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

Enforcement Report - Week of September 4, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced Irradiated FZ84753; FZ67148 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Tri-Counties Blood Bank dba UBS- Central Coast
Biologics Source Plasma 0240040461 0240040607 0240040965 0240041244 0240041520 0240041692 0240041975 0240042119 0240042387 0240042542 0240043129 0240043412 0240046534 0240047103 0240047349 0240051087 0240051325 0240051467 0240051896 0240052089 0240052589 0240052960 0240053136 0240053559 0240053689 0240054107 0240054272 0240054519 0240054707 0240057424 0240057614 0240057845 0240057951 0240058295 Class III Blood products, collected from a donor who were previously deferred, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells FM49257 Class II Blood products, collected from a donor in which donor suitability were not adequately determined, were distributed. San Diego Blood Bank
Biologics Blood and Blood Products for Reprocessing FM49257 Class III Blood products, collected from a donor in which donor suitability were not adequately determined, were distributed. San Diego Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GW76846, GW77802, GW77774, GW76276, GW76976, LF96430, GW75184 GW71105, LF41595, LF44579, GW70944 Class II Blood products, with discrepancies documented on the irradiator worksheet, were documented. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated T28221; T28223; LT13552; KH00896; GW77721; FZ63465 Class II Blood products, with discrepancies documented on the irradiator worksheet, were documented. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced GP53054 Class II Blood product, which was not quarantined after the donor provided information of a possible blood exposure, was distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 103326325(Part A) ;103326325(Part B) Class II Blood products, which were possibly contaminated with Propionibacterium species, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 103329106 Class III Blood product, prepared without the appropriate amount of RBC additive, was distributed. Blood Systems, Inc.
Veterinary Vitae Cockatiel with Sunflower, 2lbs and 4lbs 2lbs: #2840081 4lbs: #2840090 Class I Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella. Merit Bird Co Llc
Veterinary Vitae Small Hookbill, 4lbs. #2840225 Class I Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella. Merit Bird Co Llc
Veterinary Vitae Hookbill with Sunflower, 4lbs #2840252 Class I Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella. Merit Bird Co Llc
Veterinary Vitae Large Hookbill 4lbs #2840279 Class I Merit Bird Company is recalling Vitae brand bird food because it has the potential to be contaminated with Salmonella. Vitae brand bird food contains parsley that has been recalled by Specialty Commodities due to Salmonella. Merit Bird Co Llc
Devices Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 Model Number: V1000 Class II Respironics is recalling the Esprit Ventilator because the power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable. Respironics California Inc
Devices Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality. BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345. Class II Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position. Ventana Medical Systems Inc
Biologics Red Blood Cells W020407001257(Part A) Class II Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed. Department of the Navy
Biologics Red Blood Cells Leukocytes Reduced 2505947(Part B); 2505947(Part A) Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Central Kentucky Blood Center, Inc.
Biologics Source Plasma 4010385306, 4010380342, 4010378525, 4010377269, 4010375680, 4010372630, 4010371286, 4010369520, 4010366600, 4010366018, 4010363199, 4010362024, 4010359948, 4010358848, 4010356507, 4010355653, 4010353634, 4010352798, 4010350869, 4010350194, 4010348008, 4010347113, 4010342557, 4010340338, 4010339336, 4010337242, 4010336024, and 4010334118. Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. ZLB Bioplasma, Inc.
Biologics Source Plasma 6240116008, 6240114828, 6240114488, 6240113180, 6240112683, 6240112255, 6240111762, 6240111293, 6240104434, 6240103955, 6240103468, 6240102459, 6240102151, 6240101060, 6240100545, 6240100249, 6240096498, 6240096282, 6240095705, 6240095542, 6240094616, 6240094335, 6240171459, 6240170301, 6240169568, 6240168524, 6240167858, 6240159565, 6240157733, 6240242264, 6240235823, 6240235001, 6240233210, 6240232410, 6240230671, 6240229798, 6240227180, 6240226607, 6240224825, 6240224324, 6240222569, 6240221010, 6240219932, 6240218272, 6240217915, 6240215921, 6240215367, 6240212924, 6240211102, 6240210399,  ...
More
Class III Blood products, collected from a donor who was deferred for specific high risk behavior, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 3800034441, 3800032963, 3800031721, 3800031117, 3800061119, 3800044099, 3800043574, 3800043308, 3800042701, 3800042446, 3800040166, 3800036611, 3800036056, 3800035601, 3800033829, 3800031619, 3800031056, 3800029495, 3800029052, 3800027611, 3800020879, 3800019437, 3800019060, 3800016421, 3800043103, 3800043401, 3800044883, 3800061156, 3800062351, 3800062037, 3800061087, 3800059037, 3800057791, 3800057431, 3800053183, 3800052751, 3800050597, 3800050012, 3800049533, 3800048851, 3800048498, 3800047437, 3800046967, 3800046487, 3800046099, 3800045624, 3800045148, 3800044755, 3800044108, 3800043854,  ...
