August 22, 2001 01-33
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-512-1, Summer Harvest Brand Express Mix, packaged in 1 ounce foil bag, labeled in part, '*** Delta Express *** Summer Harvest Brand xpress Mix *** Net Wt. 1 oz. *** Kings *** Delicious *** KING NUT COMPANY SOLON, OH 44139 *** Packed especially for Delta Express ***' CODE: Ink stamped on the back of the bags is: T0106102. (CATALOGUE NO. 25601). REASON: The product contained undeclared peanuts. MANUFACTURER/RECALLING FIRM: King Nut Company, Solon, OH RECALLED BY: Manufacturer, by telephone on 3/20/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: FL QUANTITY: 27 cases (8,100 bags) _______________________________ RECALL NUMBER, PRODUCT AND CODE: The following ready-to-eat refrigerated beef sandwiches were recalled: 1) F-509-1 Pic-a-Deli Cheeseburger, 3.25 oz. 2) F-510-1 Pic-a-Deli BBQ Beef Rib, 6.50 oz. 3) F-511-1 Pic-a-Deli Double Cheeseburger, 5.25 oz. CODE: All Exp/Pull Dates: 'FEB 28 01' through 'MAR 14 01'. REASON: The products contained undeclared dried whole eggs. MANUFACTURER/RECALLING FIRM: SanCo Foods, Inc., North Canton, OH RECALLED BY: Manufacturer, by telephone beginning on 3/2/2001, followed by visit. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH, PA, and VA. QUANTITY: 2000 sandwichesRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: Waffles in three varieties - F-450-1, Homestyle Waffles (may be labeled as "Homestyle", "Old Fashioned Round" or as "Waffles" - no variety) F-451-1, Buttermilk Waffles F-452-1, Blueberry Waffles The waffles are under 8 brand names: Stater, Roundy's, Sugerencia, Food Club, Spartan, DeMoulas, Super G, and Stop and Shop. The waffles come in either an 8 count, 10 count, 12 count, or 16 count package. CODE: All lots distributed prior to June 1, 2001. REASON: The products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. MANUFACTURER: Lakeshore Frozen Foods Inc., Lake City, PA RECALLED BY: Manufacturer, by faxed a recall letter on 6/1/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, IL, IN, MA, MD, MI, OH, TX, VT, and WI QUANTITY: 136377 cases/6 units per case ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-459-1, Shernoff's Egg Potato Salad, 10 lb plastic container, CODE: use by dates 4/27/01, 5/3/01, 5/10/01, and 5/17/01. REASON: The product contained undeclared FD&C Yellow No. 5 and FD&C Blue No. 1. MANUFACTURER/RECALLING FIRM: Shernoff's Salads, Philadelphia, PA RECALLED BY: Manufacturer, by telephone on 4/20/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA and NJ QUANTITY: 6000 lbs _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-495-1, FUN-E-CHIPS, in 10 LB bulk cases. The label states in part, ' ***DISTRIBUTED BY TARRIER FOODS CORP. COLUMBUS, OH 43228 *** COR 167 DAIRY #0571 PRODUCT OF CANADA*** ' CODE: The date code on the case labels is #0571. The Item number is 0669. 'COR 167 DAIRY' is also stamped on the labels. REASON: The product may contain undeclared milk protein. MANUFACTURER: Neilson International Limited, Toronto, CANADA RECALLED BY: Tarrier Foods Corporation, Columbus, OH, by telephone on 6/12/2001, followed by a mailed recall notice on 6/15/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD, IN, MN, PA, OR, MS, AZ, CO, MT, CA, MA, and KY QUANTITY: 5,589 cases (10 LBS each) _______________________________ RECALL NUMBER, PRODUCT AND CODE: a) F-499-1 Mills Fleet Farm Butterscotch Bits, Packed for Mills Fleet Farm, Appleton, WI., in two sizes Net Wt. 1 Lb. 12 Oz. and Net Wt. 12 Oz b)F-500-1 Eillien's Butterscotch Chips, in two sizes Net Wt. 12 Oz. and Net Wt. 24 Oz. CODE:All lots on the market at the time the recall was initiated. REASON: a) The product contains undeclared milk ingredients. b) The product contains undeclared FD&C Yellow No. 6 Lake. MANUFACTURER: Clasen Quality Coatings, Inc., Middleton, WI RECALLED BY: Eillien's Candies, Inc., Green Bay, WI, by letter 2/26/00. FIRM INITIATED RECALL: Completed DISTRIBUTION: MN, ND, WI QUANTITY: Est. amt. in dist.: 2855 12 oz. packages and 800 28 oz. packages (total includes product recalled under F-501-1 Class III). ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-502-1, Hawaiian Delight, Fruit Salad, packed in 4.5 LB and 9 LB plastic tub containers. CODE: No code REASON: The product contains undeclared skim milk and FD&C Red No. 40. MANUFACTURER/RECALLING FIRM: Frank L. Harter & Sons, Inc., Cincinnati, OH RECALLED BY: Manufacturer by telephone on 7/16, 17/2001, and hand delivered a letter on 7/18/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Cincinnati, Ohio and Northern Kentucky QUANTITY: 225 lbs ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-466-1, Caffeine Free Diet Coke in 2 liter PET bottles, Code:SEP0301UVA REASON: The bottles labeled as Caffeine Free Diet Coke actually contain regularly sweetened Caffeine Free Coca Cola Classic. MANUFACTURER: Coca Cola Enterprises, Inc., San Leandro, CA RECALLED BY: National Quality Assurance Coca Cola Enterprises, Inc., Atlanta, GA, called, faxed, visited and e-mailed recall notifications to all implicated consignees on 6/13/01 to discontinue sale, sub-recall product to the retail level and also requesting return of the product. Letters were sent on 6/19/01. The firm will follow-up by telephone and visits. FIRM INITIATED RECALL: Completed DISTRIBUTION: Northern CA QUANTITY: 157 cases ______________________________ RECALL NUMBER,PRODUCT AND CODE: F-465-1, Friendly's "Mint Chocolate Chip"Ice Cream, Half-Gallon Container Code Date: Marked with an expiration date of April 27, 2002, embossed in the form of "27Apr02" or "Apr2702" REASON: The cartons actually contain Purely Pistachio Ice Cream. The Purely Pistachio Ice Cream contains pistachios which are not listed as an ingredient on the Mint Chocolate Chip Ice Cream label. MANUFACTURER/RECALLING FIRM: Friendly Ice Cream Corporation, Wilbraham, MA RECALLED BY: Friendly Ice Cream Corp. issued a Press Release on 6/20/01 and by telephone and fax on 6/21/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MA, ME, RI, CT, VT, NH, NY, NJ, PA, OH, VA, MD, DC, FL, TN, IN, WV, MI, NC and SC. QUANTITY: 2630 Sleeves (6 units/sleeve)RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
______________________________ RECALL NUMBER, PRODUCT AND CODE: F-460-1, Shredded Swiss Cheese The Swiss cheese is shipped as 6 units per cardboard box. F-461-1, Shredded Cheddar Cheese The cheddar cheese is shipped as 4 units per cardboard box. Each type of cheese is sold as a 5 lb unit in a plastic bag. CODE: Expiration date AUG 14 REASON: The products were contaminated with mold. MANUFACTURER/RECALLING FIRM: Laubscher Cheese Company, Inc., Mercer, PA RECALLED BY: On 6/7/01, the recalling firm verbally notified their broker and the accounts. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NH, MA and OH QUANTITY: 10610 pounds ______________________________ RECALL NUMBER, PRODUCT AND CODE: The following ice cream brand names and varieties are subject to recall: F-453-1, Buehlers Cookies 'N Cream; F-454-1, Fishers Cookies ' N Cream; F-454-1, Valley Rich Cookies 'N Cream; F-456-1, Valley Rich Blueberry Cobbler; F-457-1, Valley Rich Chocolate Caramel Cashew CODE: All codes of the referenced products manufactured from June 27,2000 through January 10, 2001. A black and white label on the bottom of the 1/2 gallon plastic containers lists the Julian date of manufacture. REASON: The products bore incomplete ingredients statements. MANUFACTURER/RECALLING FIRM: Superior Dairy, Inc., Canton, OH RECALLED BY: Manufacturer, by telephone on 1/11/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and VA QUANTITY: A total of 35,105 one-half gallon containers as follows: Buehlers-8675; Fishers-1840; Valley Rich Cookies-4120; Valley Rich Blueberry Cobbler- 4275; and Valley Rich Choc Carmel Cashew-6195. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Biscotti in 5 oz. poly bags labeled in part "Seattle Baking COMPANY ** NET WT. 1 oz. SEATTLE, WASHINGTON 98118 ". F-471-1 Traditional Anise F-472-1 Almond F-473-1 Almond Decadence F-474-1 Orange/Almond F-475-1 Hazelnut F-476-1 Hazelnut Decadence F-477-1 Almond Buttercrunch CODE: The 5 oz. packages are not coded. The firm distributes product in a box with other products, and stamps a 30 day expiration date on the box, however, the price and expiration date are applied to the package by the retailer. A 30-day expiration date is recommended by the firm. Expiration dates range from 04-26-01 through 05-16-01. REASON: The products contained undeclared whey. MANUFACTURER/RECALLING FIRM: Seattle Baking Co., South Seattle, WA RECALLED BY: On 4/19/01 the firm telephoned the wholesaler and asked that product be put on hold (the shipment had just been received by the wholesaler). On 4/19/01 the firm began visiting the retail accounts and relabeling the product. Relabeling is complete. FIRM INITIATED RECALL: Complete DISTRIBUTION: Seattle, WA QUANTITY: 917 _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-490-1, E. Wedel Brand Chocolate Covered Gingerbread Cookies with Strawberry Filling, CODE: 7.93 oz. (225 gm) and 5.29 oz. (150 gm) Product is in a plastic bag with printed label in various languages reading in part, ìE. Wedel Pierniczki ALPEJSKIE NADZIENIE TRUSKAWKOWE***" REASON: The product contains the unapproved color additive Ponceau 4R. MANUFACTURER: Danone, Poland RECALLED BY: Cracovia Company LLC, Stamford , CT , by letter on 6/26/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: 6 New England States, NJ and NY. QUANTITY: 310 cases [12bags/case] ______________________________ RECALL NUMBER, PRODUCT AND CODE: The following two (2) beverages are recalled: F-493-1 Caffeine Free Diet Coke, in 2 liter bottles; F-494-1 Coca-Cola Classic, in 20 oz bottles Code Information: Optimum Taste Date Code: 082701TBB REASON: The products have an off odor and off flavor. MANUFACTURER/RECALLING FIRM: Coca-Cola Enterprises, Inc., Twinsburg, OH RECALLED BY: Manufacturer, by e-mail on 6/6/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH, PA, VA, MD, and DE QUANTITY: 20 oz- 14,404 cases; 2 liter- 5,235 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-501-1 Eillien's Ivory Chips, Net Wt. 12 Oz. REASON: The product does not bear a complete ingredient statement. MANUFACTURER: Clasen Quality Coatings, Inc., Middleton, WI RECALLED BY: Eillien's Candies, Inc., Green Bay, WI, by letter 2/26/00. FIRM INITIATED RECALL: Completed DISTRIBUTION: MN, ND, WI QUANTITY: Est. amt. in dist.: 2855 12 oz. packages (total includes product recalled under F-499/500-1 Class I above).RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: D-280-1, Nutrapin AQ [somatropin (rDNA origin) injection] 5mg/ml (2ml/vial), 10 mg per vial. CODE: Lot L9504A3 Exp. Dec 2001 Lot L9504A2 Exp. Apr 2002 REASON: Counterfeit MANUFACTURER/RECALLING FIRM: Unknown RECALLED BY: Mediq, Pennsauken, NJ, by phone on 5/25/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA and GA QUANTITY: 195 cases x 6 unit vials per carton = 1170 unit vials ______________________________ RECALL NUMBER, PRODUCT AND CODE: 1. D-283-1, Regular strength liquid antacid packaged in 1-gal. jugs and 12-fl. oz. bottles, each 5-ml. tsp. contains 200-mg. aluminum hydroxide (equiv. to dried gel, USP), 200-mg. magnesium hydroxide, and 20-mg. simethicone. Product is packaged and distributed in the 12-fl. oz. size under the following labels and sizes: a. York Antacid Liquid with Simethicone Antacid - Anti-Gas Original Flavor, 1-gal. container, Lot 0006052. The responsible firm on the label shows the product is manufactured by York Pharmaceuticals, Inc., Kansas City, KS. b. ShurFine Fast Acting Antacid Anti-Gas Original, 12-fl. oz. bottles, Lot 0003018. Distributed by Shurfine International, Inc., Northlake, IL. c. Dollar General Regular Strength Fast Acting Antacid Liquid Antigas/Antacid Original, 12-fl. oz. bottles, Lot 0006052. Distributed By Dolgencorp, Inc., Scottsville, KY. d. Smart Choice Liquid Antacid Plus Simethicone, 12-fl. oz. bottles, Lot 0006052. Distributed by National Distribution Network, Merrick, NY. 2. D-284-1, Maximum strength liquid antacid packaged in 1-gal. jugs and 12-fl. oz. bottles, each 5-ml. tsp. contains 400-mg. aluminum hydroxide (equiv. to dried gel, USP), 400-mg. magnesium hydroxide, and 40-mg. simethicone, indicated for use in heartburn, acid indigestion, sour stomach, associated symptoms of gas and upset stomach, overindulgence in food and drink. a. York Extra Strength Antacid Suspension with Simethicone Antacid - Anti-Gas Original Flavor, 1-gal. jug, Lot 0006092. Manufactured by York Pharmaceuticals, Inc., Kansas City, KS. b. Rite Aid Fast Acting Antacid & Anti-gas Maximum Strength Original, 12-fl. oz. bottles, Lot 0003048. Distributed by Rite Aid Corporation, Harrisburg, PA. c. Select Brand Maximum Strength Fast Acting Antacid Anti-Gas Original, 12-fl. oz. bottles, Lot 0006092. Distributed by Select Brand Distributing, Pine Bluff, AR. d. Discount Drug Mart Food Fair Maximum Strength Fast Acting Antacid Liquid Original Flavor, 12-fl. oz. bottles, Lot 0006092. Distributed by Drug Mart-Food Fair, Medina, OH. CODE: Lot 0003018, exp. 3/02 Lot 0003048, exp. 3/02 Lot 0006052, exp. 6/02 Lot 0006092, exp. 6/02 REASON: TOTAL AEROBIC MICROBIAL COUNT FAILURES AND LACK OF PRESERVATIVE EFFECTIVENESS TESTING MANUFACTURER/RECALLING FIRM: York Pharmaceuticals, Inc., Kansas City, KS RECALLED BY: Manufacturer, by letters on 6/26/ FIRM INITIATED RECALL: Ongoing DISTRIBUTION: OK, MS, MO, MD, CA, OR, AR, ND, NY, and OH QUANTITY: The following approx. amounts were dist: Lot 0003018 - 965/12/12-fl. oz. btl cs; Lot 0003048 - 260/12/12-fl. oz. btl cs; lot 0006052 - 1,826/12/12-fl. oz. btl cs and 135/4/1-gal. jug cs; lot 0006092 - 502/12/12-fl. oz. btl cs and 132/4/1-gal jug cs _______________________________ RECALL NUMBER, PRODUCT AND CODE: 1) D-285-1, ALUPENT (metaproterenol sulfate USP) Inhalation Solution, 0.4% (10mg/vial) 2) D-286-1, ALUPENT (metaproterenol sulfate USP) Inhalation Solution, 0.6% (15mg/vial); The manufacturer's brand name product is packaged in 25 X 2.5 ml Unit-Dose Vials, under the Boegringer Ingelheim label, NDC #0597-0069-62. 3) D-286-1, METAPROTERENOL Sulfate Inhalation Solution USP, 0.6% (15mg/vial); The generic brand name product is packaged in 25 X 2.5 ml Unit-Dose Vials, under the Roxane Laboratories label, NDC #0054-8614- 11. CODE: ALUPENT 0.4%: Lot Number Exp Date 057144 Jul-02 780508 May-02 780507 Apr-02 780506 Mar-02 780505 Feb-02 780503 Dec-01 780502 Oct-01 ALUPENT 0.6%: Lot Number Exp Date 690552 Nov-02 690551 Aug-02 699554 Oct-01 METAPROTERENOL SULFATE USP 0.6%: Lot Number Exp Date 992862 Oct-01 REASON: LACK OF ASSURANCE OF STERILITY (CGMP DEVIATIONS) MANUFACTURER/RECALLING FIRM: ROXANE LABORATORIES, INC., Columbus, OH. This firm is part of the Boehringer Ingelheim Corporation RECALLED BY: Manufacturer by letter on 8/6/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: OH, KY, AZ, CA, MA, MO, OR, FL, MA, NJ, MN, PA, AL, TX, CO, CT, ID, IL, LA, MS, NY, NC, SC, TN, UT, VA, WA, AK, WI, HI, and NM. QUANTITY: 26,506 boxes / 25 vials each _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-282-1, Diflucan Tablets, 100 mg (Fluconazole Tablets), 30 Tablets CODE: Lot 04P016A, Exp 11/02 REASON: COUNTERFEIT MANUFACTURER/RECALLING FIRM: Unknown RECALLED BY: Rebel Distributors Corp., Westlake Village, CA, FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 7 bottlesRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-268-1, (Rx) Dynabac tablets, delayed release (Dirithromycin) 250 mg, 10 and 60 count, eight various lots REASON: Related substance test failure at stability (12 Month) MANUFACTURER/RECALLING FIRM: Eli Lilly and Company, Indianapolis, IN RECALLED BY: By letter on May 15, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 52,060 ñ60ís 137,832-10ís _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-269-1, White with Blue Specks. The product is sold in 100 count and 500 count bottles. The label states that the product is manufactured for: Pittsburgh Pill Emporium, Pittsburgh, PA or Casey's Distributors, Williamsport, PA. The Casey labeled product is only for the 100 count size. The Pittsburgh Pill labeled product is for both the 100 and 500 count sizes. CODE: Lot #6076 exp. 2/02 REASON: STABILITY: THERE IS NO DATA TO SUPPORT LABELED EXPIRY DATE MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA RECALLED BY: Manufacturer by telephone on 6/27/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: PA QUANTITY: 142 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-270-1, Yellow Rockets Tablets, 200 mg Caffeine. The product is sold in 100 count, 250 count, and 500 count bottles. CODE: Lot 10293 exp. 2/03 REASON: STABILITY: THERE IS NO DATA TO SUPPORT LABELED EXPIRY DATE MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA RECALLED BY: The recalling firm telephoned the account on 6/27/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IA QUANTITY: 1083 