• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of September 24, 2014

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced W050910090401; W050910090745; W050910094326; W050911000731; W050911001126; W050911001129; W050911001238; W050911001241; W050911001809; W050911001857; W050911001888; W050911002317; W050911003036; W050911005301; W050911000208; W050911001105; W050910090448; W050911000301; W050911000303; W050911000307; W050911000311; W050911000316; W050911000324; W050911000325; W050911000714; W050911000721; W050911000777; W050911001243; W050911001254; W050911001850; W050911001897; W050911002009; W050911002333; W050911003043; W050911003291; W050911004508; W050911005088; W050910089939; W050910092725; W050910093657; W050911000327; W050911000628; W050911000646; W050911000725; W050911000769; W050911001109; W050911001119; W050911001237; W050911001849; W050911001851; W050911001869; W050911002335; W050911002658; W050911003245; W050911003262; W050911003996; W050911000203; W050911001236; W050911001839; W050911000343; W050911000629; W050911001087;  ...
More
Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W050911000138; W050911000478; W050911000716; W050911001093; W050911001807-part1; W050911001807-part2; W050911001830; W050911001996; W050911005037; W050911000179; W050911002043; W050911000155; W050911001021; W050911001879; W050911000133-part1; W050911005033-part2; W050911005043; W050911001732; W050911002002; W050911000132-part1; W050911000132-part2; W050911000133; W050911000134-part1;W050911000134;part2;W050911000170;W050911000178-part1; W050911000178-part2; W050911000190; W050911000193; W050911000224; W050911000735; W050911000742-part1; W050911000742-part2; W050911000745; W050911001020; W050911001250-part1; W050911001250-part2; W050911001289; W050911001734; W050911001803-part1; W050911001803-part2; W050911001821; W050911001866-part1; W050911001866-part2; W050911001867-part1; W050911001867-part2; W050911001872; W050911001993; W050911002005-part1; W050911002005-part2; W050911002016; W050911002024; W050911002027-part1;  ...
More
Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W050911002349; W050910094520; W050911002320; W050911002348; W050911002629; W050911005031; W050910089932; W050910094327; W050911001841; W050911002000; W050911002327; W050911000802; W050911003114; W050911004123; W050911002004 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Red Blood Cells (Apheresis) W050911000152; W050911005043; W050911005044; W050911005059; W050911001280; W050911002024; W050911000133; W050911000134; W050911000155; W050911000193; W050911000216; W050911000217; W050911000219; W050911000478; W050911000727; W050911000745; W050911000752; W050911001021; W050911001250; W050911001294; W050911001874; W050911001876; W050911001879; W050911002002; W050911002013; W050911002016; W050911001093; W050911001408; W050911002027; W050911000178; W050911001826; W050911001835; W050911001102; W050911000225; W050911000495; W050911000730; W050911001206; W050911001996; W050911000151; W050911000148; W050911000212; W050911001020; W050911001240; W050911001803 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma (Apheresis) W050911000138; W050911001021; W050911001206 W050911001732; W050911000224; W050911000132 W050911000219; W050911001830; W050911001993 W050911005056; W050911000152; W050911001855 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050910093657; W050911001841; W050911001142; W050911002335; W050911001236; W050910090448; W050911002346; W050910089932; W050910089939; W050910094327; W050911000203; W050911000628; W050911001135; W050911002327; W050911003036; W050911003040; W050911002331; W050910094326; W050910094520; W050911002317; W050911001119; W050911001243 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050911000478; W050911001280; W050911001993; W050911000169; W050911000727; W050911000151; W050911000152; W050911000217; W050911000727; W050911001240; W050911001855; W050911000193; W050911000224; W050911002002; W050911002013; W050911000216; W050911000212; W050911000752; W050911002013 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Biologics Red Blood Cells Irradiated W050911001092; W05091001113 Class II Blood products, incorrectly tested for cytomegalovirus (CMV), were distributed. HCSC-Blood Center
Veterinary Goldenfeast Australian Blend packaged in 32 lb foil Bulk Bags, 13 lb. foil mini bulk bags, 64 oz super size plastic jars, and 25 oz barrier film bags. Goldenfeast Australian Blend Bulk Bag, UPC741919167629, 32 lb. best if  ...
