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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced LF32600 Class II Blood product, for which the quality control testing for red blood cell volume was not performed, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced FZ77035 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced FZ85617 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Tri-counties Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced Irradiated GW97725 Class II Blood product, which may have been out of controlled storage for greater than 30 minutes, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced FZ80940, FZ84236 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced. 24FP04503; 24FP04503 Class II Blood products, held in quarantine pending results of an investigation, were distributed American National Red Cross (The)
Biologics Source Plasma 4080095992, 4080114685, 4080107999, 4080106384, 4080105847, 4080098437, 4080096586 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Csl Plasma
Biologics Source Plasma 4080141558, 4080140651, 4080140149, 4080127236, 4080125772, 4080124313, 4080123731 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. Csl Plasma
Biologics Red Blood Cells Leukocytes Reduced 042K90931 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 042K90931 (pool 1997) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 042K90931 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42X20495 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 42X20495 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 42X20495 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42FX51417, 42M22729 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 42FX51417, 42M22729 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 42FX51417, 42M22729 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 07RMIB5916 Class II Blood product, collected from a donor who reported post donation information regarding IV drug use, was distributed. BioLife Plasma Services L.P.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 2069982 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed Central Kentucky Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 2086318; 1998668; 2019185; 2024609 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed Central Kentucky Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced LF32774 Class III Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Irradiated P57203 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Fresh Frozen Plasma. P57203 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Red Blood Cells 06GY28769; 06GY28770 Class II Blood products, tested for communicable diseases using unsuitable samples, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 042E48603 Class II Blood products, which did not undergo the required quality control testing, were distributed. American National Red Cross (The)
Biologics Source Plasma 05RCAB4721 Class II Blood product, which was not quarantined after receiving information regarding the donor's contact with a person who tested reactive for HBsAg, was distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 06SUTA7770, 06SUTA7236, 06SUTA6923 Class II Blood products, which were not quarantined after receiving information regarding a risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. BioLife Plasma Services L.P.
Biologics Fresh Frozen Plasma 3594412 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Presbyterian Intercommunity Hospital, Inc. Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 042FP20630 Class III Blood product, with donor hematocrit determined using an analyzer for which the normal control was out of range, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 16GM57521 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 16GM57521 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 50KW03215 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells FS14433 Class II Blood product, collected from a donor during a one year period of deferral for travel to a malarial endemic area. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced GZ11666; GZ11666 Class II Blood products, quality control and distribution of products which did not meet specifications, were distributed. . Tri-counties Blood Bank
Biologics Red Blood Cells (Apheresis) 06FS23078 , 06LF90461, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 06FM42146, 06FM42698, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06LC12397, 06LK96510, 06LQ82947, 06FP66382, 06GS22086, 06GV57858, 06LQ83398, 06GW37271, 06GF50169, 06GE22291, 06GS23145, 06LF92077, 06GF51447, 084FT13509, 084J 21960, 084KM77737, 084T48723, 084T49156, 07FC33547, 07GT00491, 07GJ28906, 07FJ97037, 07FY72624,06FT00807, 06LE43292, 06FT01385, 06FE13059, 06FM42146, 084K00268, 07FC33546 Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed.. American National Red Cross (The)
Biologics Cryoprecipitated AHF 06FS23078, 06FP66382, 06GW37271, 06GS23145, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 06KR54131, 06KR54178, 06KR54290,06KG50494, 06KR54131, 06KR54178, 06KR54290, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Cryoprecipitate Poor Reduced 06GW37271,06GS23145, 084K00351, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours 06LK96510, 06LE43292, 06GV57858, 06GF50169, 06FE13059, 084FT13509, 07FY72624, 06LQ82947,06FM42146,06GE22291, 084J 21960, 084KM77737, 084K00268, 07FC33546,07FJ97037, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 06KG50494, 06KR54131, 06KR54178,06KR54290, 06GS22086, 06LQ83398,084T48723, 084T49156, 07GT00491,07GJ28906, Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 07SWIC5381 Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 52947810 ,52952302 ,52985348 ,52992261 ,52996900 , 53000354 ,53353603 ,53665614 ,53890016 ,54143128 , 57567679 ,57569635 ,61844841 ,61849853 ,62426619 , 62534192 ,62538435 ,62540117 ,62940078 ,62980616 , 63409383 ,63673265 ,63683431 ,63687392 ,63955064 , 63960624 ,63960846 ,63961997 ,63968668 ,64360294 , 64428642 ,64428680 ,64432625 ,64432649 ,64435985 , 64436012 ,64438764 ,64438771 ,64830100 ,65039977 , 65041956 ,65045268 ,65059777 ,65062838 ,65065402 , 65346020 ,65601594 ,65631010 ,65765173 ,65979266  ...