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: Perphenazine Tablets,USP, 2mg, 4mg, 8mg, and 16mg Strengths, packaged in 100 and 500 bottles. D-272-1, Perphenazine Tablets,USP, 2mg D-273-1, Perphenazine Tablets,USP, 4 mg D-274-1, Perphenazine Tablets,USP, 8 mg D-275-1, Perphenazine Tablets,USP, 16 mg CODE: Perphenazine Tablets, 2 mg, 4 mg, 8mg, and 16mg strengths: NDC # 0172-3667-60 NDC # 0172-3668-60 NDC # 0172-3669-60 and 0172-3669-70 NDC #0172-3670-60 and 0172-3670-70 Lot Numbers: 2mg: 3667-103; 3667-105; 3667-106; 3667-107; 3667-108, 3667-109 4mg: 3668-153; 3668-154; 3668-155; 3668-156; 3668-157; 3668-158; 3668- 159; 3668-160; 3668-161 8mg: 3669-232; 3669-233; 3669-234; 3669-235; 3669-236; 3669-237; 3669- 238; 3669-239; 3669-240; 3669-241; 3669-242; 3669-243; 3669-244; 3669- 245; 3669-246; 3669-247 16mg: 3670-081; 3670-082; 3670-083; 3670-084 REASON: TABLET DISCOLORATION MANUFACTURER/RECALLING FIRM: Zenith Goldline Pharmaceuticals, Northvale, NJ RECALLED BY: An Urgent Product Recall Letter dated 4/27/ FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 2mg=12,000,000 tablets; 4mg=18,000,000 tablets, 8mg=16,000,000 tablets, 16mg=4,000,000 tablets _______________________________ RECALL NUMBER, PRODUCT AND CODE D-277-1, Cortizone 10 Plus (1% hydrocortisone) CrËme, 1 and 2 ounce tubes CODE: 3 lots involved: 2 oz --- 2400453, exp. 7/2002 1 oz --- 2400452, exp. 7/2002 1 oz --- 2400470, exp. 7/2002 REASON: CONTAMINATION: PRODUCT IS CROSS-CONTAMINATED WITH THE FIRMíS BEN-GAY PRODUCT (METHYL SALICYLATE, MENTHOL, AND CAMPHOR) MANUFACTURER: PFIZER, INC., PARSIPPANY, NJ RECALLED BY: Warner Lambert Consumer Health Care/Pfizer, Inc., Morris Plains, NJ, by letter on May 25, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 441,336 tubesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1566-1, Red Blood Cells, Autologous, units 7583781, 7537250 REASON: Blood products, collected from donors whose hematocrit had not been performed, were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: Manufacturer, by letters dated May 16, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-688-1, VARIOUS CUSTOM SURGICAL PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain Clinipad Products implicated as Class I although the specific lot number included in the kits cannot be determined until they are opened. KIT ITEM # TRAY NAME CLINIPAD ITEM # 82-6616 CRANIAL ACCESS KIT, W/O DRUGS 3943S-B BMH10BW ARTERIAL LINE TRAY 1291SB BMH44MT EYE TRAY 1291SB BX0003 BREAST BIOPSY TRAY 1291SB BXQ007 BREAST BIOPSY PACK 1291SB CH12CO SHOULDER ARTHROSCOP 3943SB CHMC01CO INTERVENTIONAL PACK 3943SB CMC06MF UNIBLOCK-UNIV. NERVE BLOCK 1291SB CTS01D0 RECOVERY TRAY 1241SB CVSCO1MF CATARACT TRAY 1291SB EAP010 LATEX FREE-TYMPANOPLASTY 3943SB ECM01ET ANGIOGRAPHY PACK 3943SB ECMC01ENJ OPHTHALMIC PACK 1291SB EYJ101 EYE PACK 3943SB EYP017 ED JONES EYE TRAY 3943SB EYP071 EYE TRAY 3943SB EYP091 MINI OPHTHALMIC CUSTOM KIT 3943SB GSH0301 VALVE A & B PACK 3943SB GSH04D1 CORONARY TRAY A & B 3943SB GSM065 VASECTOMY PACK 3943SB GSP025 BONE MARROW TRAY 0110 HCL372 ANGIOGRAPHY PACK 3943SB HCP001 CARDIAC CATH PACK 3943SB HMEM01ST CR. TERRELL CATARACT PACK 3942SB MUPO1PP CATARACT PACK 1291SB 1MH12M1 ANESTHESIA BUNDLE CMS 1241SB JPSH29FWT BALLOON INDUCTION TRAY 3943SB MCG05AG PEDIATRIC CARDIAC CATH 3943SB MGH01SW OPHTHALMIC PACK 3943SB M113MA ANGIOGRAPHY TRAY 3943SB M146MA MYLOGRAM 3943SB MMH17BF EYE PACK 3943SB MMH18BF POSTERIOR VITRECTOMY 3943SB MVH22DO LATEX FREE TYMPANOPLASTY 3943SB NNJEO1SONJ BASIC EYE PACK 3943SB OBP049 VAGINAL DELIVERY TRAY 3943SB OLTRMC04CI CATARACT TRAY 3943SB OPP195 PODIATRY SET UP PACK 0110 PLP020 PLASTIC PACK 3943SB RD3548 ELECTRO-PHYSIOLOGY TRAY 3943SB SCH08ECI TOTAL HIP TRAY 3943SB SH01SP CATARACT TRAY 3943SB SHH01CM CATARACT PACK 3943SB SJO7SI BLEEDER SET UP PACK 3943SB SRH01GG CATH PACK 3943SB SRHO1SO DR. ROBINSONíS EYE PACK 3943SB TH11CHI DIALYSIS KIT 0110 THMC12CI P.A.C. KIT 0110 UHCO1CM CATARACT PACK 3943SB VAMCC01CO ANGIO ARTERIOGRAM CV15101 3943SB VAMCC02CO BASIC CATH LAB PK CV15103 3943SB VBH02LV OPEN HEART A/B/C 3943SB WPAFB16WPO PODIATRY PACK PO22001 3943SB REASON: STERILE SURG.KITS MAY CONTAIN NONSTERILE CLINIPAD PRODUCTS MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC., Clearwater, FL RECALLED BY: Manufacturer by letter on 3/30/2000 (dated 3/23/2000) FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 1,000,000 kits potentially with clinipads product. ______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-689-1, Various Sterile Surgical Procedure Trays (custom), Code Information: ALL SURGICAL TRAYS MANUF. AND LABELED WITH MAXXIM MEDICAL OF CLEARWATER FL. ARE COVERED BY THIS RECALL ACTION, ALL PRODUCT NUMBERS AND LOT NUMBERS REASON: STERILE KITS MAY CONTAIN CLINIPAD PRODUCT-LACK OF ASSUR OF STER. MANUFACTURER/RECALLING FIRM: MAXXIM MEDICAL, INC. North Clearwater, FL RECALLED BY: Manufacturer by letter on 3/30/2000 (dated 3/23/2000). FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide to Canada QUANTITY: 1,000,000 kitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-698-1, AcrySofô Brand Intraocular Lenses REASON: Pin holes in the sterile pouches of the intraocular lenses. MANUFACTURER/RECALLING FIRM: ALCON LABORATORIES, Fort Worth, Texas RECALLED BY: Manufacturer by letter on 3/5/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & International QUANTITY: 36,271 Lenses _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-868-1, Sonosite 180 - portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software versions: 01.xx.003.00 to 01.xx.003.067 and 01.xx.002.yyy and 01.xx.001.yyyxx is 40, 60, or 80; and yyy is 000 through 999 REASON: POTENTIAL FOR MISCALCULATION OF ESTIMATED DELIVERY DATE MANUFACTURER/RECALLING FIRM: SONOSITE, INC., Bothell, WA RECALLED BY: The firm notified customers in a letter dated 5/4/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide Military distribution: Bremerton Naval Hospital, Bremerton, WA. QUANTITY: 1,026 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-709-1, H-TRONplus V100 Insulin Infusion Pump REASON: Claim of waterproofing was not cleared MANUFACTURER/RECALLING FIRM: Disetronic Medical Systems, St. Paul, MN RECALLED BY: Manufacturer by letter on 3/4/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 30,000 patients using the pump nationwide. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13) REASON: Motor stall MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS, INC., San Diego, CA RECALLED BY: International mailings are being coordinated by Alaris Medical UK, Ltd. located in Basingstoke, UK. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: International and U.S. Defense Department under contracts V797P-4091A and SP0200-98-D-8002. QUANTITY: 5820 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23 REASON: Software anomaly MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., Tucson AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice PSN-01-L18, June 8, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and DENMARK. QUANTITY: 82 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-736-1, Inflatable Leg compression wraps used to maintain cardiovascular circulation of the legs of a bed-ridden patient. All parts are packed and labeled in part "SISS Inc. Date** Lot # ** Hos Part # ** Part Description: # ** Sisters, OR ** Product has been EO Gas sterilized ***", Inflatable leg compression wraps DVT 30 product - 3574 Z-737-1, Inflatable Leg compression wraps used to maintain cardiovascular circulation of the legs of a bed-ridden patient. All parts are packed and labeled in part "SISS Inc. Date** Lot # ** Hos Part # ** Part Description: # ** Sisters, OR ** Product has been EO Gas sterilized ***", Inflatable leg compression wraps DVT 40 product - 3575 REASON: PRODUCTS ERRONEOUSLY LABELED AS STERILE MANUFACTURER/RECALLING FIRM: Surgical Instrument Service & Savings, Inc., Sisters, OR RECALLED BY: Manufacturer, by telephoned, fax and letter on 5/29/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 15 pkgs (1 pair/pkg) of DVT 30 compression wraps; 6 pkgs (1 pair/pkg) of DVT 40 compression wraps _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0741-1, Intact hCG ELISA Test kit, catalog number KIF4013 CODE: Lots 9906001 and 9907287 REASON: Possible false negative test results MANUFACTURER/RECALLING FIRM: ALEXON - TREND, INC., Ramsey MN RECALLED BY: Manufacturer, by telephone on 10/19/2000, and by letter dated October 