce bags and the label contains a full description of the product. Recall #F-076/080-1. CODE Not Coded. All product on the market at time of recall initiation. MANFACTURER Riverside Food Manufacturing Corporation, Carson, California. RECALLED BY Manufacturer, by press release and letter on September 25, 2000. Firm- initiated recall complete. DISTRIBUTION California and New York. QUANTITY 601 cases (40 packages per case) were distributed. REASON Products, uneviscerated fish, have the potential to support the growth of and toxin production by Clostridium botulinum. ________ PRODUCT Royal Baltic brand Semi-dried North Atlantic Salmon, bulk weights, air packed or vacuum packed. Recall #F-081-1. CODE Master lot #273, and lots (package codes) 2731002, 2731003, 2731004, 2731005. MANFACTURER Royal Baltic, Ltd., Brooklyn, New York. RECALLED BY Manufacturer, by letter and press release on October 27, 2000. Firm- initiated recall complete. DISTRIBUTION New York. QUANTITY Approximately 331-pounds were distributed. REASON Product is contaminated with Listeria monocytogenes. ________ PRODUCT Harris Teeter Chocolate Ice Cream, in half-gallon containers. Recall #F-085-1. CODE Not coded. MANFACTURER Hunter Farms, a subsidiary of Harris Teeter, Inc., High Point, North Carolina. RECALLED BY Harris Teeter, Inc., Charlotte, North Carolina, by press release andtelephone on September 18, 2000, followed by E-mail. Firm-initiatedrecall complete. DISTRIBUTION Florida, Georgia, North Carolina, South Carolina, Tennessee, Virginia. QUANTITY 712 units were distributed. REASON Cartons labeled as "Chocolate Ice Cream" actually contain a second product, Snickers Ice Cream. The Snickers Ice Cream contains peanuts that are not listed on the label of the Chocolate Ice Cream. ________ PRODUCT a) Summer Krunch Slaw Salad Kit, consisting of a box/case containing bagged processed vegetables produced by the firm, and a 16-oz. unlabeled plastic tub of cole slaw dressing, packed 1 kit/case; b) Broccoli Burst Salad Kit, consisting of a box/case containing bagged processed vegetables produced by the firm, and a 16 oz. unlabeled plastic tub of cole slaw dressing packaged, 1 kit/case. Recall #F-086/087-1. CODE Use by date of 9 14 or earlier. MANFACTURER Silver Creek Fresh Prep, Garden City, Idaho. RECALLED BY Silver Creek Fresh, Inc., Garden City, Idaho, by fax on September 8, 2000, and by telephone on September 14, 2000. Firm-initiated recall complete. DISTRIBUTION Idaho and Oregon. QUANTITY a) 100 kits; b) 16 kits were distributed. REASON Products contained undeclared egg yolks. ________ PRODUCT 1) Granny's Country Cupboard Turkey N' Swiss Sub Sandwich #11004B, Net Wt. 5.5-oz.; 2) Granny's Country Cupboard Turkey & Bacon Sub Sandwich #11009B, Net Wt. 4.5-oz.; 3) Granny's Country Cupboard Ham & Cheese Croissant Sandwich #11504C, Net Wt. 5-oz.; 4) Granny's 99 cent Meal Deal Ham & Cheese Sandwich #13205A, Net Wt. 3 3/4-oz.; 5) Granny's Country Cupboard Ham & Cheese Soft Sub Sandwich #16504C, Net Wt. 6 1/2-oz.; 6)Granny's Country Cupboard Ham Turkey Club Soft Sub Sandwich #16505C, Net Wt. 6 1/2-oz.; 7) Granny's Country Cupboard Double Stuff Ham & Cheddar Sandwich #20502E, Net Wt. 7-oz.; 8) Granny's Country Cupboard Double Stuff Smoked Turkey & Swiss Sandwich #20503, Net Wt. 6-oz.; 9) Granny's Country Cupboard Double Stuff Roast Beef N' CoJac Sandwich #20505, Net Wt. 7-oz.; 10) Granny's Country Cupboard Double Stuff Ham & Cheese Sub Sandwich #23101, Net Wt. 10-oz.; 11) Granny's Country Cupboard Double Stuff Turkey & Cheese Sub Sandwich #23102E, Net Wt. 10-oz.; 12) Granny's Country Cupboard Double Stuff Turkey, Beef Club Sandwich #23103E, Net Wt. 10-oz.; 13) Granny's Country Cupboard Deli Combo on White Bread Sandwich #13601B, Net Wt. 5-oz.; 14) Granny's Country Cupboard Ham & Swiss on Rye Bread Sandwich #13602B, Net Wt. 4-oz.; 15) Granny's Country Cupboard Ham & American on White Bread Sandwich #13603B, Net Wt. 5-oz.; 16) Granny's Country Cupboard Turkey & Ham Club on White Bread Sandwich #13605B, Net Wt. 5-oz.; 17) Granny's Deli Combo 8" Submarine Sandwich #23002D, Net Wt. 11.5-oz.; 18) Granny's 8" Ham & Turkey Club Sub Sandwich #23003D, Net Wt. 