More
Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. Talecris Plasma Resources Inc
Biologics Red Blood Cells Leukocytes Reduced W037708008520 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 4010524355, 4010518464, 4010517947, 4010516062, 4010514826, 4010507392, 4010506029, 4010504818, 4010503337, 4010501851, 4010499271, 4010497910, 4010495665, 4010494055, 4010491689, 4010490120, 4010488628, 4010487504, 4010485973, 4010482183, 4010481281, 4010479330, 4010478451, 4010474047, 4010471633, 4010469507, 4010468806, 4010465637, 4010464407, 4010461473, 4010460645, 4010458117, 4010453450, 4010451579, 4010447611, 4010447306, 4010444375, 4010443536, 4010441073, 4010411298, 4010409700, 4010408327, 4010406301, 4010402687, 4010401931, 4010399283, 4010398658, 4010396016, and 4010395462. Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. CSL Plasma Inc
Biologics Source Plasma 4010349576;4010350620;4010347554;4010343601;4010342564;4010340320;4010338885;4010337382;4010335733;4010334286;4010331474;4010330072;4010328777;4010327410;4010325363;4010324357;4010306670;4010305812; 4010304113; 4010302270; 4010297706; 4010296811; 4010295138; 4010293950; 4010292781; 4010291645; 4010290249; 4010288987; 4010287618; 4010281923; 4010276581; 4010274380; 4010273818; 4010271959; and 4010271435. Class III Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed. CSL Plasma, Inc.
Drugs 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 Lot Number 05-201-JT, Expiration Date 1MAY2013 Class I Presence of Particulate Matter; product may contain fibrous material Hospira Inc.
Veterinary Brewtech Dried Brewers Yeast, manufactured by International Ingredient Corporation, P.O. Box 26377, St. Louis, MO 63026 sold in 50 lb. bags, 2000 lb. bulk totes, and 2205 lb. bulk totes. Lot codes: FN-14-Z1, FN-15-Z1, FN-16-Z1, FN-17-Z1, FN-21-Z1, FN-22-Z1, FN-23-Z1 Class I The product has the potential to be contaminated with salmonella. International Ingredient Corp
Veterinary Premium Edge Finicky Adult Cat Formula, 6 lb. bags &18 lb. bags, Premium Edge® Pet Foods P.O. Box 156 Meta, MO 65058. Production Codes: NGF0802, Best By: 15-Aug-2013, 16-Aug-2013 (6 lb. bags) and Production Codes: NGF0703, Best By: 10-Jul-2013(18 lb. bags). Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary Premium Edge Senior Cat Hairball Management Formula, 6 lb. and 18 lb. bags, Premium Edge® Pet Foods P.O. Box 156 Meta, MO 65058. Production Codes: NGS0101, Best By: 03-Jan-2014, 04-Jan-2014 and Production Codes: NGS0702, Best By: 10-Jul-2013. Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary Premium Edge Kitten Formula, 6 oz. samples, 6 lb. and 18 lb. bags, Premium Edge Pet Foods P.O. Box 156 Meta, MO 65058. Production Code: MKT0901; Best Before: 26-Sept-2013, 29-Sept-2013, 30-Sept-2013 and 02-Oct-2013 Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary Diamond Naturals Kitten Formula, 6 oz. samples and 6 lb. bags, Proudly made by Diamond Pet Foods, Meta, MO 65058 USA. Production Codes: MKT0901, Best By: 30-Sept-2013 Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary 4health All Life Stages Cat Formula, 5 lb. and 18 lb. bags, Distributed By: Tractor Supply Company, 200 Powell Place, Brentwood, TN 37027. Production Codes: NGF0802, Best By: 14-Aug-2013 and 18-Aug-2013. Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary Nutra Gold Indoor Kitten Formula, 3 Kilogram and l Kilogram Production Code: MKT0901, Best By: 26-Sep-2014 and 26-Mar-2014. Class I Product may contain low thiamine levels (vitamin B1). Schell & Kampeter, Inc.