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA, MO, NJ and Ireland and Netherlands QUANTITY: 30 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0750-1, Alumi-hand - a sterile, medical device used to immobilize the patient's hand during hand surgeries. Not implanted - single use. Code: Alumi-Hand, large, Stock #760, Lot #I-4284 REASON: Products may not be sterile - not irradiated at proper dose. MANUFACTURER: STRUCKMEYER CORP. Dallas, TX RECALLED BY: INSTRUMENT SPECIALISTS, INC., BOERNE, TX., sent recall letters flagged "URGENT: PRODUCT RECALL" via fax on 4/17/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and US government/military consignees are: Naval Hospital, Portsmouth, VA VA Medical Center, St. Louis, Missouri QUANTITY: 869 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0808-1 to Z-0842-1 Various models and lot numbers of Bausch & Lomb Intraocular Lens Models: Recall number Model Z-0808-1 650CUV, Z-0809-1 6793B, Z-0810-1 8095B, Z-0811-1 8191B, Z-0812-1 8491B, Z-0813-1 8641B, Z-0814-1 95BUV, Z-0815-1 95UV, Z-0816-1 BV359, Z-0817-1 BVR-150S, Z-0818-1 BVR-160M, Z-0819-1 CEN55F, Z-0820-1 EB33B, Z-0821-1 EZE-50, Z-0822-1 FL652F, Z-0823-1 FL65LF, Z-0824-1 IO359, Z-0825-1 MIC6, Z-0826-1 MIC6F, Z-0827-1 P328UV, Z-0828-1 P329UV, Z-0829-1 P337UV, Z-0830-1 P356UV, Z-0831-1 P359UV, Z-0832-1 P366UV, Z-0833-1 P379UV, Z-0834-1 P492UV, Z-0835-1 P499UV, Z-0836-1 P506UV, Z-0837-1 PERLN2, Z-0838-1 PERLN2F, Z-0839-1 PSM3, Z-0840-1 S122UV, Z-0841-1 SIFL2, Z-0842-1 Z130. There are 1639 lot numbers for each model as follows: Model Lot 650CUV 6KV104 650CUV 6KV108 650CUV 6KV109 650CUV 6KV111 650CUV 6KV112 650CUV 6KV114 650CUV Count 6 6793B 6J1K01 6793B 6J1K02 6793B 6J1K03 6793B 6J1K04 6793B 6J1K05 6793B 6J1K06 6793B 6J1K07 6793B 6J1K08 6793B 6J1K10 6793B 6J1K11 6793B 6J1K12 6793B 6KK401 6793B 6KK403 6793B 6KK405 6793B 6KK406 6793B 6KK407 6793B Count 16 8095B 6CXK03 8095B 6CXK10 8095B 6CXK12 8095B 6CXK14 8095B 6CXK16 8095B 6CXN02 8095B 6CXN03 8095B 6CXN07 8095B 6CXN09 8095B 6GN903 8095B 6GN904 8095B 6GN905 8095B 6GPA01 8095B 6GPA02 8095B 6GPA03 8095B 6GPA04 8095B 6GPA05 8095B 6GPA06 8095B 6GPA12 8095B Count 19 8191B 6CJM01 8191B 6CJM03 8191B 6CJM05 8191B 6GPB01 8191B 6GPB02 8191B 6GPB03 8191B 6GPB05 8191B 6GPB06 8191B 6GPB10 8191B 6GPB12 8191B 6GPB16 8191B Count 11 8491B 6CJU03 8491B 6CJU05 8491B 6CJU07 8491B 6CJU08 8491B 6CJU15 8491B 6CJU16 8491B 6CJU18 8491B 6CJU22 8491B 6DLL49 8491B 6DLM01 8491B 6DLM02 8491B 6DLM03 8491B 6DLM04 8491B 6DLM05 8491B 6DLM06 8491B 6DLM07 8491B 6DLM08 8491B 6DLM09 8491B 6DLM10 8491B 6DLM11 8491B 6DLM12 8491B 6DLM13 8491B 6GPC01 8491B Count 23 8641B 6CXX01 8641B 6CXX02 8641B Count 2 95BUV 6DK632 95BUV 6DK633 95BUV 6DK634 95BUV 6DK635 95BUV 6DK636 95BUV 6DK637 95BUV 6KBV33 95BUV 6KBV34 95BUV 6KBV35 95BUV 6KBV36 95BUV 6KBV37 95BUV 6KBV38 95BUV 6KBV39 95BUV 6KBV40 95BUV 6KBV41 95BUV 6KBV42 95BUV 6KBV43 95BUV 6KBV44 95BUV 6KBV45 95BUV 6KBV46 95BUV 6KBV47 95BUV 6KBV48 95BUV 6KBV49 95BUV 6KBV50 95BUV 6KBW01 95BUV 6KBW02 95BUV 6KBW03 95BUV 6KBW04 95BUV 6KBW05 95BUV 6KBW06 95BUV 6KBW08 95BUV 6KBW09 95BUV 6KBW32 95BUV 6KBW33 95BUV 6KBW34 95BUV 6KBW35 95BUV 6KBY02 95BUV 6KBY03 95BUV 6KBY04 95BUV 6KBY05 95BUV 6KBY06 95BUV 6KBY07 95BUV 6KBY08 95BUV 6KBY09 95BUV 6KBY10 95BUV 6KBY11 95BUV 6KBY12 95BUV 6KBY13 95BUV 6KBY14 95BUV 6KBY15 95BUV 6KBY16 95BUV 6KBY17 95BUV 6KBY18 95BUV 6KBY19 95BUV 6KBY20 95BUV 6KBY21 95BUV 6KBY22 95BUV 6KBY23 95BUV 6KBY24 95BUV 6KBY25 95BUV 6KBY26 95BUV 6KBY27 95BUV 6KBY28 95BUV 6KBY29 95BUV 6KBY30 95BUV 6KBY31 95BUV 6KBY32 95BUV 6KBY33 95BUV 6KBY34 95BUV 6KBY35 95BUV 6KBY36 95BUV 6KBY37 95BUV 6KBY38 95BUV 6KBY39 95BUV 6KBY40 95BUV 6KBY41 95BUV 6KBY42 95BUV 6KBY43 95BUV 6KBY44 95BUV 6KBY45 95BUV 6KBY46 95BUV 6KBY47 95BUV 6KBY48 95BUV 6KBY49 95BUV 6KBY50 95BUV 6KBY51 95BUV 6KBY52 95BUV 6KBY53 95BUV 6KBY54 95BUV 6KBY55 95BUV 6KBY56 95BUV 6KBY57 95BUV 6KBY58 95BUV 6KBY59 95BUV 6KBY60 95BUV Count 95 95UV 6KYC01 95UV 6KYC02 95UV 6KYC03 95UV 6KYC04 95UV Count 4 BV359 6D3K01 BV359 6D3K02 BV359 6D3K03 BV359 6D3K04 BV359 6D3K05 BV359 6D3K06 BV359 6D3K07 BV359 6D3K08 BV359 6D3K09 BV359 6D3K10 BV359 6D3K11 BV359 6D3K12 BV359 6D3K13 BV359 6D3K14 BV359 6D3K15 BV359 6D3K16 BV359 6D3K17 BV359 6D3K18 BV359 6D3K19 BV359 6D3K20 BV359 6D3K21 BV359 6D3K22 BV359 6D3K23 BV359 6D3K24 BV359 6D3K25 BV359 6D3K26 BV359 6D3K27 BV359 6D3K28 BV359 6D3K29 BV359 6D3K30 BV359 6D3K32 BV359 6D3K33 BV359 6D3K34 BV359 6D3K35 BV359 6D3K36 BV359 6D3K37 BV359 6D3K38 BV359 6D3K39 BV359 6D3K40 BV359 6D3K41 BV359 6D3K42 BV359 6D3K43 BV359 6D3K44 BV359 6D3K45 BV359 6D3K46 BV359 6D3K47 BV359 6D3K48 BV359 6D3K49 BV359 6D3K52 BV359 6D3K53 BV359 6D3K54 BV359 6D3K55 BV359 6D3K56 BV359 6D3K57 BV359 6D3K58 BV359 6D3K59 BV359 6D3K60 BV359 6D3K61 BV359 6D3K62 BV359 6D3K63 BV359 6D3K64 BV359 6D3K65 BV359 6D3K66 BV359 6D3K67 BV359 6D3K68 BV359 6D3K69 BV359 6D3K70 BV359 6D3K71 BV359 6D3K72 BV359 6D3K73 BV359 6D3K74 BV359 6D3K76 BV359 6D3K77 BV359 6D3K78 BV359 6D3K79 BV359 6D3K80 BV359 6D3K81 BV359 6D3K82 BV359 6D3K83 BV359 6D3K84 BV359 6D3K85 BV359 6D3K86 BV359 6D3K87 BV359 6D3K88 BV359 6D3K89 BV359 6D3K90 BV359 6KC501 BV359 6KC502 BV359 6KC503 BV359 6KC504 BV359 6KC505 BV359 6KC506 BV359 6KC507 BV359 6KC508 BV359 6KC509 BV359 6KC510 BV359 6KC511 BV359 6KC512 BV359 6KC513 BV359 6KC514 BV359 6KC515 BV359 6KC516 BV359 6KC517 BV359 6KCB01 BV359 6KCB02 BV359 6KCB03 BV359 6KCB04 BV359 6KCB05 BV359 6KCB06 BV359 6KCB07 BV359 6KCB08 BV359 6KCB09 BV359 6KCB10 BV359 6KCB11 BV359 6KCB12 BV359 6KCB13 BV359 6KCB14 BV359 6KCB15 BV359 6KCB16 BV359 6KCB17 BV359 6KCB18 BV359 6KCB19 BV359 6KCB20 BV359 6KCB21 BV359 6KCB22 BV359 6KCB23 BV359 6KCB24 BV359 6KCB25 BV359 6KCB26 BV359 6KCB27 BV359 6KCB28 BV359 6KCB29 BV359 6KCB30 BV359 6KCB31 BV359 6KCB32 BV359 6KCB33 BV359 6KCB34 BV359 6KCB35 BV359 6KCB36 BV359 6KCB37 BV359 6KCB38 BV359 6KCB39 BV359 6KCB40 BV359 6KCB41 BV359 6KCB42 BV359 6KCB43 BV359 6KCB44 BV359 6KCB45 BV359 6KCB46 BV359 6KCB47 BV359 6KCB48 BV359 6KCB49 BV359 6KCB50 BV359 6KCB51 BV359 6KCB52 BV359 6KCB53 BV359 6KCB54 BV359 6KCB55 BV359 6KCB56 BV359 6KCB57 BV359 6KCB58 BV359 6KCB59 BV359 6KCB60 BV359 6KCB61 BV359 6KCB62 BV359 6KCB63 BV359 6KCB64 BV359 6KCB65 BV359 6KCB66 BV359 6KCB67 BV359 6KCB68 BV359 6KCB69 BV359 6KCB70 BV359 6KCB71 BV359 6KCB72 BV359 6KCB73 BV359 6KCB74 BV359 6KCB75 BV359 6KCB76 BV359 6KCB77 BV359 6KCB78 BV359 6KCB79 BV359 6KCB80 BV359 6KCB81 BV359 6KCB82 BV359 6KCB83 BV359 6KCB84 BV359 6KCB85 BV359 6KCB86 BV359 6KCB87 BV359 6KCB88 BV359 6KCB89 BV359 6KCR01 BV359 6KCR02 BV359 6KCR03 BV359 6KCR04 BV359 6KCR05 BV359 6KCR06 BV359 6KCR07 BV359 6KCR08 BV359 6KCR09 BV359 6KCR10 BV359 6KCR11 BV359 6KCR12 BV359 6KCR13 BV359 6KCR14 BV359 6KCR15 BV359 6KCR16 BV359 6KCR17 BV359 6KCR18 BV359 6KCR19 BV359 6KDB01 BV359 6KDB02 BV359 6KDB03 BV359 6KDB04 BV359 6KDB05 BV359 6KDB06 BV359 6KDB07 BV359 6KDB32 BV359 6KDB33 BV359 6KDB34 BV359 6KDB35 BV359 6KDB36 BV359 6KDB37 BV359 6KDB38 BV359 6KDB39 BV359 6KDB40 BV359 6KDB41 BV359 6KDB42 BV359 6KDB43 BV359 6KDB44 BV359 6KDB45 BV359 6KDB46 BV359 6KDB47 BV359 6KDB48 BV359 6KDB49 BV359 6KDB50 BV359 6KDB51 BV359 6KDB52 BV359 6KDB53 BV359 6KDB54 BV359 6KDB55 BV359 6KDB56 BV359 6KDB57 BV359 6KDB58 BV359 6KDB59 BV359 6KDB60 BV359 6KDB61 BV359 6KDB62 BV359 6KDB63 BV359 6KDB64 BV359 6KDB65 BV359 6KDB66 BV359 6KDB67 BV359 6KDB68 BV359 6KDB69 BV359 6KDB70 BV359 6KDB71 BV359 6KDB72 BV359 6KDB73 BV359 6KDB74 BV359 6KDB75 BV359 6KDB76 BV359 6KDB77 BV359 6KDB78 BV359 6KDB79 BV359 6KDB80 BV359 6KDB81 BV359 6KDB82 BV359 6KDB83 BV359 6KDB84 BV359 6KDB85 BV359 6KDB86 BV359 6KDB87 BV359 6KDB88 BV359 Count 275 BVR-150S 6KBP34 BVR-150S 6KBP35 BVR-150S 6KBP36 BVR-150S 6KBP37 BVR-150S 6KBP38 BVR-150S 6KBP39 BVR-150S 6KBP40 BVR-150S Count 7 BVR-160M 6GPX01 BVR-160M 6GPX02 BVR-160M 6GPX03 BVR-160M 6GWF01 BVR-160M 6GWF02 BVR-160M 6GWF03 BVR-160M 6GWF04 BVR-160M 6GWF05 BVR-160M 6GWF06 BVR-160M 6GWF07 BVR-160M 6GWF08 BVR-160M 6GWF09 BVR-160M 6GWF11 BVR-160M 6GWF12 BVR-160M 6GWF13 BVR-160M 6GWF14 BVR-160M 6GWF15 BVR-160M 6GWF16 BVR-160M 6GWF17 BVR-160M 6GWF18 BVR-160M 6GWF19 BVR-160M 6GWF20 BVR-160M 6GWF21 BVR-160M 6GWF22 BVR-160M 6GWF23 BVR-160M 6GWF24 BVR-160M 6GWF25 BVR-160M 6GWF26 BVR-160M 6GWF27 BVR-160M 6GWF28 BVR-160M 6GWF29 BVR-160M 6GWF30 BVR-160M 6GWF31 BVR-160M 6GWF32 BVR-160M 6GWF33 BVR-160M 6GWF34 BVR-160M 6GWF35 BVR-160M 6GWF36 BVR-160M 6GWF37 BVR-160M 6GWF38 BVR-160M 6GWF39 BVR-160M 6GWF40 BVR-160M 6GWF41 BVR-160M 6GWF42 BVR-160M 6GWF43 BVR-160M 6GWF44 BVR-160M 6GWF46 BVR-160M 6GWF47 BVR-160M 6GWF48 BVR-160M 6GWF49 BVR-160M 6GWF50 BVR-160M 