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Class III Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 07FY74209 Class II Blood product, in which donor gave history which warranted deferral or follow up questions was not asked, was distributed. American National Red Cross (The)
Drugs Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). No lot codes are printed on the product Class I Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug. Chang Kwung Products
Drugs Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8). No lot codes are printed on the product Class I Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug. Chang Kwung Products
Biologics Source Plasma 0230303925 0230288437 0230286392 0230264093 0230263403 0230262523 0230227677 0230217519 0230216931 0230215526 0230213763 0230213156 0230212633 0230211886 0230210832 0230205537 0230203735 0230202941 0230202048 0230201656 0230184950 0230184135 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Biomat USA, Inc.
Biologics Source Plasma 6240281727, 6240279727, 6240279034, 6240276220, 6240274982, 6240269240, 6240268017, 6240265756, 6240263938, 6240261729, 6240260270, 6240258649, 6240257869, 6240255932, 6240255078, 6240253287, 6240252535, 6240250203, 6240249354, 6240247835, 6240246792, 6240245034, 6240244209, 6240242549, 6240241771, 6240240130, 6240239304 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. CSL Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W14281041940100E, W14281041940200C, W142810419404008, W142810419405006, W142810419406004, W142810419407002, W14281041940900Z, W14281041941000C, W14281041941100A, W142810419412008, W142810419413006, W142810419416000, W14281041941700Z, W14281041941800X, W14281041941900V, W142810419420008, W142810419421006, W142810419422004, W142810419423002, W14281041942500Z, W14281041942600X, W14281041942700V, W14281041942800T, W142810419430004, W142810419431002, W142810419432000, W14281041943300Z, W14281041943400X, W14281041943500V, W14281041943600T, W14281041943700R, W14281041943800P. Class III Blood products, which labels were applied to products with incorrect or missing information, were distributed. Tri-Counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W142810419408000, W142810419415002, W14281041942900R. Class III Blood products, which labels were applied to products with incorrect or missing information, were distributed. Tri-Counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated W142810419414004, W14281041940300A Class III Blood products, which labels were applied to products with incorrect or missing information, were distributed. Tri-Counties Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W14281041942900R, W142810419408000, W142810419415002. Class III Blood products, which labels were applied to products with incorrect or missing information, were distributed. Tri-Counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated W045110210942; W045110203566; W045111231320; W045110199254; W045110209874; W045110209932; W045110213116; W045110193473; W045110218893; W045110216742; W045110222062; W045111228903; W045111232508; W045111245749; W045111228354; W045111240957; W045111235642; W045111240428; W045110218213; W045111240860; W045111245139; W045110222102 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced W045110198384; W045111231311; W045111235643; W045110213388; W045110202176; W045110200571; W045110213387; W045111231336; W045111228340; W045111241714; W045110202805; W045110208558; W045110211561; W045110193447; W045110208176; W045110198517; W045110198671; W045110198484; W045110213121; W045110211930; W045110198834; W045110198841; W045110199767; W045110198553; W045110198519; W045110198666; W045110202815; W045110198445; W045110203531; W045110199174; W045110203569; W045110203557; W045110209301; W045110209333; W045110208572; W045110208591; W045110208563; W045110209870; W045110213140; W045110203742; W045110205970; W045110199773; W045110200191; W045110200227; W045110198504; W045110198571; W045110198637; W045110198383; W045110202822; W045110202829;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Plasma Frozen within 24 hours W045110218862; W045110218228; W045110219150; W045110219133; W045110210656; W045111228041; W045111229352; W045111229346; W045111229357; W045111225190; W045111231079; W045111233272; W045111232665; W045110218231; W045110200646; W045110218881; W045110218871; W045110213441; W045111224033; W045111225176; W045111233944; W045111232672; W045111233256; W045110200597; W045110210605; W045111228038; W045111232153; W045111243753; W045111234996; W045111234965; W045110218220; W045110219117; W045110220269; W045110220275; W045110218888; W045110210954; W045110213390; W045110213380; W045110213399; W045111232147; W045111232146; W045111231101; W045111233997; W045111233034; W045111233048; W045111243759; W045111243767; W045110218217; W045110218885; W045110210950; W045110216721; W045110222097;  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Plasma Cryoprecipitate Reduced W045110211561 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Biologics Cryoprecipitated AHF W045110216936; W045110216976; W045110216972; W045110222052; W045110222044; W045111228051; W045111228062; W045110222050; W045110222062; W045110213116; W045110216287; W045110222033; W045110200227; W045110203577; W045110203564; W045110211561; W045110210939; W045110216275; W045110216748; W045110216915; W045111228060; W045111240917 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. Community Blood Center of the Ozarks
Devices Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers Class II ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences. Arjo, Inc. dba ArjoHuntleigh
Devices Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling. Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers Class II ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences. Arjo, Inc. dba ArjoHuntleigh
Devices Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories. Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925. Class II Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve. Beckman Coulter Inc.