Veterinary Bravo! Raw Food Diet Chicken Blend for Dogs and Cats, 2lb. tube, frozen Product Code: 21-102 Batch ID Code / Production Code Date 6_14_12 on white tag attached to the bottom of the plastic film tube. Expanded Recall: Best Used By 3_21_15. Class I Product contaminated with salmonella BRAVO! LLC
Veterinary Bravo! Raw Food Diet Chicken Balance For Dog and Cats, 5 lb bags, frozen Product Code: 21-405 Best Used By" dates of 3_6_15 and 3_12_15 imprinted on the side of the plastic casing. Class I Potential for Product to be contaminated with salmonella BRAVO! LLC
Veterinary Bravo!.Raw Food Diet Beef Blend Burgers For Dog and Cats, 5 lb bags, frozen Product Code: 51-508 Best Used By 3_21_15 and 3_22_15 imprinted on the back panel of the plastic bag. (Batch ID and Use by Dates are the same) Class I Potential for Product to be contaminated with salmonella BRAVO! LLC
Food Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs Lot #2243 Class II Recall is being conducted based on a finding of possible contamination by the supplier of the firms lemongrass. Custom Co-Pak, LLC
Food Long Life Premium Organic Green Tea with Lemongrass, packages of 18 tea bags, (27 grams/.95 ounces) Lot number 2165 -- UPC 713757555302 Expiration 6/13/14 (may or may not be printed on the product packaging) Class II Recall is being conducted based on a finding of possible contamination by the supplier of the firm's lemongrass. Custom Co-Pak, LLC
Veterinary Showmaster S-Series Show Lamb Feed (BW). Cargill Animal Nutrition, General Office, Minneapolis, MN 55440. UPC 7 22304 28992 8 50 lb bag 38306326464, 38306726610, and 38307426757 Lot code consists of four components: 38 - 3 - 063 - 26464 38= location code 38 = Burlington, WA 3 = year (2013) 063 = julian date code (63rd day of the year = March 4th) 26464 = represents the production run and is sequential run number from the batching  ...
More
Class I The animal feed was manufactured with the incorrect concentration of sodium molybdate (molybdenum) thereby having an excessive amount of molybdenum. Cargill Animal Nutrition
Devices Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. Lots 1194944 and 1198342 Class III Use of affected lots may give false indication of susceptibility to Nitrofurantoin. Remel Inc
Devices 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician. Serial numbers - TM-001065, TM-001283, TM-001284, TM-001325, TM-001411, TM-001426, TM-001465, TM-001476, TM-001529, TM-001967, TM-001968, TM-001975, TM-001985, TM-002015, TM-002016, TM-002017, TM-002018, TM-002021, TM-002022, TM-002095, TM-000015, TM-000028, TM-000031, TM-000041, TM-0048, TM-000050, TM-000051, TM-000053, TM-000055, TM-000059, TM-000064, TM-000065, TM-000068, TM-0069, TM-000213, TM-000215, TM-000218, TM-000219, TM-000070, TM-000072, TM-000074, TM-000075, TM-000078, TM-000081, TM-000082, TM-000083, TM-000085,  ...
More
Class II Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall does not affect the CombiSet Bloodlines or 50 mg Venofer(R) vials. The 50 mg Venofer(R) vial can continue to be used for manual drug delivery via syringe. Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Drugs Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50 Lot #: 6103882, Exp 10/14 Class I Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. Fresenius Kabi USA, LLC
Drugs Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA Lot #CABDAHAC:39, Exp. Date: 5/8/2013; Lot #CABDAGAC:58, Exp. Date: 4/13/2013;  ...
More
Class II Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W036809231339; W036809231339; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036813800475; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036813039581; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813039581; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W035413025254; Class III Blood product, not labeled with a tag indicating that it contained anti-D, was distributed. Community Blood Center
Biologics Blood and Blood Products for Reprocessing 053GR07822; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Amer. National Red Cross-Greater Chesapeake & Potomac Reg.
Biologics Source Plasma 0540305112; 0540299878; 0540299123; 0540298708; 0540297984; 0540297639; 0540297010; 0540296696; 0540302044; 0540301329; 0540300997; 0540300333; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Biomat USA, Inc.