9-oz.; 19) Granny's Roast Beef N' Swiss 6" Sub W' Peppers & Onions Sandwich #24004C, Net Wt. 7-oz.; 20) Granny's Italian Supreme 8" Sub W' Peppers & Onions Sandwich #23005E, Net Wt. 10-oz. Recall #F-089-108-1. CODE Products 13 through 16 are coded with sell by dates of August 25th through September 15th. The remainder of the sandwiches are coded with production dates up to and including 2350. MANFACTURER Landshire Fast Foods of Milwaukee, Inc, Muskego, Wisconsin. RECALLED BY Manufacturer, by visit on August 23, 2000, followed by letter dated August 24, 2000. Wisconsin Department of Agriculture (WDA) issued a press release on August 25, 2000. Completed recall resulted from sample analysis and follow-up by the WDA. DISTRIBUTION Wisconsin, Illinois, Indiana. QUANTITY Approximately 3,000 sandwiches were in distribution at the time of the recall initiation. REASON Products may be contaminated with Listeria monocytogenes. ________ PRODUCT HC Food brand Lotus Rootlets, in Brine, packed in 16-ounce glass jars. Recall #F-109-1. CODE Not Coded. All product on market at time of recall initiation. MANFACTURER Product of Thailand. RECALLED BY Vasinee Food Corporation, Brooklyn, New York, by an allergy alert issued on September 1 and 6, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Connecticut, Rhode Island. QUANTITY 90 cartons (24 jars per carton) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Smoked Whitefish Salad, packaged in 8-ounce containers. Recall #F-110-1. CODE Code 224 (on bottom of container) and Sell By 0918. MANFACTURER Blue Ribbon Smoked Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by letter and press release on August 29, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey. QUANTITY 76 8-ounce containers were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Blue Ribbon Smoked Fish Baked Salmon Salad, packaged in 8-ounce plastic containers. Recall #F-111-1. CODE Code 212 (on bottom of container) and Sell By 0904. MANFACTURER Blue Ribbon Smoke Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by press release and letter on August 31, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey. QUANTITY 57 8-ounce containers were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Blue Ribbon brand Cream Cheese & Lox, and Sliced Nova: a) Cream Cheese & Lox, prepared in 8-ounce size tubs b) Sliced Smoked Nova Salmon as follows: (1) Prepared in 8-ounce size, vacuum packaged in clear, flexible plastic (2) Deli-cut Nova boards, prepared in bulk sizes, vacuum packaged in clear, flexible plastic, (3) Sliced Smoked Nova Salmon, prepared in 3- ounce size, vacuum packaged in clear, flexible plastic,. Recall #F-112/113-1. CODE a) Coded 221 and sell by 1007; b) (1) 8 ounce coded 220 and sell by 0922; 222 and sell by 0924; 223 and sell by 0925; (2) Sliced Nova deli-cut board coded 223; (3) Sliced Nova 3 ounce coded 220 and sell by 0922, 221 and sell by 0923, 222 and sell by 0924, 223 and sell by 0925. MANFACTURER Blue Ribbon Smoked Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by press release and letter on August 31, 2000. Firm- initiated recall complete. DISTRIBUTION New York and New Jersey. QUANTITY a) 66 units. (b) (1)code 220 - 63 units, code 222 - 50 units, code 223 - 44 units; (2) 13 units (approx. 31.7 lbs.) distributed; (3) 196 units distributed. REASON Products may have been contaminated with Listeria monocytogenes. ________ PRODUCT Earthly Eats brand Original Vegetarian Chicken Salad in 6.5-ounce clear plastic tub containers. Recall #F-114-1. CODE Code 10-02. MANFACTURER Larus Enterprises, Inc., Ridgewood, New York. RECALLED BY Manufacturer, by telephone and visit beginning October 6, 2000, and by press release issued by the New York State Department of Agriculture and Markets (NYSDAM) on October 6, 2000. Completed recall resulted from sample analysis and follow-up by NYSDAM. DISTRIBUTION New York. QUANTITY 70 units. REASON Product contained undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I ________ PRODUCT a) Velvet Mint Chocolate Chip Ice Cream, in 1/2-gallon round carton, and 3-gallon bulk containers; b) Velvet Spumoni Ice Cream, in 1/2-gallon round carton, and 