6GWF51 BVR-160M 6GWF52 BVR-160M 6GWF53 BVR-160M 6GWF54 BVR-160M 6GWF55 BVR-160M 6GWF56 BVR-160M 6GWF57 BVR-160M 6GWF58 BVR-160M 6GWF59 BVR-160M 6GWF60 BVR-160M 6GWF61 BVR-160M 6GWF62 BVR-160M 6GWF63 BVR-160M 6GWF64 BVR-160M 6GWF65 BVR-160M 6GWF66 BVR-160M 6GWF67 BVR-160M 6GWF68 BVR-160M 6GWF69 BVR-160M 6GWF70 BVR-160M 6GWF71 BVR-160M 6GWF72 BVR-160M 6GWF74 BVR-160M 6GWF75 BVR-160M 6GWF76 BVR-160M 6GWF77 BVR-160M 6GWF78 BVR-160M 6GWF79 BVR-160M 6GWF80 BVR-160M 6GWF81 BVR-160M 6GWF82 BVR-160M 6GWF83 BVR-160M Count 83 CEN55F 6C5R66 CEN55F 6C5R67 CEN55F 6C5R68 CEN55F 6C5R69 CEN55F 6C5R70 CEN55F 6C5R71 CEN55F 6C5R72 CEN55F 6C5R74 CEN55F 6C5W01 CEN55F 6C5W02 CEN55F 6C5W03 CEN55F 6C5W04 CEN55F 6C5W05 CEN55F 6C5W06 CEN55F 6C5W07 CEN55F 6C5W08 CEN55F 6C5W09 CEN55F 6C5W10 CEN55F 6C5W11 CEN55F 6C5W12 CEN55F 6C5W13 CEN55F Count 21 EB33B 6KKT02 EB33B 6KKT05 EB33B 6KKT06 EB33B 6KKT07 EB33B 6KKT09 EB33B 6KKT10 EB33B 6KKT11 EB33B 6KKT12 EB33B 6KKT13 EB33B 6KKT14 EB33B Count 10 EZE-50 6J1R01 EZE-50 6J1R02 EZE-50 6J1R03 EZE-50 6J1R04 EZE-50 6J1R05 EZE-50 6J1R06 EZE-50 6J1R07 EZE-50 6J1R09 EZE-50 6J1R10 EZE-50 6J1R11 EZE-50 6J1R12 EZE-50 6J1R13 EZE-50 6J1R14 EZE-50 6J1R15 EZE-50 6J1R18 EZE-50 6J1R19 EZE-50 6J1R20 EZE-50 6LVD01 EZE-50 6LVD02 EZE-50 6LVD03 EZE-50 6LVD04 EZE-50 6LVD05 EZE-50 6LVD06 EZE-50 Count 23 FL652F 6C7C01 FL652F 6C7C02 FL652F 6CUH01 FL652F 6CUH02 FL652F 6CUH03 FL652F 6CUH04 FL652F 6CUH05 FL652F 6CUH06 FL652F 6CUH07 FL652F 6CUH08 FL652F 6CUH09 FL652F Count 11 FL65LF 6CUJ06 FL65LF 6CUJ07 FL65LF Count 2 I0359 6BUT02 I0359 6BUT18 I0359 Count 2 MIC6 6CV901 MIC6 Count 1 MIC6F 6CFL01 MIC6F 6CFL02 MIC6F 6CFL03 MIC6F 6CFL04 MIC6F 6CFL05 MIC6F 6CFL06 MIC6F 6CFL07 MIC6F 6CFL08 MIC6F 6CFL09 MIC6F 6CFL10 MIC6F 6CV703 MIC6F 6CV704 MIC6F 6CV802 MIC6F 6CV803 MIC6F 6CV804 MIC6F 6CV805 MIC6F 6CV806 MIC6F 6CV807 MIC6F 6CV808 MIC6F 6CV809 MIC6F 6CV810 MIC6F 6CV811 MIC6F 6CV812 MIC6F 6CV813 MIC6F 6DAR02 MIC6F 6DAR03 MIC6F 6DAR04 MIC6F 6DAR07 MIC6F 6DAR08 MIC6F 6DAR09 MIC6F 6DAR10 MIC6F 6DAR12 MIC6F 6DAT02 MIC6F 6DAT03 MIC6F 6DAT04 MIC6F 6DAT05 MIC6F 6DAT06 MIC6F 6DAT07 MIC6F 6DAT08 MIC6F 6DAT09 MIC6F 6DAT10 MIC6F 6DAT11 MIC6F 6DAT12 MIC6F 6DAT13 MIC6F 6DAT14 MIC6F 6DAT15 MIC6F 6DAT16 MIC6F 6DAT17 MIC6F 6DAT18 MIC6F 6DAT19 MIC6F 6DAT20 MIC6F 6DAT21 MIC6F 6DAT22 MIC6F 6DAT23 MIC6F 6DAT24 MIC6F 6DAT25 MIC6F 6DAT26 MIC6F 6DAT27 MIC6F 6DAT28 MIC6F 6DAT29 MIC6F 6DAT30 MIC6F 6DAT31 MIC6F 6DAT32 MIC6F 6DAT33 MIC6F 6DAT34 MIC6F 6DAT35 MIC6F 6DAT36 MIC6F 6DAT37 MIC6F 6DAT38 MIC6F 6DAT69 MIC6F 6DAT70 MIC6F 6DAT71 MIC6F 6DAT72 MIC6F 6DAT73 MIC6F 6DAT74 MIC6F 6DAT76 MIC6F 6DAT77 MIC6F 6DAT78 MIC6F 6DAT79 MIC6F 6DAT80 MIC6F 6DAT81 MIC6F 6DAT82 MIC6F 6DAT83 MIC6F 6DAT84 MIC6F 6DAT85 MIC6F 6DAT86 MIC6F 6DAT87 MIC6F 6DAT88 MIC6F 6DAT89 MIC6F 6DAT90 MIC6F 6DAT91 MIC6F 6DAT94 MIC6F 6DAW01 MIC6F 6DAW02 MIC6F 6DAW33 MIC6F 6DAW34 MIC6F 6DAW35 MIC6F 6DAW36 MIC6F 6DAW37 MIC6F 6DAW38 MIC6F 6DAW39 MIC6F 6DAW40 MIC6F 6DAW41 MIC6F 6DAW42 MIC6F 6DAW43 MIC6F 6DAW44 MIC6F 6DAW45 MIC6F 6DAW46 MIC6F 6DAW47 MIC6F 6DAW48 MIC6F 6DAW49 MIC6F 6DAW50 MIC6F 6DAW51 MIC6F 6DAW52 MIC6F 6DAW53 MIC6F 6DAW54 MIC6F 6DAW55 MIC6F 6DAW56 MIC6F Count 118 P328UV 6JAG01 P328UV 6JAG02 P328UV 6JAG03 P328UV 6JAG04 P328UV 6JAG05 P328UV 6JAG06 P328UV 6JAG07 P328UV 6JAG08 P328UV 6JAG09 P328UV 6JAG10 P328UV 6JAG11 P328UV 6JAG12 P328UV 6JAG13 P328UV 6KC701 P328UV 6KC702 P328UV 6KC703 P328UV 6KC704 P328UV 6KC705 P328UV 6KC706 P328UV 6KC707 P328UV 6KC708 P328UV 6KC709 P328UV 6KC710 P328UV 6KC711 P328UV 6KC712 P328UV 6KC713 P328UV 6KC714 P328UV 6KC715 P328UV 6KCW01 P328UV 6KCW02 P328UV 6KCW03 P328UV 6KCW04 P328UV 6KCW05 P328UV 6KCW06 P328UV 6KCW07 P328UV 6KCW08 P328UV 6KCW09 P328UV 6KCW10 P328UV 6KCW11 P328UV 6KCW12 P328UV 6KCW13 P328UV Count 41 P329UV 6MFM01 P329UV 6MFM02 P329UV 6MFM03 P329UV 6MFM04 P329UV 6MFM05 P329UV 6MFM06 P329UV 6MFM07 P329UV 6MFM11 P329UV 6MFM12 P329UV 6MFM13 P329UV 6MFM14 P329UV 6MFN33 P329UV 6MFN34 P329UV 6MFN35 P329UV 6MFN36 P329UV 6MFN37 P329UV 6MFN38 P329UV 6MFN39 P329UV 6MFN40 P329UV 6MFN41 P329UV 6MFN42 P329UV 6MFN43 P329UV 6MFN44 P329UV 6MFN45 P329UV 6MFN46 P329UV 6MFN47 P329UV 6MFN48 P329UV 6MFN49 P329UV 6MFN50 P329UV 6MFN51 P329UV 6MFN52 P329UV 6MFN53 P329UV 6MFN54 P329UV 6MFN55 P329UV 6MFN56 P329UV 6MFN57 P329UV 6MFN58 P329UV 6MFN59 P329UV 6MFN60 P329UV 6MFN61 P329UV 6MFN62 P329UV 6MFN63 P329UV 6MFN64 P329UV 6MFN65 P329UV 6MFN66 P329UV 6MFN67 P329UV 6MFN68 P329UV 6MFN69 P329UV 6MFN70 P329UV 6MFN71 P329UV 6MFN72 P329UV 6MFU01 P329UV 6MFU02 P329UV 6MFU03 P329UV 6MFU04 P329UV 6MFU05 P329UV 6MFU06 P329UV 6MFU07 P329UV 6MFU08 P329UV 6MFU09 P329UV 6MFU10 P329UV 6MFW01 P329UV 6MFW02 P329UV 6MFW03 P329UV 6MFW04 P329UV 6MFW05 P329UV 6MFW06 P329UV 6MFW07 P329UV 6MFW08 P329UV 6MFW09 P329UV 6MFW10 P329UV 6MFW11 P329UV 6MFW12 P329UV 6MFW15 P329UV 6MFW16 P329UV 6MFW17 P329UV Count76 P337UV 6KB001 P337UV 6KB002 P337UV 6KB003 P337UV 6KB004 P337UV 6KB005 P337UV 6KB006 P337UV 6KB007 P337UV 6KB008 P337UV 6KB009 P337UV 6KB010 P337UV 6KB011 P337UV 6KB012 P337UV 6KB013 P337UV 6KB014 P337UV 6KB015 P337UV 6KB016 P337UV 6KB017 P337UV 6KB033 P337UV 6KB034 P337UV 6KB035 P337UV 6KB036 P337UV 6KB037 P337UV 6KB038 P337UV Count 23 P356UV 6CF118 P356UV 6CF119 P356UV Count 2 P359UV 6KB401 P359UV 6KB464 P359UV 6KB465 P359UV 6KB466 P359UV 6KB467 P359UV 6KB468 P359UV 6KB469 P359UV 6KB470 P359UV 6KB471 P359UV 6KB472 P359UV 6KB473 P359UV 6KB474 P359UV 6KC401 P359UV 6KC402 P359UV 6KC405 P359UV 6KC406 P359UV 6KC407 P359UV 6KC408 P359UV 6KC409 P359UV 6KC410 P359UV 6KC411 P359UV 6KC412 P359UV Count 22 P366UV 6CGP01 P366UV 6CWX02 P366UV 6CWX05 P366UV 6CWX06 P366UV 6CWX07 P366UV 6CWX09 P366UV 6CWX13 P366UV 6CWX22 P366UV 6CWX23 P366UV 6CWX24 P366UV 6CWX25 P366UV 6CWX26 P366UV 6CWX28 P366UV 6CWX35 P366UV 6CWX40 P366UV 6CWX46 P366UV Count 16 P379UV 6DXC32 P379UV 6DXC33 P379UV 6DXC34 P379UV 6DXC35 P379UV 6DXC36 P379UV 6DXC37 P379UV 6DXC38 P379UV 6DXC39 P379UV Count 8 P492UV 6KC801 P492UV 6KC802 P492UV 6KC803 P492UV 6KC804 P492UV 6KC805 P492UV 6KC806 P492UV 6KC807 P492UV 6KC808 P492UV 6KC809 P492UV 6KC810 P492UV 6KC811 P492UV 6KC812 P492UV 6KC813 P492UV 6KC815 P492UV 6KC816 P492UV 6KC817 P492UV 6KC818 P492UV 6KC819 P492UV 6KC820 P492UV 6KC821 P492UV 6KC822 P492UV 6KC823 P492UV 6KC832 P492UV 6KC833 P492UV 6KC834 P492UV 6KC835 P492UV 6KC836 P492UV 6KC837 P492UV 6KC838 P492UV 6KC839 P492UV 6KC840 P492UV 6KCY01 P492UV 6KCY02 P492UV 6KCY03 P492UV 6KCY05 P492UV 6KCY06 P492UV 6KCY07 P492UV 6KCY08 P492UV 6KCY09 P492UV 6KCY10 P492UV 6KCY11 P492UV 6KCY12 P492UV 6KCY13 P492UV Count 43 P499UV 6DBL01 P499UV 6DBL02 P499UV 6KC201 P499UV Count 3 P506UV 6ETY01 P506UV 6ETY04 P506UV 6ETY07 P506UV 6ETY08 P506UV 6ETY10 P506UV 6ETY11 P506UV 6ETY12 P506UV 6ETY14 P506UV 6ETY16 P506UV 6ETY20 P506UV 6ETY21 P506UV 6ETY22 P506UV 6ETY24 P506UV 6ETY25 P506UV 6ETY28 P506UV 6J1J01 P506UV 6J1J02 P506UV 6J1J03 P506UV 6J1J04 P506UV 6KWJ01 P506UV 6KWJ02 P506UV Count 21 PERLN2 6CWD01 PERLN2 6CWD02 PERLN2 6CWD03 PERLN2 6CWD04 PERLN2 6CWD05 PERLN2 6CWD06 PERLN2 6CWD07 PERLN2 6CWD10 PERLN2 6CWD12 PERLN2 6CWE01 PERLN2 6CWE02 PERLN2 6CWE03 PERLN2 6CWE04 PERLN2 6CWE05 PERLN2 6CWE06 PERLN2 6CWE07 PERLN2 6DBG01 PERLN2 6DBG02 PERLN2 6DBG07 PERLN2 6DBG08 PERLN2 6DBG11 PERLN2 6DBG13 PERLN2 6DBH01 PERLN2 6DBH02 PERLN2 6DBH03 PERLN2 6DBH04 PERLN2 6DBH05 PERLN2 6DBH06 PERLN2 6DBH07 PERLN2 6DBH08 PERLN2 6DBH09 PERLN2 6DBH11 PERLN2 6DBH13 PERLN2 6DBH14 PERLN2 6DBH15 PERLN2 6DBH16 PERLN2 6DBH17 PERLN2 6DBK01 PERLN2 6DBK06 PERLN2 6KXW01 PERLN2 6KXY01 PERLN2 6KXY03 PERLN2 Count 42 PERLN2F 6CWA01 PERLN2F 6CWA02 PERLN2F 6CWA03 PERLN2F 6CWA04 PERLN2F 6CWA05 PERLN2F 6CWA06 PERLN2F 6CWA07 PERLN2F 6CWA08 PERLN2F 6CWA09 PERLN2F 6CWA10 PERLN2F 6CWC01 PERLN2F 6DA836 PERLN2F 6DA837 PERLN2F 6DA838 PERLN2F 6DA839 PERLN2F 6DA843 PERLN2F 6DA845 PERLN2F 6DA846 PERLN2F 6DA847 PERLN2F 6DA848 PERLN2F 6DA849 PERLN2F 6DA850 PERLN2F 6DA851 PERLN2F 6DA852 PERLN2F 6DA853 PERLN2F 6DA854 PERLN2F 6DA855 PERLN2F 6DA856 PERLN2F 6DA857 PERLN2F 6DA860 PERLN2F 6DA861 PERLN2F Count 31 PSM3 1001808001 PSM3 1001808002 PSM3 1001808003 PSM3 1001808004 PSM3 1001808005 PSM3 1001808006 PSM3 1001808007 PSM3 1001808008 PSM3 1001808009 PSM3 1001808010 PSM3 1001808011 PSM3 1001808012 PSM3 1001808013 PSM3 1001808014 PSM3 1001808015 PSM3 1001808016 PSM3 1001808017 PSM3 1001808018 PSM3 1001808033 PSM3 1001808034 PSM3 1001808035 PSM3 1001808036 PSM3 1001808037 PSM3 1001808038 PSM3 1001808039 PSM3 1001808040 PSM3 1001808041 PSM3 1001808042 PSM3 1001808043 PSM3 1001808044 PSM3 1001808045 PSM3 1001808046 PSM3 1001808047 PSM3 1001808048 