More
Class I Goldenfeast Inc. is recalling several bird seed blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Bean Supreme in 32 lbs.Foil Bulk Bag, 10 lb. Foil Mini Bulk Bags, 64 oz. Super Size Plastic Jars, and 23 oz. Barrier Film Bag. Bean Supreme Bulk Bag, UPC 741919167759, 32 lb., best if used by July 31,  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Caribbean Bounty Foil 32 lb. Bulk Bag Foil, 11 lb. Mini Bulk 64 oz. Super Size Plastic Jar, 25 oz. Barrier Film Bag. Caribbean Bounty Bulk Bag, UPC 741919167728, 32 lb., best if used by July 31, 2013  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Gardenflora Foil 12 lb. Bulk Bag, Foil 4 lb. Mini Bulk Foil Bag, Super Size 23 oz Plastic Jar, and Barrier Film 9 oz. Bag. Goldenfeast Gardenflora Bulk Bag UPC 741919167681, 12 lb., best if used by July 31, 2013  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Petite Hookbill Bulk Foil 32 lb. Bag, Foil Mini Bulk Bag 12 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag. Goldenfeast Petite Hookbill Bulk Bag UPC 741919167605, 32 lb., best  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Schmitts Original Bulk Foil 32 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 64 oz. Plastic Jar, and Barrier Film 25 oz. Bag. Goldenfeast Schmitts Original Bulk Bag UPC 741919167865, 32 lb., best if  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Basics Plus Finch Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size 80 oz. Plastic Jar, Barrier Film 32 oz. Bag. Goldenfeast Basics Plus Finch Bulk Bag, UPC 741919167926, 40 lb.,  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary Goldenfeast Basics Plus Parakeet Bulk Foil 40 lb. Bag, Mini Bulk Foil Bag 13 lb., Super Size Plastic Jar 72 oz, and Barrier Film 32 oz. Bag. Goldenfeast Basics Plus Parakeet Bulk Bag UPC 741919167933, 40 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Mini Bulk Bag UPC 741919165939, 13 lb., best if used by August 31, 2013 through February 28, 2014 Goldenfeast Basics Plus Parakeet Super Size Jar UPC 741919163935,  ...
More
Class I Goldenfeast Inc. is recalling several bird food blends due to possible contamination with Salmonella from parsley flake ingredients supplied by Specialty Commodities, Inc. Goldenfeast
Veterinary 34739-2, HOMESTEAD®, FASTGROW AM.0125 NAP/NAB, MEDICATED Complete Chicken Starter/Grower/Finisher/Broiler Feed, Complete Turkey Grower/Finisher, Aid in prevention of coccidiosis. ACTIVE DRUG INGREDIENT AMPROLIUM 0.0125 % GUARANTEED ANALYSIS ... CALCIUM, min 0.8 % CALCIUM, max 1.3 % PHOSPHORUS, min 0.65 % ... Net Weight 50 lb (22.68 kg) or bulk invoice Item 34739-2, Lot B00578594, B00582621, B00584526 Class I Hubbard Feeds has initiated a voluntary recall of three additional lots of Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED because of elevated calcium levels that may be harmful to chickens and turkeys. This voluntary recall is the result of identification of additional lot numbers through assays by the FDA related to a voluntary recall of the same product on July 2, 2013. Although no adverse events or complaints have been reported to date for the three additional lots, chickens and turkeys exposed to these lots may exhibit decreased feed intake, decreased growth rate or death Hubbard Feeds, Inc
Food Price Chopper Orange Juice; 100% Pure ORANGE JUICE FROM CONCENTRATE; DISTRIBUTED BY THE PRICE CHOPPER, INC., SCHENECTADY, NY 12306; in one gallon plastic containers UPC 0-41735-17135-1 Sell by 3/23/14 Class I undeclared dairy in orange juice Dean Foods, Inc.
Food Lehigh Valley Dairy Farms Orange Juice from concentrate HALF PINT (236 mL); DISTRIBUTED BY TUSCAN/LEHIGH DAIRIES, INC., A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in paper cartons UPC 0-70472-43022-3 Sell by 3/23/14 Class I undeclared dairy in orange juice Dean Foods, Inc.
Food Lehigh Valley Dairy Farms Orange Juice FROM CONCENTRATE; DISTRIBUTED BY LEHIGH VALLEY DAIRY FARMS, A DEAN FOODS COMPANY DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers UPC 0-70472-44014-7 Sell by 3/23/14 Class I undeclared dairy in orange juice Dean Foods, Inc.