2 1/2-gallon bulk containers; c) Velvet After Dinner Mint Ice Cream, in 2 1/2-gallon bulk containers. Recall #F-082/084-1. CODE Lot Numbers: 0001 through 0314. The code represents the last digit of the year produced followed by the Julian date of manufacture. MANFACTURER Velvet Ice Cream Company, Utica, Ohio. RECALLED BY Manufacturer by letter on November 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio. QUANTITY a) 480 1/2-gallon containers, 50 3-gallon containers; b) 428 1/2-gallon containers, 50 3-gallon containers; c) 15 2 1/2-gallon bulk containers were distributed. REASON Products contain undeclared FD&C Yellow No. 5. ________ PRODUCT Japanese Salad Kit, consisting of a box/case containing bagged processed vegetables produced by the firm, and a 2 1/2 lb. unlabeled plastic bag of Japanese salad dressing, packed 1 kit/case. Recall #F-088-1. CODE Use by date of 9 14 or earlier. MANFACTURER Silver Creek Fresh Prep, Garden City, Idaho. RECALLED BY Silver Creek Fresh, Inc., Garden City, Idaho, by fax on September 8, 2000, and by telephone on September 14, 2000. Firm-initiated recall complete. DISTRIBUTION Idaho and Oregon. QUANTITY 32 kits were distributed. REASON Product contained undeclared wheat.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II ________ PRODUCT Otis Spunkmeyer: a) Banana Nut Muffins, in single packs and three packs; b) Mixed Muffins, 15 pack containing banana nut, blueberry and chocolate chip muffins. F-074/075-1. CODE Product Codes 00105 (individual muffins), 04105 (three pack muffins) and 15105 (fifteen pack product w/three muffin flavors - blueberry, banana nut and chocolate chip). Production codes 0B1172, OB2172 and OB4172. The third character represents a machine number.) Case Code OB172. MANFACTURER Otis Spunkmeyer, West Columbia, South Carolina. RECALLED BY Manufacturer, by e-mail on August 2, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, South Carolina, Tennessee, Wisconsin. QUANTITY Product 00105 - 2,160 cases (24 muffins per case); Product 04105 2,280 cases (24 muffins per case) and Product 15104 4,512 cases (20 banana nut muffins/20 blueberry muffins/20 chocolate chip muffins per case) were distributed. REASON The banana nut muffins may contain hair-like pieces of glass fibers. ________ UPDATE Caffeine Free Dr. Pepper, in 12-ounce cans, Recall #F-055-1, which appeared in the December 6, 2000 Enforcement Report is a completed recall.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III ________ PRODUCT a) Synthroid(r) tablets (Levothyroxine sodium tablets, USP) 112 mcg (0.112mg); b) Synthroid(r) tablets (Levothyroxine sodium tablets, USP), 200 mcg (0.2mg). Recall #D-053/054-1. CODE a) Lot #00045501, physician samples, 4 cards of 7 tablets; b) Lot #00045517, physician samples, 4 cards of 7 tablets. NDC Numbers: 0048-1140 and 0048-1080-96. MANFACTURER Knoll Pharmaceuticals, Jayuya, Puerto Rico. RECALLED BY Knoll Pharmaceutical Company, Mount Olive, New Jersey, by E-mail on November 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY a) 17,476 (boxes of 4 cards); b) 12,998 (boxes of 4 cards) were distributed. REASON Mis-packaging - 100 mcg product was packaged into 200 mcg card.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ________ PRODUCT Skin Guardian, in 2-ounce aerosol cans, OTC topical skin protectant. Recall #D-052-1. CODE Any code shipped after 6/28/00. MANFACTURER Unique Laboratories, Inc., Chatsworth, Georgia. RECALLED BY Manufacturer, by telephone on October 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Oklahoma. QUANTITY 110 cases (24 units per case) were distributed. REASON Product is an unapproved new drug. ________ PRODUCT Ibuprofen Tablets, USP, 400 mg, in blister packs 10 x 10 tablets, Rx oral non-steroidal anti-inflammatory agent. NDC #0364-0765-90. Recall #D- 055-1. CODE Lot #21392 EXP 12/01. MANFACTURER BASF Corporation, Shreveport, Louisiana. RECALLED BY Watson Pharmaceutical, Inc., (formerly Schein Pharmaceutical, Inc.), Florham Park, New Jersey, by letter on November 2, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,809 cartons were distributed; firm estimated that less than 5 percent of product