Correction to recall number F-202-3: FDA has recently been advised by Scrava Pty. Ltd, Smithfield, N.S.W. Australia that the recalled Pinuli Herbal Tea was packed for, rather than manufactured by, Scrava Pty. Ltd. by Instituto Botanica La Selva, Monte Video, Uruquay.
ENFORCE 01/27/1993Recalls and Field Corrections: Foods -- Class I -- 01/27/1993 JANUARY 27, 1993 93-4 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I PRODUCT Cold Smoked Sablefish (black cod), sold as loose fillets packed in boxes. Recall #F-125-3. CODE NONE. All product smoked on 10/8/92. MANUFACTURER Blue Ribbon Smoked Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by letter November 17, 1992. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY Approximately 189 pounds were distributed. REASON The product is contaminated with Listeria monocytogenes. PRODUCT (a) Triple Decker (Ham and Turkey) QT Quik'n Tasty Jumbo Sandwich, 10.5 ounces; (b) Quik'n Tasty QT Roast Beef'n Turkey Combo Sandwich, 5.5 ounces; (c) Quik'n Tasty QT Texas Ham'n Cheese Sandwich, 6 ounces. Recall #F-126/128-3. CODE (a) 212 (Julian date of manufacture); (b & c) All lots. MANUFACTURER Quik'n Tasty Foods, Belton, Missouri. RECALLED BY Manufacturer, (a) by telephone November 3, 1992; (b) by telephone December 4, 1992. Firm-initiated recall ongoing. DISTRIBUTION Missouri, Kansas, Iowa, Oklahoma, Illinois, Georgia. QUANTITY (a) 8,290 sandwiches; (b) 39,294 sandwiches; (c) 82,656 sandwiches were distributed. REASON The products contain Listeria monocytogenes. PRODUCT (a) La Loma brand Meatless Fried Chicken, manufactured from texturized vegetable protein, packaged in 8 ounce boxes; (b) Grillers, artificial hamburger flavored patties, manufactured from vegetable protein, 4 patties per box, 12 boxes per case. Recall #F-129/130-3. CODE Lot numbers: (a) 2259-30; (b) 2272-10. MANUFACTURER Worthington Foods, Inc., Worthington, Ohio. RECALLED BY Manufacturer, (a) by letter December 1, 1992; (b) by letter November 13, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY (a) 229 cases; (b) 1,474 cases were distributed. REASON The products contain Listeria monocytogenes. PRODUCT (a) Dole brand Coleslaw Mix, in 10 ounce, 1 pound, 3 pound and 5 pound plastic bags; (b) Dole brand Shredded Green Cabbage, in 1 pound plastic bags; (c) Dole brand Pre-Cut Green Cabbage, in 5 pound plastic bags; (d) Aunt Mid's Coleslaw Mix, in 1 pound plastic bags. Recall #F-162/165-3. CODE All lots and all shipping dates. MANUFACTURER Dole Fresh Vegetables Company, Marina, California. RECALLED BY Dole Fresh Vegetables Company, Inc., Salinas, California, by press release and letter November 14, 1992, and letters of November 18, 19, 1992. Firm-initiated recall ongoing. DISTRIBUTION (a-c) Nationwide, Canada; (d) Michigan, Ohio, Canada. QUANTITY Approximately 1,700 tons were distributed. REASON Products contain Listeria monocytogenes. PRODUCT Pride of Alaska Snow Crab Legs and Claws, 2.5 pound pack. Recall #F-201-3. CODE 72992A, 72992B, 72992C, 72992D located on the inside flap of the box and the shipping case. MANUFACTURER Unisea Foods, Inc., Redmond, Washington. RECALLED BY Manufacturer, by telephone. Firm-initiated recall complete. DISTRIBUTION Northwest United States and Canada. QUANTITY 109 cases (10 packs per case) were distributed. REASON Product is contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II PRODUCT