Drugs Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. Lot #: 99515, Exp 09/2016 Class I Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol. Reumofan Plus USA
Devices VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. Cat#750-600; PN 05342716001; Serial #'s: 310724, 310735, 311187, 312055, 310373, 311052, 311171, 311953, 310750, 311266, 311267, 311564, 311565, 311596, 311304, 310481, 311924, 310607, 311627, 310527, 311436, 311742, 310132, 311432, 310034, 310408, 310687, 310697, 311343, 311958, 310728, 310778, 311991, 312070, 310471, 311326, 311952, 310103, 310777, 311446, 310924, 311303, 311528, 310490, 310913,  ...
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Class II Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component. Ventana Medical Systems Inc
Devices VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents. Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the  ...
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Class II Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component. Ventana Medical Systems Inc
Veterinary Steve's Real Food TURDUCKEN CANINE RECIPE, 5 lbs bags of 8 oz patties, UPC 6-91730-14204-9, Expiration 10/27/13, MFR # 83. Raw Frozen Dog Food, Distributed by Steve's Real Food Inc, Aumsville, OR 97086 Lot B209 Class I Steve's Real Food is recalling certain lots of Turducken Canine Recipe due to possible salmonella contamination. Steve's Real Food, Inc.
Biologics Red Blood Cells Leukocytes Reduced W128712240529 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Delta Blood Bank
Veterinary BARF Juicy Lamb Recipe contains 12 Lamb Patties per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00104 8. Lot 209. USE BY 7/27/2013. Class I BARF Juicy Lamb Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella. JDJ Manufacturing, LLC
Veterinary BARF Juicy Combo Recipe Patties, 12 pieces per bag, 6 lbs. bag, 4 bags per case, sold under BARF brand name. The UPC is 8 37528 00106 2. Lot 209. USE BY 7/27/2013. Class I BARF Juicy Combo Recipe patties from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella. JDJ Manufacturing, LLC
Veterinary Combo Diet Bulk Pack 06306, 24 lbs. bag, sold under BARF brand name. There is no UPC for this item. Lot 209. USE BY 07-27-13 Class I Combo Bulk from lot 209 sold under BARF brand are recalled due to a potential contamination with Salmonella. JDJ Manufacturing, LLC
Veterinary Variety Pack 04107, consists of one retail unit of BARF Combo, Beef, Chicken, and Lamb product. There are total 4 individual units per case. There is NO UPC for this product. Lot 214. USE BY 08-01-13. Individual unit in this case bears LOT# T209, LOT# E212, LOt# E209, and LOT # T214. Class I Variety Pack from lot 214 sold under BARF brand are recalled due to a potential contamination with Salmonella. JDJ Manufacturing, LLC
Drugs 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. Lot #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90 Class I Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates Hospira Inc.
Devices Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System . Lot Number: PM3979 Class II Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter. SpineFrontier, Inc.
Devices Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. 2520301, 2520307 Class II Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference. SpineFrontier, Inc.
Devices T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. Lot Numbers: 1335201A, 1446101A Class II During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. SpineFrontier, Inc.
Devices Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module. Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051. Class II Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells Leukocytes Reduced W12701380967900; W12701380967700; W12701380968200; W12701380950700; W12701380953600; W12701380953400; W12701380953300; W12701380953700; W12701380953800; W12701381096600; W12701381096400; W12701380957500; W12701380705400; W12701380706400; W12701380706000; W12701380705100; W12701380706600; W12701380706100; W12701380707000; W12701380707400; W12701381054200; W12701381052100; W12701381053700; W12701381055400; W12701381052600; W12701381052400; W12701381054500; W12701381051700; W12701380719000; W12701380718200; Class II Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. OneBlood, Inc. dba Southeastern Comm. Blood Center
Devices ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Devices Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Devices Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Devices Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Devices IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Devices IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Per recall strategy. Class II A rare variant of TSH, identified in a small cluster of patients, is not detected. Siemens Healthcare Diagnostics, Inc
Drugs Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0 Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14 Class I Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. Apotex Corp.