remained on market at time of recall initiation. REASON Dissolution failure (3-month stability). ________ PRODUCT Triaminic(r) Vapor Patch(tm) Menthol Scent, Cough Suppressant, (Camphor 4.7%/Menthol 2.6%) in boxes of 6 patches, OTC for the treatment of cough. NDC #0067-0209-06. Recall #D-056-1. CODE Lot Numbers: LE505342 EXP 6/02, LE505483 EXP 6/02, LE505503 EXP 7/02, LE505536 EXP 7/02, LE505588 EXP 7/02, LE505680 EXP 8/02. MANFACTURER Lectec Corporation, Minnetonka, Minnesota. RECALLED BY Novartis Consumer Health, Inc., Summit, New Jersey, by letter on December 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 56,544 cartons of lot LE505342; 50,040 cartons of lot LE505483; 53,928 cartons of lot LE505503, 42,720 cartons of lot LE505536; 5,856 cartons of lot LE505588; 14,328 cartons of lot LE505680 were distributed. REASON Pouch seal failures (opening along top, sides and/or bottom).
RECALLS AND FIELD CORRECTIONS: DRUGS - III ________ PRODUCT Platelets, Pheresis. Recall #B-317-1. CODE Unit numbers: 16KF24889 (two units), 16KF24890 (two units), 16KF24891 (two units), 16KF24892 (two units), 16KF24893. MANFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY MANFACTURER, by letter dated July 27, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio and Arizona. QUANTITY 9 units were distributed. REASON Blood products were processed in a manner that may have compromised the sterility of the units. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma. Recall #B-330/332-1. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by fax on May 19, 2000, and by letter dated June 1, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland, Virginia, Pennsylvania, District of Columbia. QUANTITY a) 221 units; b) 22 units; c) 72 units were distributed. REASON Blood products were collected from donors whose arms had not been adequately prepared prior to venipuncture. ________ PRODUCT Corneas. Recall #B-350-1. CODE Unit numbers: 2000-11-3001 and 2000-11-3002. PROCURING FIRM Heartland Lions Eye Banks, Springfield, Missouri. RECALLED BY Heartland Lions Eye Banks, Columbia, Missouri, by telephone on November 3, 2000. Firm-initiated recall complete. DISTRIBUTION Kansas and Ohio. QUANTITY 2 units were distributed. The corneas were returned and destroyed. REASON Corneas were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc). ________ PRODUCT Corneas. Recall #B-351-1. CODE 2000-10-4007. PROCURING FIRM Heartland Lions Eye Banks, Columbia, Missouri. RECALLED BY Heartland Lions Eye Banks, Columbia Missouri, by telephone on October 25, 2000, and by letter dated October 30, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Cornea was collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis C virus and the Hepatitis B core antigen.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - II ________ PRODUCT Sterichek Total Chlorine Reagent Strips, 100-test strips, Product #811904, designed to measure low levels of total chlorine in feed water used to prepare solutions for kidney dialysis. Recall #Z-096-1. CODE Product is sold both as a part of a kit and as a single product. Kit lot numbers: 001069, 002069, and 003069. Kits expire 5/01. Bottle lots 002040, 004040, and 003040. MANFACTURER Environmental Test Systems, Elkhart, Indiana. RECALLED BY Manufacturer, by letter dated June 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Japan. QUANTITY Approximately 1,025 bottles. REASON The test strips which are intended to measure very low chlorine levels in water used for dialysis are ineffective when used to measure high levels of chlorine. ________ PRODUCT Model SmoothLASE Alexandrite Laser System, used in dermatology. Recall #Z-104-1. CODE Undetermined. MANFACTURER Leisegang Medical, Inc., Boca Raton, Florida. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on December 1, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 9 units were distributed. REASON Device failed to comply with 21 CFR 1010.2, 1040.10(g), 1040.10(h), and 1040.11(a) in that the product lacked certain required labels and operator's manual lacked calibration procedures and labels. ________ PRODUCT Omnifit Normalized Hip Stem, for use in bipolar and total hip arthroplasty in either a cemented or cementless : a) Omnifit Normalized Hip Stem (Collarless), Catalog No. 6033-0625; b) Omnifit Normalized Hip Stem (Collared), Catalog No. 6034-0625. Recall #Z-106/107-1. CODE a) Lot Code S00L303; b) Lot Code S00L269. MANFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey. RECALLED BY Manufacturer, by letter on October 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Germany, Korea, United Kingdom, Canada, Peru. QUANTITY 22 units were distributed. REASON Device was incorrectly labeled as sterile when it was not properly sterilized. ________ PRODUCT VIP Gold Ventilator; b) VIP Sterling Ventilator. Recall #Z-110/111-1. CODE a) Catalog/Part #15653; b) Catalog/Part #15654. MANFACTURER Bird Products Corporation, Palm Springs, California. RECALLED BY Manufacturer, by letter October 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 298 units were distributed. REASON There is a failure to cycle and to alarm during deliberate disconnect.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ________ PRODUCT Electronic Video Colonoscope, a gastrointestinal video system: a) Model EC-200LR, for the lower gastrointestinal tracts; b) Model No. 200LT, allows examination and treatment from rectum to cecum. Recall #Z-081/082-1. CODE Serial Numbers: a) 4Cl6lDOO3, 2Cl6lDll8, 4Cl6lDOOl, 2Cl6lDll2, 2Cl6lDO96, 2Cl6lDlO3, 2Cl6lDlO6, 2Cl6lDlll, 2Cl6lDO97, 2CI61DO98, 2Cl6lDO99, 2Cl6lDll3, 4CI61DO05 b) 4C214DO16, 3C214DO35, 4C214DO06, 4C214DO20, 4C214DO03, 3C214DO27, 4C214DO29, 4C214DO13, 4C214DO09, 4C214DO10, 4C214DO11, 4C214DO08, 4C214DO27, 4C214DO30, 4C214DO04, 4C214DO21, 4C214DO22, 4C214DO26, 4C214DO07, 4C214DO25, 4C214DO02, 4C214DO12, 4C214DO01. MANFACTURER Fuji PhotoOptical Company, Ltd., Omiya City, Saitama, Japan. RECALLED BY Fujinon, Inc., Wayne, New Jersey, by telephone on August 30, 2000, followed by letter on August 31, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 36 units. REASON The video colnonoscope bending sections cannot be properly manipulated. ________ PRODUCT Vitros C-Reactive Protein (CRP) Slides GEN 18, quantitatively measure C- reactive protein concentration in serum and plasma. Recall #Z-094-1. CODE 3718-0132-0111 EXP 9/1/99. MANFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by memorandum dated March 15, 1999. Firm-initiated recall complete. DISTRIBUTION Germany and Sweden. QUANTITY 291 packs were distributed. REASON Slides contained cartridges from two different generations that were mixed. ________ PRODUCT Immulite brand of CMV IgG Test Kit, Model L2KCV2, an in-vitro diagnostic device. Recall #Z-095-1. CODE Lot #102A. MANFACTURER Diagnostic Products Corporation, Los Angeles, California. RECALLED BY Manufacturer, by letter dated September 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Kansas, New Jersey, India, The Netherlands. QUANTITY 7 kits were distributed. REASON The barcode used to label the adjustor kit component had an error that caused the system to reject it. The printing error prevents the barcode from being read and the instruments will not process the assay and patient results will not be obtained. ________ PRODUCT ACN Biopsy Needle, Part #(model) ACN1410MF, used for obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast and various other soft tissue lesions. Recall #Z-105-1. CODE PART NUMBER ACN1410MF and the following lot numbers: 01101469, 01101470, 01101471, 01221644, 01231645, 01241646, 01241647, 01241648, 01261800, 01291801, 01381715, 01381737, 01391736, 01441738, 01581917, 01581961, 01602025, 01612157, 01682158, 01882602, 01922675, 01952765, 02002809, 02022810, 02032811, 02062812, 02203477, 02283673, 02303674, 02343877, 02373933, 02373934, 02494027, 02564117, 02624228, 02634227 and 02664354. MANFACTURER Medical Device Technologies, Inc., Gainesville, Florida. RECALLED BY Manufacturer, by letter on October 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 2,374 units were distributed. REASON Needle did not operate smoothly in gun, potentially affecting QUANTITY of sample. ________ PRODUCT a) Osteonics C-Taper Head 26 mm, + 0, Catalog No. 06-2600; b) Osteonics C-Taper Head 26 mm, +10, Catalog