Various ice cream and sherbet products, in pint, quart, half gallon and three gallon containers: (a) Buttered Pecan Ice Cream; (b) Butter Brickle Ice Cream; (c) Caramel Toffee Crunch Ice Cream; (d) Cookies and Cream Ice Cream; (e) Macinac Island Fudge Ice Cream; -2- (f) French Vanilla Ice Cream; (g) Lemon Ice Cream; (h) Mint Chip Ice Cream; (i) Lime Sherbet. Recall #F-177/185-3. CODE All lots without extra ingredient sticker label. MANUFACTURER Freer's Ice Cream Company, Inc., Elkhart, Indiana. RECALLED BY Manufacturer, by visit beginning December 14, 1992. Firm-initiated field correction ongoing. DISTRIBUTION Indiana, Michigan. QUANTITY Unknown. REASON Product contains undeclared FD&C Yellow No. 5. PRODUCT Pinuli Herbal Tea, 25 teabags per box. Recall #F-202-3. CODE All lots. MANUFACTURER Scrava Pty. Ltd., Smithfield N.S.W., Australia. RECALLED BY Victory Markets, Inc., Norwich, New York, by letter November 27, 1992. Firm-initiated recall ongoing. DISTRIBUTION New York, Pennsylvania. QUANTITY Firm estimates not more than 800 boxes remain on the market. REASON Product contains a food additive, Cassia Senna, in excess of GRAS limits. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II PRODUCT Propylthiouracil Tablets, 50 mg, a Rx drug used for treatment of hyperthyroidism, in bottles of 100 and 1,000. Recall #D-103-3. CODE Lot numbers: 0I089AK EXP 10/93, 1C089EV EXP 5/94. MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey. RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter dated January 6, 1993. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 19,530 bottles of lot 0I089AK and 16,347 bottles of lot 1C089EV were distributed. REASON Product does not meet dissolution specifications. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III PRODUCT Seba-Clear Therapeutic Shampoo, in 1 fluid ounce (professional sample) and 4 fluid ounce bottles, non-Rx product labeled as an antiseborrheic. Recall #D-102-3. CODE Lot #32792, manufactured March 27,1992. MANUFACTURER Heran Pharmaceutical, Inc., San Antonio, Texas. RECALLED BY Manufacturer, by letter January 8,1993. Firm-initiated recall ongoing. DISTRIBUTION Unknown. QUANTITY 1,116 4-fluid ounce bottles and an unknown number of sample size bottles were distributed. REASON Product is subpotent for salicylic acid ingredient and also not in compliance in formulation for dandruff and psoriasis products. -3- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III PRODUCT Source Plasma. Recall #B-128-3. CODE Unit numbers: 22916921, 22916938, 22916945, 22916952, 22916969, 22916976, 22916983, 22916990, 22917003, 22917010, 22917027, 22917034, 22917041, 22917058, 22917065, 22917072, 22917089, 22917096, 22917126, 22917133, 22917140, 22917157, 22917164, 22917195, 22917201, 22917218, 22917225, 22917232, 22917249, 22917256, 22917287, 22917294, 22917300, 22917317, 22917324, 22917331, 22917348, 22917355, 22917362, 22917379, 22917386, 22917409, 22917416, 22917423, 22917430, 22917454, 22917461, 22917478, 22917485, 22917492, 22917508, 22917515, 22917539, 22917546, 22917553, 22917560, 22917577, 22917591, 22917614, 22917621, 22917638, 22917669, 22917676, 22917683, 22917690, 22917706, 22917713, 22917737, 22917744, 22917775, 22917782, 22917805, 22917812, 22917829, 22917836, 22917843, 22917850, 22917867, 22917874, 22917881, 22917898. MANUFACTURER Premier BioResources, Inc., Corpus Christi, Texas. RECALLED BY Premier BioResources, Inc., Fort Worth, Texas, by telephone October 7, 1992. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 81 units. REASON Source Plasma, exposed to unacceptable temperatures, was distributed. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II PRODUCT Drills used for Integral Biointegrated Dental Implant Systems: (a) 10 mm Intermediate Drill, Catalog #0203; (b) 8 mm Final Spade Drill, Catalog #0207; (c) Surgical Instrumentation Kit, Catalog #0350; (d) Surgical Autoclave Kit, Catalog #0326. Recall #Z-001/004-3. CODE Lot numbers: (a) 926038; (b) 926039; (c) 926200 0005; (d) 926006 0005. MANUFACTURER Calcitek, Inc., Carlsbad, California. RECALLED BY Manufacturer, by telephone November 17, 1992. Firm-initiated recall complete. DISTRIBUTION Nationwide, UK. QUANTITY (a) 50 units; (b) 14 units; (c) 1 kit; (8) 1 kits. All product involved was returned and reworked. REASON Drills packaged and labeled as 8 mm Final Spade Drills were actually 10 mm Intermediate Drills and vice versa. PRODUCT Luxar Model LX-15 and LX-20 C02 Surgical Lasers. Recall #Z-164-3. CODE Serial numbers: Undetermined. MANUFACTURER Luxar Corporation, Bothell, Washington. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan December 8, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. -4- QUANTITY 639 units were distributed. REASON Noncompliance with performance standards for laser products in that the mechanical mounting of the laser beam shutter could become loose possibly resulting in failure to block emission from the device. PRODUCT AC Adapter/Charger, date codes 1191 or 0192, used with Laerdal Compact Suction Units with serial numbers ending in A282 through E042, used as an accessory with a compact suction unit. Recall #Z-167-3. CODE Date codes 1191 or 0192 on adapter/charger. MANUFACTURER DeVilbiss Health Care, Inc., Somerset, Pennsylvania. RECALLED BY Manufacturer to sole direct account, Laerdal Medical Corporation on August 14, 1992. Laerdal sent 2 "Important Notifications" dated August 12, 1992 and August 17, 1992 to distributors. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 497 units. REASON The adapter/charger may fail to adequately charge the internal battery, resulting in the battery failing to operate the device as long as stated in the labeling. PRODUCT Adapter/Charger with date codes 0491 to 0692 used with the DeVilbiss Pulmo-Aide Traveler, Model 6610D, which is a portable compressor/nebulizer. Recall #Z-168-3. CODE Date codes 0491 to 0692. MANUFACTURER Devilbiss Health Care, Inc., Somerset, Pennsylvania. RECALLED BY Manufacturer to distributors via a service bulletin in October 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON The adapter/charger may fail to adequately charge the internal battery, resulting in the battery failing to operate the device as long as stated in the labeling. PRODUCT VHA+Plus brand Non-sterile Latex Examination Gloves: (a) Small/Medium, Product #V7266; (b) Medium, Product #V7857. Recall #Z-204/205-3. CODE Lot numbers: (a) 205016105, 206000105, 206015805, 206020505; (b) 206421505, 208403105. MANUFACTURER Ansell, Inc., Byagama, Sri Lanka. RECALLED BY Ansell, Inc., Dothan, Alabama, by telephone on or about December 12, 1992, followed by letter December 23, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 140 cases (20 boxes of 100 gloves per box) were distributed. REASON