Biologics Source Plasma 12TTXC9869; Class II Blood product, collected from a donor who was allowed to donate without a current physical, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced W117013227633; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Blood Centers of the Pacific - Irwin Center
Biologics Red Blood Cells Leukocytes Reduced W201913001505; W201913001495; W201913001508; W201913001499; Class II Blood products, collected using an inadequate reagent to perform the arm scrub, were distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Platelets Pheresis Leukocytes Reduced W115113080709L; W115113080709L; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W115113098152E; Class III Blood product, labeled with an extended expiration date, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Biologics Platelets Pheresis W115113072408A; W115113072408A; Class II Blood products, labeled leukoreduced which had not undergone leukoreduction, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W115113088151B; W115113088151B; Class II Blood products, collected without the performance of a WBC count during instrument re-validation, were distributed. Lifesouth Community Blood Centers, Inc. - Mobile Region
Biologics Fresh Frozen Plasma (Apheresis) W043813700005; W043813700005; W043813700005; Class III Blood products, collected in an expired triple transfer pack, were distributed. LifeShare Community Blood Services
Biologics Platelets Pheresis Leukocytes Reduced W115113056447X; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Red Blood Cells Leukocytes Reduced W069112156683; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069112156683; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W241213800142; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Wellmont Health System Dba Marsh Regional Blood Center
Biologics Red Blood Cells (Apheresis) W036813029167; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036813029167; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Drugs Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York Lot #: 120514, EXP: 12/2014 Class I Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug. Bethel Nutritional Consulting, Inc
Drugs ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9. Lot #: 13A026, Exp 01/15 Class I Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets. Advance Pharmaceutical Inc
Devices Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant. 60621340 60621339 60621342 60621345 60639475 60621341 60621338 60621344 60671954 60653031 60653066 60671958 60639474 60653032 60653043 60653053 60653063 60671956 60671957 60705048 60653057 60653069 60671955 60621343 60705047 60714810 60705044 60701995 60705045 60701998 60702002 60705043 60702006 60680439 60736748 60781210 60781213 60781212 60781211 60782044 60782047 60782049 60705046 60714808 60782048 60782043 60782050 60736749 60714809 60736750 60782046 60736752 60736753 60736756 60782040 60782045 60736754 60781209 60782041 60812142 60812145 60782037 60812143 60812147 60815943 60564710 60812146 60817011 60782042 60812141 60812144 60812148 60815946 60830649 60830650 60830670 60830652 60572991 60736755 60736758 60862361 60862362 60862363 60862364 60862365 60862366 60862367 60879681 60862369 60879678 60862368 60564708 60915347 60931209 60931208 60931211 60931212 60931213 60931215 60973693 60973694 61026401 61026409 61026399 61026402 61026406 61026414 61026415 61026405 61026403 61026407 61026404 61045321 61026411 61037587 61037589 61037588 61037586 61037590 61037591 61063230 61069128 61063232 61069129 61069131 61069132 61077253 61083091 61083092 61083093 61077251 61108038 61110037 61110038 61114907 60879682 61120993 61120992 61141516 61141512 61141515 61141517 61142760 61141513 61141514 61142759 61142761 61142762 61171562 61171564 61171565 61184407 61184409 61184410 61141518 61142763 61179647 61184408 61195103 61184405 61184406 61195101 61195104 61195097 61195095 61195096 61195102 61195094 61195099 61195098 61209057 61275454 61251129 61251131 61209056 61209053 61275452 61278174 61278175 61278176 61284325 61284326 61284327 61284328 61286932 61274845 61209054 61209055 61251130 61278171 61284322 61284324 61286935 61286938 61286940 61195093 61278172 61278173 61275456 61268917 61278177 61399023 61310083 61345993 61393376 61400219 61345995 61379219 61405653 61420626 61420628 61420629 61420631 61405652 61466805 61466807 61466808 61466814 61428488 61466840 61428485 61502706 61466842 61491356 61502705 61534196 61491355 61609889 61625237 61614765 61609887 61616173 61609888 61589581 61663369 61663371 61663372 61663373 61663375 61629793 61644214 61663376 61762401 61769259 61700052 61762403 61762486 61762492 61784953 61798403 61828057 61849821 61906712 62046409 62106371 62120939 62120941 62124273 62197640 62197642 Class II Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Zimmer, Inc.
Devices Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw, orthopedic implant. 60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 61169420 61198462 61264756 61269944 61198455 61162618 61179754 61179757 61198458 61198460 61198461 61209574 61198456 61209572 61209573 61198457 61264754 61269949 61264753 61198459 61286925 61288126 61294831 61246085 61264748 61286923 61286928 61294832 61294833 61304496 61264749 61264750 61286930 61326116 61264752 61264751 61294834 61341158 61352935 61294835 61352934 61352936 61359996 61359995 61359994 61420344 61420343 61412173 61375175 61436467 61377328 61377330 61379892 61402004 61402005 61402007 61440257 61440688 61375177 61437988 61440689 61457772 61379890 61379891 61437989 61463554 61463555 61440690 61453112 61464380 61457773 61464381 61453111 61463557 61464379 61408293 61473803 61512406 61523582 61523859 61529230 61538716 61542608 61542610 61542611 61558660 61558661 61565485 61565484 61565488 61565486 61565487 61565489 61585377 61578712 61584969 61590989 61590993 61590994 61602063 61613172 61602064 61621833 61628735 61621843 61635176 61621834 61621838 61621842 61640885 61640886 61640887 61700444 61682532 61682545 61672121 61682542 61682544 61682546 61717286 61714071 61719312 61746531 61719308 61719314 61752596 61752594 61752599 61752602 61753041 61761524 61682547 61753042 61753043 61756193 61853082 61870425 61888704 61902191 61990140 62271890 62271887 Class II Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Zimmer, Inc.