No. 06-2610, indicated for use of the Osteonics Ion Implanted Femoral Bearing Series as part of a universal hip replacement. Recall #Z-108/109-1. CODE a) Lot No. 56629202 b) Lot No. 56584201. MANFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey. RECALLED BY Manufacturer, by letter on September 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Australia. QUANTITY 32 units were distributed. REASON Packages labeled Catalog No. 06-2600 (Osteonics C-Taper Head 26 mm, + 0) contained Catalog No. 06-2610 (Osteonics C-Taper Head 26 mm, +10), and vice versa. ________ PRODUCT Immulite 2000 PAP IVD Test Kit, for the chemiluminescent enzyme immunometric assay for the quantitative measurement of prostatic acid phosphatase. Recall #Z-112-1. CODE Lot # L2KPA2 6103 EXP 11/30/00. MANFACTURER Diagnostic Products Corporation, Los Angeles, California. RECALLED BY Manufacturer, by technical bulletins faxed on November 3 and 6, 2000, followed by telephone on November 6, 2000 Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Missouri, New Jersey, Texas, Utah, Australia, Brazil, Germany, Italy, Spain, Sweden, Switzerland, Turkey, United Kingdom. QUANTITY 17 kits were distributed. REASON The second full reagent wedge of the same lot on the system will erroneously be recognized as being empty, no further processing will take place and test results will not be possible to obtain. ________ PRODUCT ROCHE c.f.a.s. Calibrator for automated systems, Catalog No. 759350, used for calibration of Roche methods on clinical chemistry analyzers. Recall #Z-113-1. CODE Lot Nos. 199608 through 199611, 199845 through 199848. MANFACTURER Roche Diagnostics, GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corp., Indianapolis, Indiana, by letter dated October 31, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY Approximately 10,000 kits were distributed. REASON The setpoints of the master lot and customer lot produce small bias that may produce calcium results too high. ________ PRODUCT Abbott Multiconstituent Calibrator, for use with the ALCYON Analyzer and AEROSET System for the calibration of albumin, calcium, cholesterol, creatinine, glucose, phosphorus, total protein, triglycerides, urea nitrogen, and uric acid. Recall #Z-114-1. CODE List #1E65-01 and Lot #54650M100. MANFACTURER Medical Analysis Systems, Inc., Camarillo, California. RECALLED BY Abbott Laboratories, Inc., Irving, Texas, by letter June 14, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide, Mexico, Venezuela, Colombia, Dominican Republic, Canada, Germany, Hong Kong, Singapore, Australia, New Zealand, Curaco.. QUANTITY 1,733 kits were distributed. REASON The stability failure of the multiconstituent calibrator (MCC). Creatinine concentration has decreased from the test June 1, 2000 due to high iron content. The decrease in creatinine concentration in the MCC may result in an upward shift of creatinine results of up to 12%. The expiration date of this lot is November 3, 2000.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ________ PRODUCT a) Blood Stop Powder, in 6-ounce and 16-ounce bottles. OTC for use on horses, cattle, sheep, cats and dogs, under the following labels: Dionne Products, and IBS Inc.; b) Dionne White Dehorning Paste and Dionne Black Dehorning Paste, in 6- 0unce bottles, manufactured for Dionne Products and Dehorning Paste, in 6-ounce bottles, manufactured for Martex Group, OTC for the destruction of horn-forming tissue in baby calves. Recall #V-007/008-1. CODE All Lots. MANFACTURER Wendt Professional Laboratories, Inc., Belle Plaine, Minnesota RECALLED BY Qualis, Inc., Des Moines, Iowa, by letter dated September 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY The following amounts of products have been distributed: Blood Stop Powder, 16-ounce - 9,744 bottles Blood Stop Powder, 6-ounce. - 4,836 bottles White Dehorning Paste - 7,704 bottles Black Dehorning Paste - 2,088 bottles. REASON Products are unapproved new animal drugs due to label claims.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS III
END OF ENFORCEMENT REPORT FOR DECEMBER 13, 2000.
Office of Public Affairs
Hypertext uploaded by tg 2000-DEC-12.