Gloves failed to comply with requirements for patient examination gloves due to leakage defects. -5- PRODUCT Baxter Custom Sterile Surgical Packs which contain Argyle 18 French Ferguson Left Vent Catheters: (a) CV Accessory Pack, Catalog Numbers SCV41BSAMW, SCV41BSAMX, SCV41BSAMY, SCV41BSAMZ (b) CV Pack, Catalog Nos. SCV46OHHCC, SCV46OHHCB, SCV46OHHCA, SCV46OHSHH, SCV46OHSHI, SCV46OHSHG, SCV46OHSHF, SCV46OHSHC, SCV46OHSHE, SCV46OHSHD, SCV46OHMCA (c) Cheatam/Kanaly CV Pack, Catalog Nos. SCV47BSMHF, SCV47BSMHE, SCV47BSMHD, SCV47BSMHC (d) Toal/Kanaly/Randolph CV Pack, Catalog No. SCV47MJNRA (e) CV Set Up Pack, Catalog Nos. SCV47BSPHL, SCV47BSPHM, SCV47BSPHK, SCV47BSPHI, SCV47BSPHJ, SCV47BSPHH, SCV47BSPHG, SCV47BSPHE (f) Open Heart Pack, Catalog Nos. SCV43OH691, SCV43OH692, SCV43OH69C, SCV43OH69A, SCV43OH69B (g) Knee Pack, Catalog No. SOP39KNMCF (h) Coronary Tray, Catalog Nos. SAN21CCMLC, SAN23CCMLD, SAN23CCMLE, SAN21CCMLB, SAN21CCMLA (i) Valve Tray, Catalog Nos. SCV21HVMLB, SCV23HVMLC, SCV21HVMLA (j) Open Heart Set Up Pack, Catalog Nos. SCV47BSCCC, SCV47BSCCD, SCV47BSCCB, SCV47BSCCA (k) CV Pack II, Catalog Nos. SCV46BSMMC, SCV46BSMMB, SCV46BSMMA. Recall #Z-220/230-3. CODE Catalog Nos Manufacturing Dates (a) #SCV41BSAMW 7/7/92, 9/30/92, 1/17/92, 10/21/91, 11/27/91 SCV41BSAMX 3/8/91, 5/6/91, 12/11/90 SCV41BSAMY 7/2/90, 9/19/90, SCV41BSAMZ 1/9/90, 10/13/89, 5/4/89 (b) SCV46OHHCC 7/27/92, 9/24/92, 4/17/92 SCV46OHHCB 2/18/92, 2/13/91, 11/6/91 SCV46OHHCA 1/7/91, 6/5/90, 9/20/90, 10/26/89, 5/25/89 SCV46OHSHH 6/10/92 SCV46OHSHI 8/26/92 SCV46OHSHG 4/6/92, 2/28/92 SCV46OHSHF 2/12/92, 2/21/91, 6/17/91, 8/20/91, 10/21/91 SCV46OHSHC 6/14/90, 3/28/90, 9/28/89, 5/25/89, 4/25/89 SCV46OHSHE 12/19/90 SCV46OHSHD 10/8/90 SCV46OHMCA 4/24/89, 9/26/89 (c) SCV47BSMHF 7/10/92, 4/2/92 SCV47BSMHE 11/6/91, 11/13/90 SCV47BSMHD 3/8/90, 4/19/90 SCV47BSMHC 2/21/90 (d) SCV47MJNRA 8/14/92, 6/3/92 (e) SCV47BSPHL 8/4/92, 5/6/92 SCV47BSPHM 9/22/92 SCV47BSPHK 2/10/92, 12/26/91 SCV47BSPHI 1/15/91, 8/16/91 SCV47BSPHJ 4/24/91 -6- SCV47BSPHF 3/23/90, 1/10/90 SCV47BSPHH 11/1/90 SCV47BSPHG 5/15/90 SCV47BSPHE 2/23/89 (f) SCV43OH691 7/14/92 SCV43OH692 9/11/92 SCV43OH69C 6/4/92, 4/27/92 SCV43OH69A 1/18/91, 2/9/91 SCV43OH69B 8/23/91, 9/23/91, 11/22/91, 12/31/91 (g) SOP39KNMCF 2/13/92 (h) SAN21CCMLC 2/8/91, 3/20/91 SAN23CCMLD 5/20/91 SAN23CCMLE 7/19/91 SAN21CCMLB 12/4/90 SAN21CCMLA 10/16/90 (i) SCV21HVMLB 1/18/91 SCV23HVMLC 8/9/91 SCV21HVMLA 11/26/90, 10/12/90 (j) SCV47BSCCC 3/1/91 SCV47BSCCD 5/1/91, 6/21/91, 7/18/91, 9/5/91, 12/18/91 SCV47BSCCB 11/14/90 SCV47BSCCA 8/14/90, 3/29/90 (k) SCV46BSMMC 2/28/91, 4/1/91 SCV46BSMMB 1/8/91 SCV46BSMMA 5/29/90, 10/27/90, 9/17/90, 3/1/89 MANUFACTURER Sherwood Medical, St. Louis, Missouri (catheter). RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by letter October 20, 1992. Firm-initiated recall ongoing. DISTRIBUTION Texas, Oklahoma, Iowa, North Carolina, Florida. QUANTITY 7,260 custom packs were distributed; firm estimates 100 packs remain on the market. REASON The Argyle 18 French Ferguson Left Vent Catheters (Sherwood Catalog No. 5558-590013 recalled under Z-051-3) contained in these packs may contain a hole or channel which could allow blood or air leakage at the proximal end. PRODUCT Gas Analyzer used with certain lots of the Bird Sentry Blender Part #10209. The blender provides precise mixing of medical grade air and oxygen which is