Devices VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. Versa-Fx Femoral Fixation System, orthopedic implant. 60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823 60612832 60629948 60629756 60629755 60629950 60560744 60621346 60621347 60621348 60621350 60612826 60621349 60621351 60621353 60585244 60612820 60612830 60621354 60621356 60621357 60612825 60612829 60612831 60653083 60653092 60653075 60653078 60653085 60653088 60653100 60653111 60539408 60539409 60653095 60653098 60653107 60653110 60653114  ...
More
Class II Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Zimmer, Inc.
Devices VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. Orthopedic implant. 60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497 60632504 60632506 60646243 60632516 60632527 60646247 60632505 60632514 60646241 60646245 60646256 60648988 60648990 60630045 60646250 60646257 60646260 60646261 60630097 60646251 60664579 60666551 60666553 60630101  ...
More
Class II Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Zimmer, Inc.
Devices VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150). Orthopedic implant. 60619089 60619099 60611043 60619098 60611039 60632532 60668205 60668241 60669598 60668240 60668247 60685095 60685102 60679344 60685066 60685104 60685096 60674425 60704366 60704367 60704370 60714913 60704368 60714914 60714915 60714916 60726325 60744850 60714917 60726326 60754395 60763214 60763215 60763216 60787010 60787191 60787194 60787198 60787190 60787192 60787193 60787196 60787199 60787197 60787189 60803585 60807846 60807848 60803584 60787195 60815493 60845778 60845777 60844062 60868471 60877490 60877489 60885169 60885171 60911343 60932392 60932393 60938417 60938419 60943339 60938421 60944523 60787188 60972802 60972803 60998290 61005007 60972801 61020337 61020339 61020335 61037487 61037488 61037489 61041090 61037490 61027502 61027507 61027516 61041091 61027510 61027523 61027511 60868468 61076083 61086851 61041093 61092223 61092239 61092241 61103196 61103197 61103198 61103201 61101549 61103199 61101547 61041089 61140177 61162619 61162620 61169415 61169416 61169417 61179752 61169418 61198454 61223003 61162621 61092237 61228339 61264745 61264742 61264746 61294830 61286877 61304472 61286880 61309349 61309350 61286879 61341982 61341983 61357166 61357172 61357171 61359993 61286878 61446407 61456386 61375171 61458224 61459335 61474332 61464382 61476801 61476802 61476803 61427113 61427114 61475572 61427115 61474333 61474334 61482163 61482164 61453113 61493898 61511595 61516366 61516367 61523581 61542781 61538715 61542606 61551564 61565482 61565483 61584968 61578708 61596986 61613171 61590988 61596985 61619259 61631410 61631417 61631426 61619260 61640888 61635177 61640895 61640889 61640890 61672132 61672134 61640891 61672127 61708338 61708350 61714083 61729213 61748334 61749017 61749009 61749012 61749027 61758148 61804344 61861311 62105419 62271938 62271936 62271934 62310747 Class II Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. Zimmer, Inc.
Devices Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. Part number J8301-F Class II The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. If a screw passes through the VA-LCP plate, additional medical intervention during the index procedure could be needed. Synthes USA HQ, Inc.
Devices Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use. Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international). Class II Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot well, the first sample will always be QC or calibrator from a Vista vial. Patient sample will never be dispensed into an aliquot well that contains another patient sample. The possible combinations are 1.) patient sample dispensed on QC or calibrator from a Vista vial, 2) QC from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial, and 3) Calibrator from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial. Siemens Healthcare Diagnostics, Inc.
Devices PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31; Product Code/Lot # LKPS1 425,  ...
More
Class II Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias. Siemens Healthcare Diagnostics
Devices Synthes Trauma Nail System. The devices are indication for bone fixation. Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897 Class II Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. Synthes USA HQ, Inc.
Devices Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589. Class II The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver. Alphatec Spine, Inc.
Devices 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate. Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096. Class II Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fracture during use which may result in the device being unable to remove the Glenosphere. There have been 17 reported complaints of the device failing to provide impact and 8 reported complaints of the foot fracturing. In the U.S.,these devices were distributed between March 13, 2006 and March 22, 2013. Zimmer, Inc.