Drugs Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01. Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13 Class I Presence of Particulate Matter: Found during examination of retention samples. Sandoz Incorporated
Biologics Cornea SDS130600OSCN; SDS130600ODCN Class II Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. DCI Donor Services dba Sierra Donor Services
Drugs Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. Lot 25394DK, exp. 01/2015 Class II Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot Hospira, Inc.
Devices BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes. Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380. Class II BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume. Becton Dickinson & Company
Devices R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic. Batch No. 12FM00603 Class II One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. Smith & Nephew Inc
Devices R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic. Batch No. 12FM00602 Class II One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner. Smith & Nephew Inc
Drugs Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10 Lot MM5767 Class I Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized. Zydus Pharmaceuticals USA Inc
Drugs Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers. Lot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13 Class II Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health
Drugs Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13 Class II Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health
Drugs No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02 Lot #s 10110263, Exp 2/14; 10114706, Exp 4/14; 10118209, Exp 5/14; 10120253, Exp 7/14; 10123520, Exp 8/14; 10095199, Exp 7/13; 10102536, 11/2013, 10103950, Exp 12/13 Class II Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health
Drugs Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm Lot # 10121996, Exp 7/13 Class II Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health
Devices Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw. Lot/Serial Numbers: 027104, 027105 Class II Device design. SpineFrontier, Inc.
Biologics Cornea 20130190L1; 20130190R1 Class III Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lifepoint, Inc.
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. version 6.01 Class II A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table does not match the default host code in version 6.01 software. Biomerieux Inc
Devices Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. Model Numbers 466F220A and 466F220B. Class I Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards. Cordis Corporation
Devices Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. 5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134, 1131900074, 1200500134, 1203200244, 1210100114, 1131300144, 1131900084, 1200500144, 1203200254, 1210100124, 1131300154, 1131900094, 1200500154, 1203200274, 1210100134, 1131300164, 1131900104, 1200500164, 1203700954, 1210100144, 1131300174, 1131900114, 1200500174, 1203700964, 1210100154, 1131300184, 1131900124, 1200500184, 1203700974, 1210700014, 1131300194, 1132800114, 1200500194, 1203900024, 1210700024, 1131300204, 1132800124, 1200500204, 1204000044, 1210700034, 1131300214, 1132800134, 1201300494, 1204000054,  ...
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Class II A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012. Stryker Instruments Div. of Stryker Corporation
Devices Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. 5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074,  ...
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Class II A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012. Stryker Instruments Div. of Stryker Corporation
Devices Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. 5450-852-000 (Console 230V) with SN: 1134000114, 1206800484 1210900274, 1134000124, 1206800494, 1210900284,1134000134 1206800504, 1210900294, 1134000144, 1206800514, 1210900304, 1134000154, 1206800524, 1211800064, 1134000164, 1206800534, 1211800074, 1134000174, 1206800544, 1211800084, 1134000184, 1208700014, 1211800094, 1134000194, 1208700024, 1212900014, 1134000204, 1208700034, 1213100114, 1201700324, 1208700044, 1213100124, 1201700334, 1208700054, 1213100134, 1201700344, 1209400164, 1213100144, 1201700354, 1209400174, 1213100154, 1201700364, 1209400184,1206500014, 1209400194, 1206500024, 1209400204, 1206500034, and  ...
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Class II A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply saline solution to the end of the handpiece tip. If the irrigation pump stopped, the saline would not be supplied to the tip end, resulting in the loss of the cooling function and potentially cause the tip to heat up. The devices affected were distributed October 13, 2011 through October 19, 2012. Stryker Instruments Div. of Stryker Corporation
Drugs Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01 Lot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15 Class II Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet. American Health Packaging
Drugs Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Teva Pharmaceuticals USA, Inc.
Drugs Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Teva Pharmaceuticals USA, Inc.
Drugs Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Teva Pharmaceuticals USA, Inc.