delivered via breathing circuits to the patient. Recall #Z-219-3. CODE Serial numbers: KCF01855 through KCF01858, KCF02110 through KCF02159, KCF02772 through KCF02786. MANUFACTURER Vascular Technology, Inc., Chelmaford, Massachusetts (component). RECALLED BY Bird Products Corporation, Palm Springs, California, by letter dated September 10, 1992, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Illinois, Louisiana, New York, Minnesota, Tennessee, Utah, England, Sweden. QUANTITY 59 units were distributed. REASON A stray segment, period, or colon may appear on the analyzer display panel. -7- PRODUCT Quartz Micropipette Puller Model P-2000, used to pull glass or quartz tubing under controlled heating conditions to make micropipettes with the desired characteristics. Recall #Z-246-3. CODE Serial numbers: Undetermined. MANUFACTURER Sutter Instrument Company, Novato, California. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan dated December 23, 1992. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY Between 11 and 20 units were distributed. REASON Noncompliance with performance standard for light-emitting products. The noncompliance consists of inadequate protective housing, a lack of redundant microswitch interlocks, incomplete operation's manuals, missing certification statement and date of manufacture, no initial report, and no formalized, documented quality control test procedures. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III PRODUCT Endotyer, suturing aid. Recall #Z-203-3. CODE Catalog #GS-4130. MANUFACTURER Birtcher/Solos Medical Systems, Duluth, Georgia. RECALLED BY Birtcher Medical Systems, Irvine, California, by telephone, followed by letter November 23, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 69 units were distributed. REASON The device was marketed without an approved 510(k). PRODUCT Cards O.S. Strep A Test Kit, an in-vitro diagnostic device and its purpose is to detect group A streptococcal antigen directly from throat swabs. Recall #Z-217-3. CODE Catalog numbers Lot numbers CR7740 490314.1, 490470.1, 490497.1, 500227.1, 500227.2, 530135.1 CR7741 490316.1, 490316.2, 490472.1, 530043.1, 530044.1, 530044.2, 530155.1 CR7742 490318.1, 490318.2 MANUFACTURER Pacific Biotech, Inc., San Diego, California. RECALLED BY Manufacturer, by letter dated December 1, 1992. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Austria, Canada, Denmark, Finland, Italy, Spain, Sweden, Switzerland. QUANTITY 2,717 kits were distributed. REASON The product may exhibiting false positive results. -8- RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS III PRODUCT Coop Pig Starter #10 CSP and #20 CSP, in 50 pound multi-layered paper bags. Recall #V-011-3. CODE HJ262 and HJ1452 (#10); HJ222, HJ1202, HJ1972, IJ1222 (#20). MANUFACTURER Farmland Industries, Inc., Kansas City, Missouri. RECALLED BY Farmland Industries, Centralia, Missouri, by telephone, followed by letter dated October 10, 1992 and December 2, 1992. Firm-initiated recall complete. DISTRIBUTION Missouri, Illinois. QUANTITY 4,216 50-pound bags were distributed. REASON Products are subpotent in chlortetracycline and sulfathiazole. INJUNCTIONS: PRODUCT Liquid Injectable Silicone (polydimethylsiloxane) (LIS)(91- 663-382). DEFENDANTS James E. Fulton, Jr. M.D., Ph.D., individual, and Vivant, Inc., also known as Fulton Pharma-Cal, Inc., a corporation, and Acne