Food Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***"; 2) "****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***" no codes assigned Class II Undeclared allergens: soy oil D'Aqui Manufacturing Products, Corp., Dba Postres de Aqui
Devices DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen. All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF  ...
More
Class II DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device. DeRoyal Industries Inc
Devices Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures. Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense Class II The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use. MCKESSON TECHNOLOGIES INC
Devices HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests. Catalog #18081020, Lot #1368760 & Lot #1312093 Class II Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. Life Technologies Corporation
Devices BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures. Part No. 43410 Class II The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. Brainlab AG
Devices PrepStain AG. For use in the screening and detection of cervical cancer. Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. Becton Dickinson & Co.
Devices PrepStain Tecan US-I. For use in the screening and detection of cervical cancer. Catalog Numbers - 799-13000-00 and 799-13000-00R Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. Becton Dickinson & Co.
Devices PrepStain Tecan US-II. For use in the screening and detection of cervical cancer. Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407) Class II PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. Becton Dickinson & Co.
Devices Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation. Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238 Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229, IC01230, IC01239, IC01240, IC01245, IC01246, IC01270 Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202,  ...
More
Class II Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery. Stryker Craniomaxillofacial Division
Devices Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509. Class II The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. Siemens Medical Solutions USA, Inc
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208030, B225121 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208031 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B226105, B128103 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208032 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208033 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208034 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208035 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B048087, B225117 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208036, B225081 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B226103, B051034 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208089, B225125 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B209033, B225119 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B209034, B225123 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B209035, B225120 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B208037, B225126 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B225082, B126052 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B225116, B128075 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B225114, B051033, B103049 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B225118, B101171 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B225115, B048089, B102030 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg Lots: B206025, B048090, B101172 Class II The trial stems were manufactured using the wrong design. Waldemar Link GmbH & Co. KG (Corp. Hq.)
Devices Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18  ...
More
Class II Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "Patients in whom dual antiplatelet therapy (aspirin and clopidorel) is contraindicated." Micro Therapeutics Inc, Dba Ev3 Neurovascular
Devices Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery. Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006. Class II As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases. Integra Limited
Devices Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948,  ...
More
Class II Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455. Class II Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. Medtronic Inc. Cardiac Rhythm Disease Management
Devices Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637,  ...
More
Class II Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. Medtronic Inc. Cardiac Rhythm Disease Management
Devices SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number HMO-W264 Lot Number F2290966 Expiration Date: 02/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number DOA-254 Lot Number DOA2050035 DOA2090666 DOA2110059 DOA2120771 Expiration Date: 02/2014 07/2014 08/2014 10/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number DTH-114 Lot Number THC1120052 THC2120005 THC211100044 THC2100044 THC2120006 Expiration Date: 12/2013 10/2014 09/2014 09/2014 11/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number DCO-114 Lot Number COC2010004 COC2110076 Expiration Date: 12/2013 09/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number DMA-114 Lot Number MET2100027 Expiration Date: 08/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Manufacturer's Product Number DOP-114 Lot Number OPI2100003 Expiration Date: 09/2014 Class II These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and incorrect test results. Sarken, Inc.
Devices PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A 08632296* Tabletop, 550TxT, TT-S 10046140 Class II Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off. Siemens Medical Solutions USA, Inc
Devices ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319 Class II Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided. Zimmer, Inc.