Food Swiss PREMIUM 100% Pure Orange Juice FROM CONCENTRATE; DIST BY: SWISS PREMIUM DAIRY; A DEAN FOODS COMPANY; DALLAS, TEXAS 75204 in both half gallon and one gallon plastic containers UPC 0-76545-00132-1 Sell by 3/23/14 Class I undeclared dairy in orange juice Dean Foods, Inc.
Drugs AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. 2006-000926 Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA., 2006-3627878 Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012 Lot# 130310GL Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012 Lot# 130520PL Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012 Lot# 13051012 Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: xzone, Orlando, FL 32789 Lot# 13071012 Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789 lot# 131110GL Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 Lot# 10081359 Class I Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling MOJO RISEN, because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. Nova Products, Inc.
Drugs NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 Lot # 00083844 Exp. 07/13 Class II Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. Unique Pharmaceutical, Ltd
Food Avocados approximately 14-30 oz each in packed 20 units in cardboard boxes with black lettering labeled in part: in part: "USDA/FL 2/196 LOT# 2610". Code # 2610 Class I Found positive for Salmonella. Brooks Tropicals, LLC
Devices Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs). Model Number: KHA1000-US; Serial Numbers: P0111930  ...
More
Class II ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage. ARJOHUNTLEIGH POLSKA SP. ZO.O.
Drugs COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96 Lot 00201125, Exp. 09/14; 00201126 Exp.11/14; 00201127, Exp.12/14; 00201228 Exp.06/15; 00201229 Exp. 07/15; 00201230, Exp. 09/15 Class I Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials Bristol-Meyers Squibb
Drugs THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA. None Available. All lots distributed prior to 02/06/2014 are being recalled. Class I Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Nature's Universe
Devices BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Lot::3319877 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Lot: 3343067 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry. Lot(s): 3305588 and 4006903 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination. Lot: 4007096 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies. Lot: 4007362 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Lot: B011403 Class II Products were held at improper storage temperature Fresenius Medical Care Holdings, Inc.
Devices C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014 H272181 H272354 H272820 H140018 H140202 H140727 H140793 H140859 H140926 H140987 H271293 H271759 H272015 H272187 H272359 H272822 H140025 H140203 H140728  ...
More
Class II Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. Varian Medical Systems, Inc.
Drugs 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14 Class I Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Baxter Healthcare Corp.
Drugs 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043. Lot #: P308650, Exp 10/14 Class I Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Baxter Healthcare Corp.
Drugs Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. Lot #: P309476, Exp 10/14 Class I Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Baxter Healthcare Corp.
Drugs Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01 Lot #142588, Exp 01/2016 Class I Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544 American Health Packaging
Drugs Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01 Lot #142544, Exp 02/2016 Class I Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544. American Health Packaging
Biologics AbSorber XM-ONE Transplantation Cross Match, ABX100-03 Lot 14E03002 Class III AbSorber XM-ONE Transplantation Cross Match (ABX100-03), containing a certain lot of BD Vacutainer Cell Preparation Tubes (CPT) which has the potential for poor separation resulting in a reduced number of recovered mononuclear cells, was distributed. Olerup SSP AB
Food JSF Ground Tuna - IQF - Origin: Indonesia - 2/11LB, frozen All lots Class II Product associated with scombroid illness. Japanese Specialty Food Distributors Ltd, Co.
Devices ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591-5097 USA --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. Lots 3HD044 (exp. 11/01/2015), and 3LD068 (exp. 01/01/2016) Class II ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD --- ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. Siemens Healthcare Diagnostics
Devices Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521 Class II Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Genesis BPS, LLC.
Devices Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion Cat #405-560BD Lot # 3650-23508; 3650-24116; 3650-24332; 3650-24399; 3650-24487; 3650-24519; 3650-23478; 3650-23971 Cat # 405-60MJ Lot #3630-23509; 3630-23972; 3630-24181; 3630-24333; 3630-24397; 3630-24488; 3630-24152 Class II Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Genesis BPS, LLC.
Devices Pedi-Pak Pedi-Syringe Filter 35 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion. Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301 Class II Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. Genesis BPS, LLC.