Research Institute, Inc., a non-profit research foundation, Newport Beach, California. FILED February 28, 1992 - Complaint; December 2, 1992 - Consent decree of Permanent Injunction; U.S. District Court for the Central District of California; Civil #92-1279 WJR (EEx), INJ 1263. DISPOSITION Liquid injectable silicone intended for injection into humans does not have in effect the required approved premarket application or investigational device exemption and thus the defendants are prohibited from the following activities: interstate commerce of LIS (introduction, delivery for introduction, or receipt in interstate commerce); manufacturing, processing, holding for sale, or storing LIS; promoting through the use of advertising or labeling the use of LIS in medical or surgical procedures; and using or administering LIS in medical or surgical procedures on humans. These activities are prohibited unless and until there is in effect an approved application for premarket approval or an approved application for investigational device exemption that authorizes the defendants' use of LIS. These restrictions apply without regard to whether the defendants contend that the activity is undertaken in connection with the practice of medicine. SEIZURES: PRODUCT Single use syringes (92-657-114/21). CHARGE Adulterated and Misbranded - The devices' quality falls below that which they purport or are represented to possess, in that they are labeled to: (1) be sterile, whereas some are packaged in defective packaging which cannot assure or maintain sterility; and (2) all bear precise markings and gradations, -9- whereas the markings and gradations are illegible, omitted, or partially omitted; and, the devices' labeling is false and misleading as indicated above. FIRM Mediverse, Inc., St. Paul, Minnesota. FILED December 9, 1992; U.S. District Court for the District of Minnesota; Civil #3-92-820, FDC #66622. SEIZED December 21, 1992 - goods valued at approximately $21,000. PRODUCT Radiation detectors (92-590-536/7). CHARGE Misbranded - The devices' labeling fails to bear adequate directions for use for the purposes for which they are intended. FIRM Keizer Chiropractic Clinic, Salem, Oregon. FILED December 2, 1992; U.S. District Court for the District of Oregon; Civil #92-6404-HO, FDC #66358. SEIZED December 2, 1992 - goods valued at approximately $1,600. PRODUCT Benztropine Mesylate Tablets, USP (92-613-907/910). CHARGE Adulteration - the methods used in, and the facilities and controls used for, the product's manufacture, processing, packing, and holding do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations. FIRM Sidmak Laboratories, Inc., East Hanover, New Jersey. FILED July 22, 1992 - U.S. District Court for the District of New Jersey; Civ. #92-3031; FDC #66463. SEIZED August 5, 1992; goods valued at approximately $470,000. PRODUCT Peas and beans (92-676-333). CHARGE Adulterated - Some of the articles consist in part of a filthy substance. All of the articles have been held under insanitary conditions whereby they may have become contaminated with filth. FIRM Casera Foods, Inc., Barceloneta, Puerto Rico. FILED October 20, 1992; U.S. District Court for the District of Puerto Rico; Civ. #92-2471(CC); FDC #66610. SEIZED December 4, 1992 - goods valued at approximately $41,000. -10- END OF ENFORCEMENT REPORT FOR JANUARY 27, 1993. BLANK PAGES MAY FOLLOW.