Devices ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts. All serial numbers Class II The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures. Siemens Healthcare Diagnostics
Drugs Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02 a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14 Class II Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination. Nexus Pharmaceuticals Inc
Food Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market All best buy dates sold at Whole Food Market Stores in Louisiana, Oklahoma, Texas, Ohio, Virginia, Washington D.C., Illinois, Indiana, Michigan, Missouri, Nebraska, Wisconsin, California, Hawaii, Arizona, Nevada (Reno Store Only) Class I The product has the potential to be contaminated with Listeria monocytogenes. This recall is in response to the Trois Comtois in Poligny, France recall. Whole Foods Market
Devices NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. version 1.1.0; serial numbers: 320823 320425 320622 121424 320094 320606 320617 320577 320636 320630 320468 320489 320518 320695 320695 320652 320666 320692 320675 320640 320492 320695 320704 320777 320779 320771 320768 320753 320744 320780 320617; version 1.2.1; serial numbers 320740 120045; Version 1.3.0: 141356 320814 320815 140941 141326 320847 320916 320906 320203 320569 320809 320813 141357 320831 140937 141358 320798 320090 320980 320990 320927 320942 320920 141401 320983; Version 1.3.4; 321035 321020 320998 141453; Version 1.3.5: 380215 380188 380189 380251 380211 380014 380077 380213 380076 380034 380035 380017 380244 380124 380243 380075 380122 380021 380253/380052 380221/380214 141480 141471 321053 320883. Class II Under certain circumstances, the Left eye image may be saved as the Right eye image. Nidek Inc
Food Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated 949038 Class I FDA analysis of Morbier Semi-Soft Cheese (prior to entry) revealed the presence of Listeria Monocytogenes. Les 3 Comtois is recalling the cheese from the same lot that was allowed entry and further distributed in the US. Les 3 Comtois
Devices OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 µM) and KCL (300 µM. 10.0ml.) PN: 50003300; Store at d - 15°C. Product Usage: General Purpose Reagent for laboratory use. Lot numbers: 10016853, 10017390, 10020343, 10021820 and 10022594. Expiry dates 12/5/2010, 06/15/2012, 09/08,2012, 08/13/2013 and 02/21/2014. Class III The package insert for FG OLA Buffer, GPR displayed the wrong concentration of µM instead of the correct mM unit. Celera Corporation
Devices GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system. software versions 6.2, 6.2.1, 6.3, and 6.3.1 Class II GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21, which potentially results in an inaccurate consultation of the patient. GE Healthcare, LLC
Devices ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system. Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063 Class II Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device. Roche Diagnostics Operations, Inc.
Devices Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones. Part No. 02.111.730, with Lot No. 3614792 Class II The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate. Synthes USA HQ, Inc.
Devices Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use. Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit Class II Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. Stryker Howmedica Osteonics Corp.
Food "***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***" 392-07 Class III Positive test results for Generic E. coli Quesos Vaca Negra, Inc.
Devices Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument. Catalog #6541-2-609 All lot codes Class II Stryker Orthopaedics has received complaints associated with cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. Stryker Howmedica Osteonics Corp.
Food Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled. Lot 09000101, 07/22/13 on cardboard bin (box) Class I Heeren Brothers Produce is recalling Athena cantaloupes distributed to small independent grocers in Michigan July 23-26, after routine testing by FDA found product contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, the elderly or others with weak immune systems. Healthy individuals may suffer short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain or diarrhea. Listeria can cause miscarriages and stillbirths in pregnant women. Heeren Bros Inc
Drugs Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03 Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016 Class II Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification. Teva Pharmaceuticals USA, Inc.
Devices 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth. Product Code 902150 (Kit) · Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) · Lot Codes N486012, N497616 (not distributed) and N483920 Class II 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge. 3M Company/3m Espe Dental Products
Devices SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow. Lot # 22754F16 and #25854I17 Class II SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. SpineNet
Devices SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level Ref. No. CL1012-05 Size 10mm x 12mm x 5mm, Ref. No. CL1012-06 Size 10mm x 12mm x 6mm, Ref. No. CL1012-07 Size 10mm x 12mm x 7mm, Ref. No. CL1012-08 Size 10mm x 12mm x 8mm, Ref. No. CL1012-09 Size 10mm x 12mm x 9mm, Ref. No. CL1012-10 Size 10mm x 12mm x 10mm, Ref. No.  ...
More
Class II The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing. SpineNet
Devices Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics. 437765/SN09000009, 452854/SN10000003, 463879/SN10000016, 500643/SN12000006,504710/SN12000011, 511454/SN12000018, 519869/SN13000005, 524432/SN13000007, 500643/SN12000006, 436570/SN09000008, 511492/SN12000019, SN09020039, SN09010077, 438946/SN09000011, SN10002064, SN11020126, SN12020282, 516048/SN12000021, SN13020163, 524411/SN13000011, 409205/SN08000002, 438474/SN09000040, 448425/SN10000001, 449743/SN10000010, 461559/SN10000014, 493489/SN11000008, 496231/SN12000003, 434381/SN09000005, 456026/SN10000011, 465845/SN11000005, 471608/SN11000001, 481912/SN11000004, 508150/SN12000015, 524367/SN13000009, 524510/SN13000010, SN07020246, 485916/SN11000007, 428148/SN09000006, 423585/SN09000003, 500351/SN12000009, 506215/SN12000012, 520201/SN13000003, 409442/SN08000003, 419279/SN09000001, 518054/SN13000001, 460532/SN10000013, SN09020304, 443304/SN09000012, 443310/SN09000013, 416734/SN08000005, 420531/SN09000002, 423195/SN09000004, 460544/SN10000017, 454997/SN10000009, 496323/SN12000002, 496324/SN12000001, 399965/SN08000001, 438232/SN09000010, SN09020302, 443840/SN09000014, 452406/SN10000004,  ...