Devices VERO (TM) Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919 Class II Software Anomaly: Due to certain software bug, if a user changes the calendar setting from "workday" to "holiday" or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become "treated (completed)" status on the exact day when such change is made, to "untreated" status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as "untreated" treatment. MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Food Raw Milk Mild Cheddar Cheese, in 8 oz, (UPC 79004-10002) and 5 lb. (no UPC) size packages. Lot # 103-114 Class I Mt. Sterling Coop Creamery is recalling one lot of Raw Goat Milk Cheddar Style Cheese in 5 lb and 8 oz sizes because it may be contaminated with Shiga toxin producing Escherichia coli (STEC) O111:H8 bacteria. SW Wisconsin Dairy Goat Products Coop
Food Lean Cuisine Culinary Collection Chicken with Peanut Sauce. Packaged in 9 oz (255g) Plastic Tray in Fiberboard Carton 12 cartons per case by Nestle USA, INC, Solon, OH 44139 USA. UPC code 13800 10154, production code of 4165595911U and has a best before date of JULY 2015 Class I Nestlé Prepared Foods Company Announces Allergy Alert and Voluntary Recall of LEAN CUISINE Culinary Collection Chicken with Peanut Sauce Recall Due to Package Mislabeling Nestle USA, Inc.
Food Green Vibrance- A Comprehensive Restorative Advanced Daily Superfood (Dietary Supplement) packaged as follows: A. 15-day, 181.5g, 6.4 oz. powder- Product Code GV15; B. 30-day, 363g, 12.8 oz. powder; Product Code GV 30; C.60-day, 726g, 25.61 oz. family size powder, -Product Code GV60; D. Bulk Supply Kilo Canister, 1 kg (35.27 oz.) powder,-Product Code GVKG Lot Numbers: A. 1401084 B. 1401083, 1401092, 1401094 C. 1401081, 1401082, 1401085, 1401086, 1401087, 1401088,1401089 D. 1401079, 1401080, 1401081 Class I A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria. Vibrant Health
Food Green Vibrance 15 single serve pkts, 181.5g, 6.4oz. Product Code: GVSD Lot Number: 1401076 Class I A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria. Vibrant Health
Food Green Vibrance, 240 Vegicaps/bottle Product Code: GVC Lot Number:1401078 Class I A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria. Vibrant Health
Food Rainbow Vibrance Hi ORAC Superfood, 177g, 6.24 oz. Product Code: RV Lot Number:1311139 Class I A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria. Vibrant Health
Devices Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric. "Product Model No: SUAOI "SeriaJ No: SUI4B01391-SU14B02117. SU14C00556-SU14C01280 Class II EMG Technology Co., Ltd. Is voluntarily recalling Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister) with serial number ranges: SU14B01391-SU14B02117 and SU14C00556-SU14C01280 which contain suction canister lids that may have occluded ports. EMG Technology Co., Ltd.
Biologics Source Plasma 3940135686; 3940135217; 3940134813; 3940133734; 3940133338; 3940132544; 3940132206; Class II Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W069109116335 Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. Mississippi Blood Services Inc.
Biologics Source Plasma BY0444467 Class III Blood product, in which donor testing was not performed or incomplete, was distributed. DCI Biologicals, LLC
Biologics Source Plasma WN0389104 Class III Blood product, collected from a donor with no documentation of an arm inspection or general appearance, was distributed. DCI Biologicals Wilmington, Inc.
Biologics Source Plasma JV0122563; JV0122875; JV0123645; JV0123925; JV0124728; JV0125150; JV0126722; JV0127025; JV0127788; JV0128178; JV0128948; JV0129346; JV0130015; JV0130382; JV0131205; JV0131560; JV0132415; JV0132765; JV0133787; JV0134377; JV0134974; JV0136689; JV0137281; JV0139215; JV0139589; JV0141293; JV0141745; JV0142416; JV0142821; JV0167217; JV0143791; JV0144309; JV0145020; JV0146031; JV0146344; JV0146980; JV0147407; JV0148164; JV0148546; JV0150534; JV0150966; JV0151670; JV0152222; JV0152777; JV0153679; JV0154019; JV0155316; JV0155692; JV0157060; JV0157676;  ...