PSM3 1001808049 PSM3 1001808050 PSM3 1001808051 PSM3 1001808052 PSM3 1001808053 PSM3 1001808054 PSM3 1001808055 PSM3 1001808056 PSM3 1001808058 PSM3 1001808059 PSM3 1001808060 PSM3 1001808061 PSM3 1001808062 PSM3 1001808063 PSM3 1001808064 PSM3 1001808065 PSM3 1001812001 PSM3 1001812002 PSM3 1001812003 PSM3 1001812004 PSM3 1001812005 PSM3 1001812006 PSM3 1001812007 PSM3 1001812008 PSM3 1001812009 PSM3 1001812010 PSM3 1001812011 PSM3 1001812012 PSM3 1001812013 PSM3 1001812014 PSM3 1001812015 PSM3 1001812016 PSM3 1001812017 PSM3 1001812018 PSM3 1001812019 PSM3 1001812020 PSM3 1001812021 PSM3 1001812022 PSM3 1001812023 PSM3 1001812024 PSM3 1001812025 PSM3 1001812026 PSM3 1001812027 PSM3 1001812028 PSM3 1001812029 PSM3 1001812030 PSM3 1001812031 PSM3 1001812032 PSM3 1001812033 PSM3 1001812034 PSM3 1001812035 PSM3 1001812036 PSM3 1001812037 PSM3 1001815001 PSM3 1001815002 PSM3 1001815003 PSM3 1001815004 PSM3 1001815005 PSM3 1001815006 PSM3 1001815007 PSM3 1001815008 PSM3 1001815009 PSM3 1001815010 PSM3 1001815011 PSM3 1001815012 PSM3 1001815013 PSM3 1001815014 PSM3 1001815015 PSM3 1001815016 PSM3 1001815017 PSM3 1001815018 PSM3 1001815019 PSM3 1001815020 PSM3 1001815021 PSM3 1001815022 PSM3 1001815023 PSM3 1001815024 PSM3 1001815025 PSM3 1001815026 PSM3 1001815027 PSM3 1001815028 PSM3 1001815029 PSM3 1001815030 PSM3 1001815031 PSM3 1001815032 PSM3 1001815033 PSM3 1001815034 PSM3 1001815035 PSM3 1001815036 PSM3 1001815037 PSM3 1001815038 PSM3 1001815039 PSM3 1001815040 PSM3 1001815041 PSM3 1001815042 PSM3 1001815043 PSM3 1001815044 PSM3 1001815045 PSM3 1001815046 PSM3 1001815047 PSM3 1001815048 PSM3 1001815049 PSM3 1001815050 PSM3 1001815051 PSM3 1001815052 PSM3 1001815053 PSM3 1001815055 PSM3 1001815056 PSM3 1001815057 PSM3 1001815058 PSM3 1001815059 PSM3 1001815060 PSM3 1001815061 PSM3 1001815062 PSM3 1001815063 PSM3 1001815064 PSM3 1001815065 PSM3 1001815066 PSM3 1001815067 PSM3 1001815068 PSM3 1001815069 PSM3 1001815070 PSM3 1001815071 PSM3 1001815072 PSM3 1001815073 PSM3 1001815074 PSM3 1001815075 PSM3 1001815076 PSM3 1001815077 PSM3 1001815078 PSM3 1001815079 PSM3 1001815080 PSM3 1001815081 PSM3 1001815082 PSM3 1001815083 PSM3 1001815084 PSM3 1001815085 PSM3 1001815086 PSM3 1001815087 PSM3 1001815088 PSM3 1001815089 PSM3 1001815090 PSM3 1001817001 PSM3 1001817002 PSM3 1001817003 PSM3 1001817004 PSM3 1001817005 PSM3 1001817006 PSM3 1001817007 PSM3 1001817008 PSM3 1001817009 PSM3 1001817010 PSM3 1001817011 PSM3 1001817012 PSM3 1001817013 PSM3 1001817014 PSM3 1001817015 PSM3 1001817016 PSM3 1001817017 PSM3 1001817018 PSM3 1001817019 PSM3 1001817020 PSM3 1001817021 PSM3 1001817022 PSM3 1001817023 PSM3 1001817024 PSM3 1001817025 PSM3 1001817026 PSM3 1001817027 PSM3 1001817028 PSM3 1001817029 PSM3 1001817030 PSM3 1001817031 PSM3 1001817032 PSM3 1001817033 PSM3 1001817034 PSM3 1001817035 PSM3 1001817036 PSM3 1001817037 PSM3 1001817038 PSM3 1001817039 PSM3 1001817040 PSM3 1001817041 PSM3 1001817042 PSM3 1001817043 PSM3 1001817044 PSM3 1001817045 PSM3 1001817046 PSM3 1001817047 PSM3 1001817048 PSM3 1001817049 PSM3 1001817050 PSM3 1001817051 PSM3 1001817052 PSM3 1001817053 PSM3 1001817054 PSM3 1001817055 PSM3 1001817056 PSM3 1001817057 PSM3 1001817058 PSM3 1001817059 PSM3 1001817060 PSM3 1001817061 PSM3 1001817062 PSM3 1001817063 PSM3 1001817064 PSM3 1001817065 PSM3 1001817066 PSM3 1001817067 PSM3 1001817068 PSM3 1001817069 PSM3 1001817070 PSM3 1001817071 PSM3 1001817072 PSM3 1001817073 PSM3 1001817074 PSM3 1001817075 PSM3 1001817076 PSM3 1001817077 PSM3 1001817078 PSM3 1001817079 PSM3 1001817080 PSM3 1001817081 PSM3 1001817082 PSM3 1001817083 PSM3 1001817084 PSM3 1001817085 PSM3 1001817086 PSM3 1001817087 PSM3 1001817088 PSM3 1001817089 PSM3 1001817090 PSM3 1001817091 PSM3 1001820002 PSM3 1001820003 PSM3 1001820006 PSM3 1001820007 PSM3 1001820009 PSM3 1001820010 PSM3 1001820011 PSM3 1001820012 PSM3 1001820013 PSM3 1001820014 PSM3 1001820015 PSM3 1001820016 PSM3 1001820017 PSM3 1001820018 PSM3 1001820019 PSM3 1001820020 PSM3 1001820021 PSM3 1001823001 PSM3 1001823002 PSM3 1001823003 PSM3 1001823004 PSM3 1001823005 PSM3 1001823006 PSM3 1001823007 PSM3 1001823008 PSM3 1001823009 PSM3 1001823010 PSM3 1001823011 PSM3 1001823012 PSM3 1001823013 PSM3 1001823014 PSM3 1001823015 PSM3 1001823016 PSM3 1001823017 PSM3 1001823018 PSM3 1001823019 PSM3 1001823020 PSM3 1001823021 PSM3 1001823022 PSM3 1001823023 PSM3 1001823024 PSM3 1001823025 PSM3 1001823026 PSM3 1001823027 PSM3 1001823028 PSM3 1001823029 PSM3 1001823030 PSM3 1001823031 PSM3 1001823032 PSM3 1001823033 PSM3 1001823034 PSM3 1001823035 PSM3 1001823036 PSM3 1001823037 PSM3 1001823038 PSM3 1001829001 PSM3 1001829002 PSM3 1001829003 PSM3 1001829004 PSM3 1001829005 PSM3 1001829006 PSM3 1001829007 PSM3 1001829008 PSM3 1001829009 PSM3 1001829010 PSM3 1001829011 PSM3 1001829012 PSM3 1001829013 PSM3 1001829014 PSM3 1001829015 PSM3 1001829016 PSM3 1001829017 PSM3 1001829018 PSM3 1001829019 PSM3 1001829020 PSM3 1001829021 PSM3 1001829022 PSM3 1001829023 PSM3 1001829024 PSM3 1001829025 PSM3 Count 347 S122UV 6CXF01 S122UV 6CXF03 S122UV 6CXF04 S122UV 6CXF05 S122UV 6CXF06 S122UV 6CXF07 S122UV 6CXF08 S122UV 6CXF09 S122UV 6CXF10 S122UV 6CXF11 S122UV 6CXF12 S122UV 6CXF13 S122UV 6CXF14 S122UV 6CXF15 S122UV 6CXF16 S122UV 6CXF17 S122UV 6CXF18 S122UV 6CXF19 S122UV 6CXF20 S122UV 6CXF21 S122UV 6CXF22 S122UV 6CXF23 S122UV 6CXF24 S122UV 6CXF25 S122UV 6CXF26 S122UV 6CXF27 S122UV 6CXF28 S122UV 6CXF29 S122UV 6CXF30 S122UV 6CXF31 S122UV 6CXF32 S122UV 6CXF33 S122UV 6CXF34 S122UV 6CXF35 S122UV 6CXF36 S122UV 6CXF37 S122UV 6CXF38 S122UV 6CXF39 S122UV 6CXF40 S122UV 6CXF41 S122UV 6CXF42 S122UV 6CXF43 S122UV 6CXF44 S122UV 6CXF45 S122UV 6CXF46 S122UV 6CXF49 S122UV 6CXF50 S122UV 6CXF51 S122UV 6CXF54 S122UV 6CXF55 S122UV 6CXF57 S122UV 6CXF59 S122UV 6CXF60 S122UV 6CXF61 S122UV 6CXF62 S122UV 6CXF63 S122UV 6CXF65 S122UV 6CXF66 S122UV 6CXF67 S122UV 6CXF70 S122UV 6CXF72 S122UV 6CXF73 S122UV 6CXF74 S122UV 6CXF75 S122UV 6CXF76 S122UV 6CXF79 S122UV 6CXF81 S122UV 6CXF82 S122UV 6DXK01 S122UV 6DXK03 S122UV 6DXK04 S122UV 6DXK05 S122UV 6DXK06 S122UV 6DXK07 S122UV 6DXK08 S122UV 6DXK10 S122UV 6DXK11 S122UV 6DXK12 S122UV 6DXK13 S122UV 6DXK15 S122UV 6DXK16 S122UV 6DXK17 S122UV 6DXK18 S122UV 6DXK19 S122UV 6DXK20 S122UV 6DXK21 S122UV 6DXK22 S122UV 6DXK23 S122UV 6DXK24 S122UV 6DXK25 S122UV 6DXK26 S122UV 6DXK27 S122UV 6DXK28 S122UV 6DXK30 S122UV 6DXK43 S122UV 6DXK44 S122UV 6DXK45 S122UV 6DXK46 S122UV 6DXK47 S122UV 6DXK48 S122UV 6DXK49 S122UV 6DXK50 S122UV 6DXK51 S122UV 6DXK52 S122UV 6DXK53 S122UV 6DXK55 S122UV 6DXM01 S122UV 6DXM02 S122UV 6DXM03 S122UV 6DXM05 S122UV 6DXM06 S122UV 6DXM07 S122UV 6DXM08 S122UV 6DXM09 S122UV 6DXM10 S122UV 6DXM11 S122UV 6DXM12 S122UV 6DXM13 S122UV 6DXM14 S122UV 6DXM15 S122UV 6DXM16 S122UV 6DXM17 S122UV 6DXM18 S122UV 6DXM19 S122UV 6DXM21 S122UV 6DXP01 S122UV 6DXP02 S122UV 6DXP03 S122UV 6DXP04 S122UV 6DXP05 S122UV 6DXP06 S122UV 6DXP07 S122UV 6DXP08 S122UV 6DXP11 S122UV 6DXP12 S122UV 6DXP13 S122UV 6DXP14 S122UV 6DXP15 S122UV 6DXP16 S122UV 6DXP17 S122UV 6DXP18 S122UV 6DXP19 S122UV 6DXP21 S122UV 6DXP22 S122UV 6DXP24 S122UV 6DXP25 S122UV 6DXP26 S122UV 6DXP27 S122UV 6DXP28 S122UV 6DXR01 S122UV 6DXR02 S122UV 6DXR03 S122UV 6DXR04 S122UV 6DXR05 S122UV 6DXR06 S122UV 6DXR07 S122UV 6DXR08 S122UV 6DXR09 S122UV 6DXR10 S122UV 6DXR11 S122UV 6DXR12 S122UV 6DXR13 S122UV 6DXR14 S122UV 6DXR15 S122UV 6DXR16 S122UV 6DXR17 S122UV 6KDL01 S122UV 6KDL02 S122UV 6KDL03 S122UV 6KDL04 S122UV 6KDL05 S122UV 6KDL06 S122UV 6KDL07 S122UV 6KDL08 S122UV 6KDL09 S122UV 6KDL10 S122UV 6KDL11 S122UV 6KDL12 S122UV 6KDL13 S122UV 6KDL14 S122UV 6KDL15 S122UV 6KDL16 S122UV 6KDL17 S122UV 6KDL18 S122UV 6KDL19 S122UV 6KDL20 S122UV 6KDL21 S122UV 6KDL22 S122UV 6KDL23 S122UV 6KDL24 S122UV 6KDL25 S122UV 6KDL26 S122UV 6KDL27 S122UV 6KDL28 S122UV 6KDL29 S122UV 6KDL30 S122UV 6KDL31 S122UV 6KDL32 S122UV 6KDL33 S122UV 6KDL34 S122UV 6KDL35 S122UV 6KDL36 S122UV 6KDL38 S122UV 6KDL41 S122UV 6KDL42 S122UV 6KDL43 S122UV 6KDL44 S122UV 6KDL45 S122UV 6KDL46 S122UV 6KDL47 S122UV 6KDL48 S122UV 6KDM01 S122UV 6KDM02 S122UV 6KDM03 S122UV 6KDM04 S122UV 6KDM05 S122UV 6KDM06 S122UV 6KDM07 S122UV 6KDM08 S122UV 6KDM09 S122UV 6KDM10 S122UV 6KDM11 S122UV 6KDM12 S122UV 6KDM13 S122UV 6KDM14 S122UV 6KDM15 S122UV 6KDM16 S122UV 6KDM17 S122UV 6KDM18 S122UV 6KDM19 S122UV 6KDM20 S122UV Count 231 SIFL2 6EWF97 SIFL2 6EWF98 SIFL2 Count 2 Z130 6KKU01 Z130 6KKU02 Z130 Count 2 Grand Count 1639 REASON: Possible compromise of sterility packaging barriers. MANUFACTURER/RECALLING FIRM: BAUSCH & LOMB SURGICAL, INC., North