More
Class II The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. Philips Healthcare Inc.
Drugs Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3. Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013 Class II Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component. Novocol Pharmaceutical of Canada
Veterinary Sparhawk Laboratories, Inc. Atropine Sulfate 1/120 Injectable Solution, each mL of sterile solution contains 0.54 mg. atropine sulfate, packaged in 100-ml. vials, RX, Manufactured for Sparhawk Laboratories, Inc., Lenexa, KS. Lot number 120078, Exp. 11/2013 Class II The lot failed stability at the 12-mo. testing interval (low). Sparhawk Laboratories Inc
Devices E-Z Clean® Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek® - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. Model: 0100L, Lots: 131508, 131945, 132167, 132396 Model: 0100LS, Lots: 131509, 131946, 132058 Class II Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation. Megadyne Medical Products, Inc.
Food Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608 All units with sell by date prior to 8/14/13 and pack date prior to 8/10/13. Class I Egg wash is used on the product and is not listed on the ingredient list or allergen statement. Whole Foods Market
Food Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) UPC: 0216733009993 Whole Foods Market Inc., Emeryville, CA 94608 All units with sell by date prior to 8/14/13 and pack date prior to 8/10/13. Class I Egg wash is used on the product and is not listed on the ingredient list or allergen statement. Whole Foods Market
Food Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle, ID 83616 Product of Bolivia a) Net Wt 2 lbs. - UPC 897034002267 b) Net Wt 4 lbs.- UPC 897034002021 packaged in re-sealable bags a) Net wt 32 oz - UPC 897034002267 Item no. G511002267 Best Buy Date 2/11/14, 02/12/14, 02/13/14, 02/14/14 b) Net wt 4 lbs - UPC 897034002021 Item no. G5914202 - Best Buy Date 02/02/14 Class III Nature's Earthly Choice Organic Quinoa may contain sand and grit. Global Juices & Fruits LLC
Devices GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. Mfg Lot or Serial # AAB04397901GR SD007210479GR SD007231230GR SD007241751GR SD007366729GR SD007387285GR SD007387288GR SD007387291GR SD007387292GR SD007387294GR SD007439614GR SD008056174GR SD008076950GR SD008087478GR SD008138396GR SD008168769GR SD008219818GR SD008219821GR SD008356627GR SD008388272GR SD008388551GR SD008419461GR SD008419463GR SD008419495GR SD008421124GR SD008429787GR SD008429950GR SD008452355GR SD008452399GR SD008463177GR SD008516155GR SD008516281GR SD009037533GR SD009047690GR SD009088931GR SD009088944GR SD009099025GR SD009119669GR SD009121032GR SD009121171GR SD009129978GR SD009141371GA SD009141699GR SD009151940GA SD009182687GR  ...
More
Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Devices SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA  ...
More
Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Devices GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA SBB12361656GA SBB12361658GA SBB12361659GA SBB12361660GA SBB12361661GA SBB12361662GA SBB12361663GA SBB12301635GA RT411220584GA RT412081484GA RT412091488GA RT412091501GA RT412101576GA RT412101599GA RT412101601GA RT412101604GA RT412101605GA RT412101606GA RT412101609GA RT412101611GA RT412101621GA RT412101624GA RT412101626GA RT412101628GA RT412101629GA RT412101632GA RT412101646GA RT412101655GA RT412101657GA RT412101661GA  ...
More
Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Food Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9 Lot # 02D312A4 Class I The firm was notified by one of their customers of a positive Listeria monocytogenes results they received from the Michigan Department of Agriculture. Buurma Farms Inc
Food See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016 8 oz UPC: 737666094479. Stock boxes SKU 9458. These are ~ 3.78 lb boxes sent to stores where they are packed into 8 oz bags. KSU 9447 - 1- lb.cases of 8oz x 20 bags sent to licensees. Class I Investigation into a consumer complaint revealed that "milk: had been erroneously omitted from the ingredient statement of Dark Chocolate covered Blueberries. See's Candies Inc.
Drugs Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 Lot 25048DK Exp. 01/15 Class II Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Hospira, Inc.
Drugs buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. Lot #: CA2D14A, CA2D15A, Exp 12/13; CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14; CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14; CF2D01A, CF2D02A, CF2D03A, Exp 05/14; CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14; CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14; CJ2D10A, CJ2D11A, Exp 08/14 Class III Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint. Actavis South Atlantic LLC
Drugs Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 Lot: 23-505-EV, Exp. 11/14 Class II Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. Hospira Inc.
Food Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716. UPC: 0 78742 00844 8 Class II Undeclared ingredient; Yellow #5 & #6. Ann's House of Nuts, Inc
Show all Code Info
-
-