More
Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. DCI Biologicals Orlando LLC
Biologics Platelets Pheresis Leukocytes Reduced W051514058460 Class II Platelets, with insufficient plasma volume to support the platelet yield, were distributed. Innovative Blood Resources
Biologics Red Blood Cells Leukocytes Reduced W165713021650Q Class II Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. Our Lady Of The Lake Hospital Inc
Biologics Blood Grouping Reagent Combination Kit 10011303759; 10241303753; 10241303764; 12021303755; 12021303761; 12021303766; 01201403756; 02121403751; Class III MTS A/B/D Monoclonal and Reverse Grouping Cards, with the potential for false positive reactions with some lots, were distributed. Micro Typing Systems, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W041013191843F; Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. United Blood Services
Biologics Red Blood Cells (Apheresis) Leukoreduced W072114001043; Class II Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed. Southern California Permanente Medical Group
Biologics Red Blood Cells Leukocytes Reduced W072114003240; Class II Blood product, labeled "leukoreduced", but which had not undergone leukoreduction, was distributed. Southern California Permanente Medical Group
Devices JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis. Model Number(s): JRPD-SFW-0001 Class III BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed. Biofire Defense
Devices SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin. PN 8000809705; Serial numbers 248-1298 Class II The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process). JK Products & Services, Inc
Devices The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. 91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157 Class II During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software update to Beta 3 to correct this issue. Philips Medical Systems (Cleveland) Inc
Devices Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. Part number 91003: All Lots Class II Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. Volcano Corporation
Devices The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243. System Code #, 728243, 728244, Serial #: 7022, 7118, 7151, 7298, 7343, 7360, 7361, 7362, 7363, 7364, 7365, 7366, 7367, 7368, 7369, 7370, 7371, 7372, 7373, 7374, 7375, 7376, 7377, 7378, 7379, 7380, 7381, 7382, 7383, 7384, 7385, 7386, 7387, 7388, 7389, 7390, 7391, 7392, 7393, 7394, 7395, 7396, 7397, 7398,  ...
More
Class II Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode. Philips Medical Systems (Cleveland) Inc
Devices B.Braun "Accuflo 100ML/H 100ML" Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. Lot Number: 4A1125F111 Class II B. Braun Medical Inc. (USA) became aware that one (1) lot of the CT-1000-100 "Accufix 100ML/H 100ML" product was recalled by their German manufacturing site due to customer complaints that product was distributed to U.S. customers which contains incorrect product labeling. Specifically, the primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are CT-1000-100. B. Braun Medical, Inc.
Devices Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.). Model # Serial # APS98674 1161998674140123 APS98674 1169000522  ...
More
Class II GF Health Products, Inc / Basic American Medical Products is conducting a recall on various models of Zenith Slide W-I-D-E Long Term Care Beds. The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended. GF Health Products, Inc./d.b.a.Basic American Metal Products
Devices BD BBLTM Vancomycin Screen Agar Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. Product number - 4080291 4042217 4048040 4052349 4058242 4073274 4127728 Class II BD has confirmed reports that the referenced lots of Vancomycin Screen Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Vancomycin Screen Agar that is allowing susceptible enterococci to grow gives the appearance of a falsely resistant culture. With the majority of laboratories performing appropriate QC testing, it is likely that QC will identify the problem and the results would not be used for patient reports. However, on the chance that a laboratory is not performing QC, falsely resistant enterococci would still go on to have further AST workup and the error would be identified. There could be a delay in the identification of false-resistance. Becton Dickinson & Co.
Devices AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. model # 10094200, see distribution list for individual device serial numbers Class II It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically disable the affected button(s) with the start-up of the system. Pressing button on the control panel may lead to unintended system movement. The remote control panel is not affected by any malfunction of the tableside control panel and can reliably be used at any time. In case of a malfunction of the tableside control panel, users are recommended to switch to solely using the remote control panel(s). Siemens Medical Solutions USA, Inc
Devices Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. 510(k) #K111822, Lot #112366, Part # REF 00311US Class III Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. Diagnostica Stago, Inc.
Devices ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. All Serial Numbers Class II The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide. Siemens Healthcare Diagnostics
Devices ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. All Serial Numbers Class II The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide. Siemens Healthcare Diagnostics
Drugs Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3. Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016. Class III Failed Content Uniformity Specifications. Taro Pharmaceuticals U.S.A., Inc.
Food Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115. Lot 206401 Best By date of 6/15. Class I Swanson Certified Organic Carob Powder, item number SWF115 is being recalled due to a potential risk of Salmonella contamination from a raw ingredient used in this product. Swanson Health Products, Inc
Devices Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Lot codes: 3WD02, 3WD03, 3WD04, and 3WD05 Class II Not approved labeling claims (antimicrobial and autolytic debridement) Amerx Health Care Corp.