Clearwater, FL RECALLED BY: Manufacturer, by MEDICAL DEVICE RECALL Notification Letter on May 24, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, International QUANTITY: 1639 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0749-1, Impervious Labeled, Internally-Reinforced UltraGard Gowns - The affected gowns are labeled as "single use only." The following products/labels are under recall: Ref. 22321 - X-Lg Impervious Reinforced Gown Ref. 33311 - Large Impervious Reinforced Gown Reorder No. 33311 - Large O.R. Gown Ref. 33321 - X-Large Impervious Reinforced Gown Reorder No. 33321 - X-Large O.R. Gown Ref. 33331 - XX-Large Impervious Reinforced Gown Reorder No. 33331 - XX-Large O.R. Gown Ref. 33950 - Lg Impervious Reinforced Gown Reorder No. 33950 - Large O.R. Gown Ref. 33960 - X-Lg Impervious Reinforced Gown Reorder No. 33960 - X-Large O.R. Gown Reorder No. 33970 - X-Large X-Long O.R. Gown Reorder No. 44062 - Arthroscopy Pack Reorder No. 44110 - Basic Pack Reorder No. 44116 - Basic Pack Reorder No. 44223 - Laparotomy Pack Reorder No. 44224 - Laparotomy Pack Reorder No. 44460 - Shoulder Arthroscopy Pack Reorder No. 44464 - Hip Pack Reorder No. 44465 - General Orthopedic Pack Reorder No. 44466 - Hip Pack Reorder No. 44468 - Arthroscopy Pack Reorder No. 44469 - Extremity Pack Reorder No. 44473 - CV Pack Reorder No. 44481 - Arthroscopy Pack Reorder No. 44541 - Lithotomy Pack IV Reorder No. 44773 - E.E.N.T. Ultra Pack Reorder No. 44775 - CV Pack Reorder No. 44787 - Femoral Angio Pack Reorder No. 45118 - Scoleosis Pack Reorder No. 47777 - Femoral Angio Pack Ref. 70311 - Large Zoned Impervious Gown Ref. 70321 - X-Lg Zoned Impervious Gown Ref. 92039 - Large Ultragard Impervious Reinforced Gown Reorder No. 92039 - Large O.R. Gown Ref. 92043 - X-Lg Zoned Impervious Gown Reorder No. 92043 - X-Large O.R. Gown Ref. 92046 - XX-Lg Zoned Impervious Gown Reorder No. 92046 - XX-Large O.R Gown Ref. 95311 - Large Zoned Impervious Gown Reorder No. 95311 - Large O.R. Gown Ref. 95321 - X-Lg Zoned Impervious Gown Reorder no. 95321 - X-Large O.R. Gown Ref. 95331 - XX-Lg Zoned Imperious Gown Reorder No., 95331 - XX-large O.R. Gown Ref. 16-8950 - Lge Impervious Reinforced Gown Ref. 16-8960 X-Lg Impervious Reinforced Gown Some of the products are for bulk, non-sterile components that are intended for use in finished surgical kit devices made by others. Code: 992710, 992870, 992920, 992950, 993000, 993010, 993140, 993200, 993210, 993230, 993300, 993420, 993430, 993490, 993510, 1000050, 1000120, 1000190, 1000200, 1000250, 1000260, 1000270, 1000310, 1000350, 1000410, 1000450, 1000470, 1000480, 1000540, 1000660, 1000670, 1000680, 1000690, 1000700, 1000740, 1000750, 1000760, 1000770, 1000840, 1000880, 1000910, 1000970, 1000980, 1000990, 1000970, 1000980, 1000990, 1001020, 1001030, 1001040, 1001050, 1001060, 1001080, 1001090, 1001100, 1001160, 1001170, 1001180, 1001240, 1001250, 1001290, 1001300, 1001330, 1001390, 1001400, 1001430, 1001440, 1001450, 1001460, 1001470, 1001500, 1001510, 1001520, 1001530, 1001580, 1001590, 1001600, 1001610, 1001650, 1001660, 1001670, 1001680, 1001710, 1001720, 1001730, 1001740, 1001750, 1001780, 1001790, 1001800, 1001820, 1001850, 1001860, 1001870, 1001890, 1001920, 1001930, 1001960, 1002010, 1002020, 1002030, 1002070, 1002080, 1002100, 1002130, 1002140, 1002150, 1002160, 1002170, 1002210, 1002230, 1002240, 1002270, 1002290, 1002300, 1002310, 1002340, 1002350, 1002360, 1002370, 1002380, 1002420, 1002430, 1002440, 1002450, 1002480, 1002500, 1002520, 1002550, 1002560, 1002580, 1002630, 1002640, 1002650, 1002660, 1002690, 1002700, 1002710, 1002760, 1002780, 1002790, 1002800, 1002840, 1002860, 1002870, 1002910, 1002920, 1002930, 1002990, 1003000, 1003010, 1003040, 1003050, 1003060, 1003070, 1003100, 1003120, 1003130, 1003140, 1003150, 1003180, 1003190, 1003200, 1003220, 1003270, 1003280, 1003290, 1003320, 1003350 REASON: Gowns may not be impervious MANUFACTURER/RECALLING FIRM: White Knight Healthcare, NC RECALLED BY: Manufacturer, by letter on 1/31/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 230,216 gowns or gown packs _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0768-1, gas machine for anesthesia, Code: 4114586-001 REASON: Reports of unintended PEEP greater than 20 cmH2O, all occurring at same hospital MANUFACTURER/RECALLING FIRM: NORTH AMERICAN DRAGER, Telford, PA RECALLED BY: The recalling firm has contracted the services of NNC to print their recall letter and mail via UPS. The recall letter is being sent to all direct accounts. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Canada QUANTITY: 464 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0869-1 Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, CODE: Catalog Number SC1163-5052 Lot 3559- 071800 Z-0870-1, 1Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, Catalog Number SC1163-5860 Lot 3600-071800 Z-0871-1, 1Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, Catalog Number SC1586-3-10 Lot 3594-071800 REASON: Overlapped seal MANUFACTURER/RECALLING FIRM: STELKAST CO., Pittsburgh, PA RECALLED BY: Manufacturer, via telephone on 2/14/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, MI, NC, NY, OH, and PA QUANTITY: 57 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0880-1, 7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set, Code Information: Catalog # MCTC730K, Lot #M029230 REASON: Mislabeled - incorrect priming volume MANUFACTURER/RECALLING FIRM: MEDICAL COMPONENTS, INC., Harleysville, PA RECALLED BY: Manufacturer, by letter via fax on 1/19/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL, IL, MO, NJ, PR, and TX QUANTITY: 91 Trays _______________________________ RECALL NUMBER, PRODUCT AND CODE: MEDCOMP BIO-FLEX CS CATHETER (CS100) Z-0881-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFL-6 - lots: M813770, M819200, M820840, M902950, M903840, M907780, M915320, M919550, M921320, M929930, M933270 and M936870. Z-0882-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFL-6CTT (left side) - lots: M912540, M919140, M932310 and M934780. Z-0883-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFR-6CTT (right side) - lots: M912550, M915330, M919130, M924550, M932320, M935480, and M937950. Z-0884-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFR-6 - lots: M728810, M801970, M809360, M813780, M819050, M819980, M820830, M900800, M902960, M903830, M904290, M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450, M933260, M936500, and M937960. Z-0885-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFR-70 - lot: M928700. Z-0886-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFS-6 - lots: M834100, M903280, M912650, M914740, M927830 and M928340. Z-0887-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #BFS-6CTT - lots: M912560, M931380 and M932530. Z-0888-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #TRAY 452 - lots: M912380, M916450, M919100, M924370 and M933050. Z-0889-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) Catalog #TRAY 453 - lot: M912390 REASON: Longitudinal slits MANUFACTURER/RECALLING FIRM: Medical Components, Harleysville, PA RECALLED BY: Manufacturer, by letter via fax on 6/1/00 and a follow up letter via UPS on 6/13/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and International QUANTITY: 22876 catheters _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0890-1 to Z-0892-1 Silicone catheters: Tesio is a long-term hemodialysis catheter. Schon Duo-Flow is a long-term hemodialysis catheter. Hemo-Cath is a dual lumen catheter. CODE: All lots REASON: Resent instructions for silicone catheters - not to use iodine MANUFACTURER/RECALLING FIRM: MEDICAL COMPONENTS, INC., Harleysville, PA RECALLED BY: Manufacturer, by letter dated 3/17/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide, Austria and Guam QUANTITY: Unknown _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1 REASON: Incorrect low results for a number of patient samples MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC., Newark, DE RECALLED BY: Manufacturer, by letter on 4/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & Government & Military. QUANTITY: 1696 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0914-1, Pride Jazzy Scooter. CODE: model number 1100; Z-0915-1, Pride Jazzy Scooter. CODE: model number 1104; Z-0916-1, Pride Jazzy Scooter, CODE: model number 1120; Z-0917-1, Pride Jazzy Scooter. CODE: model number 1170; Z-0918-1, Pride Jazzy Scooter, CODE: model number PHC1. REASON: Tire exploded MANUFACTURER/RECALLING FIRM: PRIDE MOBILITY PRODUCTS CORP., Exeter, PA RECALLED BY: The recalling firm sent a safety alert notification to all dealers and distributors on 12/8/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, England, Brazil, China, Belgium, Italy, Murcia, and Australia QUANTITY: 61510 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0907-1, Dimension RxL integrated chemistry system. Prostate Specific Antigen (PSA) Flex Reagent Cartridge, CODE: catalog number RF450. Lots: JS1284 exp. 10/11/01, IP1265 exp. 9/22/01, IR1265 exp. 9/22/01, HN1240 8/28/01, UA1207 exp. 7/26/01, UB1194 exp. 7/13/01, TC1174 exp. 6/23/01, FN1156 exp. 6/5/01, SA1125 exp. 5/5/01, DP1102 exp. 4/12/01, PC1087 exp. 3/28/01, CP1068 exp. 3/9/01, BM1045 exp. 2/14/01, AR1010 exp. 1/10/01, LS0344 exp. 12/9/00, and KM0327 exp. 11/22/00 REASON: False positive results - increased number MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: DADE BEHRING, INC., Glasgow, DE, by letter to all accounts. FIRM INITIATED RECALL: Complete DISTRIBUTION: The product was shipped nationwide & International to hospitals and medical facilities. QUANTITY: 10,327 cartons _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-927-1, Stryker Endoscopy brand 5.5mm 6 Flute Barrel Bur , Model Number(s): (Hooded) 275-951-000) Z-928-1, Stryker Endoscopy brand 5.5mm 6 Flute Barrel Bur , Model Number(s): (Unhooded) 275-951-200 REASON: The bur tip has a potential to separate from the bur shaft during surgery. MANUFACTURER/RECALLING FIRM: STRYKER ENDOSCOPY, Santa Clara, CA RECALLED BY: Manufacturer, via letters on 8/30/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1175 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-934-1 to Z-937-1 Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs. All products contain a label that states "SSIS Inc. Date ** Lot # ** Hos Part # ** Part Description: Sisters, OR ** Product has been EO Gas sterilized. ***". Code: 3527 REASON: STERILITY MAY BE COMPROMISED MANUFACTURER/RECALLING FIRM: Surgical Instrument Service & Savings, Inc., Sisters, OR RECALLED BY: Manufacturer, by telephone on 5/19/01 and a letter dated 5/29/01 was faxed and mailed via certified receipt. FIRM INITIATED RECALL: Complete DISTRIBUTION: OR QUANTITY: 12 pkgs saw blades; 7 high speed burrs, 12 twist drill bits, 7 burrsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0714-1, IntraCoil Self-Expanding Peripheral Endoprosthesis, Model VT640135, Code: Lot Numbers MF1826, MF1827 and MF1999 REASON: Mislabeled as to french size of the delivery catheter. MANUFACTURER/RECALLING FIRM: INTRATHERAPEUTICS, INC., St. Paul, MN RECALLED BY: Manufacturer, by a "RECALL" letter dated February 26, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 38 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0716-1, Innova Pelvic Floor Stimulation System and the touch-proof output jack adapter for the Innova Pelvic Floor Stimulation System. CODE: All Innova units with the old adapter are affected. The Innova was cleared for market 1/20/95. Innova units were first sold with an adapter on 5/7/00. An old-style (defective) adapter was provided for all Innova units which were originally shipped without an adapter prior to 5/7/00. No Innovas were sold with the old adapter after 9/6/00. The units which have been shipped with the new adapter are not affected. The new adapter can be identified by the word Innova which is printed on it. The old "defective" adapters are only "defective" to the extent that they do not function properly with the Innova device. They do however function appropriately with the firm's other devices which include TENS, powered muscle stimulators, and iontophoresis devices. REASON: Insufficient electrical contacts in adapter MANUFACTURER: EMPI, INC., Clear Lake, SD RECALLED BY: EMPI, INC., ST. PAUL, MN, by letter dated 1/17/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 191 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0732-1, FlexiLab Laboratory Information System version 5.3, release date 2/11/2001. REASON: Wrong normal ranges reported when age is listed as unknown. MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice, PSN-01-L15 instructing users to use Roll and Scroll IQ or printed reports to communicate results to a contact person. Project GL-IQ-3172 was created to address this problem. The project and its availability were communicated to users in PSN-01-L15 on May 11, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, OH, WI, PA, MD, FL, VA, WA and Washington DC QUANTITY: 89 sites between 3 recalls _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation. REASON: Software glitch MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice, PSN-01-L12 on April 19th, May 16th, and May 23rd of 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide & worldwide. QUANTITY: 89 sites between 3 recalls _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0727-1, SIMS Deltec, Inc. Gripper Port-A-Cath Needle, 0.9 mm (20 G) x 19 mm (3/4 in.), Re-order Number 21-2947-24. Labeled on some individual needle packages as: Z-0728-1, SIMS Deltec, Inc. Gripper Port-A-Cath Needle, 0.9 mm (20 G) x 25 mm (1 in.), Re-order Number 21-2948-24. Some of the product has SIMS Graseby Ltd. WD2 4LG UK as the distributor on the label instead of SIMS Deltec Inc. CODE: Lot Number 724X19 REASON: Misidentification of needle length on label. MANUFACTURER FIRM: INDUSTRIAS UNIDAS DE BAJA CALIFORNIA, MESA DE OTAY , MEXICO RECALLED BY: SIMS DELTEC, INC., ST. PAUL, MN, by "Product Recall Notification" dated 3/12/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide. France, Italy, and UK. QUANTITY: 2733 shelf boxes (each containing 12 needles) _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0743-1, Model 3625 Test Stimulator, CODE: S/N# NACO13714P through NACO13717P, NAC013738P through NAC013749P, NACO13752P through NACO13755P and NACO13759P through NACO13761P REASON: Reversed labels on amplitude and rate knobs. MANUFACTURER: MEDTRONIC, MILACA, MN RECALLED BY: MEDTRONIC, INC., MINNEAPOLIS, MN., by e-mail on or about 9/18/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 23 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0744-1, StatusFlow Pro CD34 Whole Blood Process Control for Flow Cytometry (CD34 positive cells), Code:Lot FC100-34 (StatusFlow Pro), Z-0745-1, StatusFlow Lo CD4-Low Whole Blood Process Control for Flow Cytometry (CD4 positive cells), Lot FC100-4L (StatusFlow Lo) REASON: Values tend to go out of assay range while product is still within expiration. MANUFACTURER/RECALLING FIRM: R & D SYSTEMS, INC., MINNEAPOLIS, MN RECALLED BY: Manufacturer, by letters dated 10/23/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide, Australia, France and Germany. QUANTITY: 79 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0906-1, Behring Coagulation System (BCS) software version 2.2 REASON: Leak of piston pump valve introduces air bubbles MANUFACTURER: DADE BEHRING MARBURG, Germany RECALLED BY: DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem and the name of the additional file to correct the problem. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY, IL, and MI QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Five Dimension RxL Flex Reagent Cartridges. The product is composed of: 1) Z-0908-1, Ferritin (FERR) 2) Z-0909-1, Human Chorionic Gonadotropic (HCG) 3) Z-0910-1, Mass Creatine Kinase MB Isoenzyme (MMB) 4) Z-0911-1, Myoglobin 5) Z-0912-1, Prostate Specific Antigen (PSA). FERR has 120 tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30 tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120 tests/carton; 30 tests/cartridge. PSA has 120 tests/carton; 30 tests/cartridge The product is sold by the cartridge or 4 cartridges per carton. CODE: FERR Lot FR9351 exp. 12/17/99, FERR Lot IR0063 exp. 3/3/99, HCG Lot HP0177 exp. 6/25/00, MMB Lot FP0100 exp. 4/9/00, MMB Lot HN0178 exp. 6/26/00, MMB WA0190 exp. 7/8/00, MYO Lot FP0074 exp. 3/14/00, MYO Lot FN0074 exp. 3/14/00, PSA Lot WA0253 exp. 9/9/00, and PSA Lot HP0239 exp. 8/26/00. REASON: Decline in stability following hydration. MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: DADE BEHRING, INC., Deerfield, IL, by letters via first class. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Germany, Australia, Canada, and Belgium. QUANTITY: 6447 units
END OF ENFORCEMENT REPORT FOR August 22, 2001. ####
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2001-AUG-23.