Devices Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management. Lot codes: 05368, 05345, 09282, 10295, 12201, 12303, 12303, 12328, 13100, 13115, and 13180. Class II Not approved labeling claims (antimicrobial and autolytic debridement) Amerx Health Care Corp.
Devices Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management. Lot codes: JCA0086 through JCA0106. Class II Not approved labeling claims (antimicrobial and autolytic debridement) Amerx Health Care Corp.
Devices Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management. Lot codes: 2WD07. Class II Not approved labeling claims (antimicrobial and autolytic debridement) Amerx Health Care Corp.
Devices ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Version #s: 1.0.0 Date Released 6/17/2004, 1.0.1 Date Released 8/18/2004, 1.1.1 Date Released 9/9/2004, 1.2.0 Date Released 10/11/2004, 1.3.0 Date Released 11/1/2004, 1.3.1 Date Released 1/20/2005, 1.3.2 Date Released 2/18/2005, 1.4.0 Date Released 3/30/2005, 1.4.1 Date Released 8/31/2005, 1.4.2 Date Released 9/12/2005, 1.4.2 Date Released 10/5/2005, 1.4.3 Date Released 2/8/2006,  ...
More
Class II Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances. Dawning Technologies, Inc
Veterinary PEDIGREE Adult Complete Nutrition Dry Dog Food sold under the Pedigree brand in 15 and 55 lbs. bags. 1) 15 lbs. bags; UPC: 23100 10944; 2) 55 lbs. bags; UPC: 23100 10731 Class II Mars Petcare US is recalling specific 15 and 55 pound bags of PEDIGREE Adult Complete Nutrition Dry Dog Food because they may contain metal fragments. Mars Petcare US
Food Thien Minh Cashew Kernels, Net Wt. 50 lb. Product of Vietnam Lot Number: 105327-1-01 Class I The Cashew Pieces have the potential to be contaminated with Salmonella. Specialty Commodities, Inc.
Food Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups. UPC 3663202602 Exp code Oct 04 2014 Class III The recalled product includes an ingredient (condensed skim milk) that the supplier Dairy Farmers of America has advised may have been produced from raw milk that has tested positive for the presence of sulfamethazine antibiotic. The Dannon Company, Inc - Discovery & Innovation Center
Devices Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin. Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690. Class II Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. Beckman Coulter Inc.
Devices TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. All units manufactured between June 2011 and May 2014: Serial Numbers 28583, 28597, 28604, 28607, 28629, 30138, 30334, 028380, U001050, U001083, U001544, U002020, U002326, U002386, U002403, U002411, U002489, U002502, U002505, U002509, U002510, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006132, U006234, U006235,  ...
More
Class II Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner). Motion Concepts
Devices Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required. Models BR-144, BRS-144 and BRC-144 Class II Marketing without marketing clearance or approval. Advanced Photonic Systems, LLC
Devices Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes. Model 150 Class II Marketing without marketing clearance or approval. Advanced Photonic Systems, LLC
Devices Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the product provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes. Models ULT-1, TDR-1, and TDR-2 Class II Marketing without marketing clearance or approval. Advanced Photonic Systems, LLC
Devices 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Model number H51; Serial numbers: H51B429 H514517 H511720 H514463 H511002 H513925 H514115 H510855 H515068 H514544 H512492 H515879 H515060 H513064 H514438 H514022 H512957 H514553 H515102 H515991 H515511 H51B421 H515106 H514189 H513551 H513009 H515033 H51B568 H515804 H51B611 H515004 H513477 H513133 H513562 H510966 H515691 H513894 H515363 H513801 H51B362 H518326 H518191 H514863 H513889 H514050  ...
More
Class II Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. Varian Medical Systems, Inc.
Food Dole Spinach: Thoroughly Washed, Preservative Free Net Wt. 8 oz. bag; Perishable, keep refrigerated. UPC 071430009765 SKU 320 Dole Fresh Vegetables Monterey, CA 93940 Bag Code Expiration Date B2311020 9/4/2014 B23110211 9/4/2014 B2311022 9/4/2014 B2311023 9/4/2014 B2311024 9/4/2014 B2311025 9/4/2014 Class I Green Walnuts from a tree dropped into spinach as it was being tractored away from the harvested field. Walnuts were discovered on the Dole spinach processing line Dole Fresh Vegetables Inc
Food Dole Baby Spinach: Thoroughly Washed, Preservative Free, All natural Net W.t6 oz. bag; SKU 323 Perishable, keep refrigerated. UPC 071430009642; Dole Fresh Vegetables Monterey, CA 93940 Bag Code Expiration Date B2311020 9/4/2014 B23110211 9/4/2014 B2311022 9/4/2014 B2311023 9/4/2014 B2311024 9/4/2014 B2311025 9/4/2014. Class I Green Walnuts from a tree dropped into spinach as it was being tractored away from the harvested field. Walnuts were discovered on the Dole spinach processing line Dole Fresh Vegetables Inc
Devices Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474 Class II Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary. Siemens Healthcare Diagnostics, Inc.
Food Apple Cider Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Cocoa Zin- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Cranberry Royale- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Creme Fraiche- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Cucumber Granita- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Dark Cocoa Peppermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Forest Berry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Heirloom Melon Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Lapsang Souchong with Armagnac Prumes- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Pineapple Yogurt- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Pumpkin 5 spice- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Belgian Milk Chocolate- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Savannah Buttermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Spiced Pecan Praline- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Star Anise with Candied Fennel- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Strawberry Rose Petal- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Strawberry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Sweet Basil with Honey- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Sweet Corn with Blackberry- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Food Winter Squash with Pecan Pralines- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. No codes: product distributed/purchased 1/1/2006-6/27/2008 Class II Frozen desserts do not include ingredients on the labeling. Jenis Splendid Ice Creams LLC
Drugs Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA All lots Class II Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling. Solace International Inc
Drugs Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA All lots Class II Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling. Solace International Inc
Devices Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies. LW0037 REVH0625 LW0037 REVJ0285 LW0037 REVK0279 LW0037 REWD1346 LW0037 REWE1663 LW0037 REWH0210 LW0037 REWJ1662 LW0037 REWL1233 LW0037 REXC0151 LW0037 REXC1597 LW0037 REXJ0487 LW0037 REXK2010 LW0037 REYB1500 LW0037 REYC1644 LW0037 REYE2175 LW0037 REYG0975 LW0057 REVH1110 LW0057 REXF0126 LW0057 REVJ0284 LW0057 REXF2249 LW0057 REVJ1392 LW0057 REXG2346 LW0057 REVK0821 LW0057 REXH0014 LW0057 REWA0386 LW0057 REXH1180 LW0057 REWB0291 LW0057 REXJ0280 LW0057 REWB1686 LW0057 REXJ0560 LW0057 REWC0831 LW0057 REXJ2036 LW0057 REWD1328 LW0057 REXK0397 LW0057 REWE1476 LW0057 REXK0676 LW0057 REWF1566 LW0057 REXL0506 LW0057  ...
More
Class II Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier. Bard Peripheral Vascular Inc
Devices ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture. Lot Number: 2314 Class II Sterility of device is not assured Bio-Detek, Inc.
Devices ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture. Lot Number: 2314 Class II Sterility of device is not assured Bio-Detek, Inc.
Devices ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Lot Number: 2314 Class II Sterility of device is not assured Bio-Detek, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W0352141765603 (2 units) Class II Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed. Carter BloodCare
Biologics Platelets Pheresis Leukocytes Reduced W203214808832 Class II Platelet, with an unacceptable pH, was distributed. American National Red Cross (The)
Drugs Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9 Lot # KK6086, exp 03/2015, UPC 360505375998. Class III Failed Impurity/Degradation Specification; high out of specification for CAD II degradant Apotex Corp.
Devices Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use. Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot  ...
More
Class II Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label. Teleflex Medical
Biologics Red Blood Cells Leukocytes Reduced W051714625890 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Rhode Island Blood Center
Food Avocados, PLU#4770, size 32, 32 pcs/case. Packed in boxes with green, yellow, and red print with a black and white label. Lot No. 03053161 Class I Calavo Growers is recalling Avocados because they may be contaminated with Salmonella. Calavo Growers, Inc. (Corporate)
Biologics Cryoprecipitated AHF W050910047496 W050910045366 W050910055975 W050910052566 W050910055973 W050910040784 W050910048003 W050910054073 W050910054082 W050910062762 W050910062770 W050910042074 W050910042065 W050910055764 W050910043591 W050910043590 W050910042007 W050910042025 W050910055982 W050910061069 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Biologics Plasma cryoprecipitate reduced W050910055975 W050910048003 W050910052566 W050910054073 W050910054082 W050910055764 W050910055973 W050910061069 W050910047496 W050910062770 W050910062762 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050910091018 W050911000033 W050911000239 W050911000037 W050910088077 W050910088078 W050910086210 W050911000043 W050911002359 W050910086213 W050910086224 W050910090596 W050911000038 W050910086345 W050910088085 W050910090600 W050910084341 W050910084357 W050910086339 W050910086340 W050910088087 W050910089916 W050911000819 W050911000821 W050910086227 W050910084314 W050910084317 W050910086354 W050910090594 W050910090905 W050910090922 W050911000034 W050910088090 W050910089909 W050910089920 W050910084641 W050911004548 W050910086349 W050910088079 W050911002355 W050911004537 W050910090908 W050910090597 W050911000826 W050910088093 W050910088091 W050910088382 W050910088611 W050911000828 W050911000983 W050910088601 W050910086207 W050910088099 W050910086208 W050910086337 W050910088088 W050911000242 W050910091006 W050910089914 W050910084636 W050911000039 W050911000249 W050911000990 W050911004994 W050911004992 W050911004993 W050911000246 W050911002350 W050910088609 W050910090912 W050911004538 W050911000253 W050910088080 W050911004792 W050911000985 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Biologics Fresh frozen plasma W050910055793 W050910056206 W050910077070 W050910077072 W050910077090 W050910077091 W050910078541 W050910082479 W050910082517 W050910082527 W050910082530 W050910082535 W050910082536 W050910084357 W050910052277 W050910078501 W050910078524 W050910055767 W050910056205 W050910061015 W050910052160 W050910052162 W050910063287 W050910077309 W050910070323 W050910070341 W050910055768 W050910055783 W050910047478 W050910043599 W050910042100 W050910046943 W050910064629 W050910070525 W050910070528 W050910081033 W050910052255 W050910054076 W050910082800 W050910052581 W050910068698 W050910071446 W050910055918 W050910055921 W050910055936 W050910059364 W050910059366 W050910061024 W050910063294 W050910068779 W050910070348 W050910070355 W050910071434 W050910071440 W050910077096 W050910081004 W050911000034 W050910046907 W050910046970 W050910058994 W050910046909 W050910055763 W050910055923 W050910063290 W050910063293 W050910070531 W050910084436 W050910088085 W050910058895 W050910063147 W050910077078 W050910067789 W050910081008 W050910086214 W050910052576 W050910052575 W050910082797 W050910067771 W050910058888 W050910071428 W050910084431 W050910090908 W050910042071 W050910050599 W050910051493 W050910067769 W050910067773 W050910067788 W050910070779 W050910071942 W050910084341 W050910084345 W050910084433 W050910086339 W050910050585 W050910058877 W050910086223 W050910051428 W050910051437 W050910081035 W050910047495 W050910055758 W050910086210 W050910086220 W050910070439 W050910055933 W050910059311 W050910055932 W050910045355 W050910077084 W050910078503 W050910046921 W050910046953 W050910040778 W050910084321 W050910071409 W050910081029 W050910082515 W050910082532 W050910086226 W050910086354 W050910084443 W050911000253 W050911004982 W050911004992 W050911000828 W050910062765 W050910070778 W050910046784 W050910068772 W050910071947 W050911004538 W050910078021 W050911004548 W050910084439 W050910090600 W050910084440 W050910071932 W050910064627 W050910084314 W050910054062 W050910067790 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Biologics Red blood cells leukocytes reduced W050910084327 W050910089911 W050910086212 W050910088385 W050910086299 W050910086222 W050910084311 W050911000031 W050911000962 W050910088095 W050910088612 W050910086226 W050911002351 W050910084319 W050910084345 W050910091016 W050910086223 W050911000981 W050910089912 W050910086216 W050911000971 W050910084309 W050910084321 W050910084331 W050910086214 W050910090902 W050911000831 W050911000848 W050911000958 W050911000967 W050911004547 W050911000846 W050911002352 W050911000969 W050911004549 W050911000960 W050911002357 W050911000844 W050911004776 W050911000965 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Biologics Red blood cells leukocytes reduced irradiated W050911000042 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. HCSC-Blood Center
Drugs Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02 LOT 37-268-DK; Exp: 1JAN2016 Class II Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. Hospira Inc.
Show all Code Info
-
-