Drugs MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30 NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015 Class II Presence of Precipitate; potential for incomplete constitution upon addition of diluent. AstraZeneca Pharmaceuticals LP
Devices Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. 1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708 10142044 1296030 1020387 3894811 1083900 10115320 1101500 1102400 1101601 10038966 19995620 3894841 1123000 1135600 1137240 1353400 3894860 1547000 1008565 1186900 6169100 10008460 3894844 1155500 3894711 10032361 10166465 3894702 10046069 10037661 10037647 3894834 3894836 10034261 1297400 1302600 1053000 1317801 3894817 3894797 10163092 10053161 1012161 3895854 10046578 1369040 1005333 1375900 10001956 3894734 3894789 3894833 10047157 1403100 1408700 10010196 3894892 3894765 1433251 1009496 1446000 1438800 1865900 1911872 10010570 19996156 10033408 1589480 1453703 1466600 1453702 6273300 10011620 1470203 1477201 1765300 1025650 10037131 19995384 1915200 1470204 1315403 10044246 1470001 1470202 19995746 6129700 1726300 1505700 10063253 10037742 1131700 10037723 4513601 1520101 1001799 10010451 4538200 10122836 1001783 1553400 1220200 3894705 1907800 1000456 6572500 19996529 10038213 3894830 1843701 10165568 1579040 10035744 10060127 3894819 3895895 1027700 1623400 1012793 10149088 3894849 1492500 1719500 10033426 1677100 1697501 1703300 6237701 1716400 1018653 10011474 1725100 1724300 1252400 6598300 1738700 6606300 10002540 19995700 10047163 1793108 3894718 1797801 10038591 1016746 1079000 1442503 19995670 10032641 1043750 1015768 1812600 1813200 1833900 1842600 1846801 1838401 1027503 1846000 10046982 10049664 10049674 10042072 10158492 10040131 1845700 3872400 3894825 3895883 3894801 3880600 3894722 3894716 3894723 3895875 3888400 6840950 10036536 3894870 1908600 1037000 1012361 19995045 10165422 10165005 10005354 10011455 1933600 3894735 1944700 980 500 10167738 111 10161003 10001154 Class I CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. CareFusion 303, Inc.
Drugs VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06, Lot 69968B 03/14 Class II Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink. West-Ward Pharmaceutical Corp.
Devices Mobiletta Mira Mobile X-ray System Model number 10273100 Class II Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This imposes a potential risk of squeezing the toes of the user or another person. Siemens Medical Solutions USA, Inc
Devices Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R Class II Difficulty removing screws from the Invue caddies. SpineFrontier, Inc.
Devices List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14200-28; Lot Numbers: 022045H, 022055H, 030605H, 201765H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14203-28; Lot Numbers: 030895H, 961465H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14206-28; Lot Numbers: 020695H, 100865H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14207-28; Lot Number: 962295H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14210-28; Lot Number: 053835H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14211-28; Lot Numbers: 052945H, 211855H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14212-28; Lot Numbers: 030575H, 081425H, 090515H, 100905H, 100915H, 102255H, 102265H, 122515H, 122525H, 143405H, 143415H, 152655H, 152665H, 152675H, 161375H, 161385H, 161395H, 170955H, 172025H, 172035H, 172045H, 241805H, 250845H, 251735H, 251745H, 962235H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14217-28; Lot Number: 962255H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Devices List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration List Number: 14219-28; Lot Number: 962245H Class I It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. Hospira Inc.
Drugs Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30 Lot # 3097657, Exp 3/15 Class II Subpotent drug: low fill volume in some of the capsules Sanofi US
Food Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packaged in a glass jar with cork closure. Product labeling reads in part:"earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH DRIVE WESTBOROUGH, MA 01581 1-800-934-1204***". UPC code: 400000290942 Lot #: 060367, 060692, 061252 and 061864 Class I Olde Thompson Inc. Oxnard, CA is recalling Earths Pride Organics: Organic Oregano packaged in a 2.2 oz. glass jar with cork closure, Lot #: 060367, 060692, 061252 and 061864 due to possible contamination by Salmonella. Olde Thompson, Inc.
Devices Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients. TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiation date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14. Class II Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing. Siemens Healthcare Diagnostics, Inc.
Food Sunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz. Lot # 10471 November 1, 2015 3700/01173 Class III Golden Beach Inc. is recalling Sunny Sea Sardines in Tomato Sauce for decomposition. Golden Beach Inc
Devices Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration. Part Number: PDC PN STERVIS (Viscot PN 1437-100) Lot: 061313. Class II PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter. Precision Dynamics Corporation
Food The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part "*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***" Date Code SGE-12/282 and Retail UPC 7 31149 65406 8. Class II Aqua Star Raw Frozen Shrimp Easy-Peel Shell-On, Ready to Cook, 1 lb. plastic bags, date code SGE-12/282 was recalled due to Salmonella. Aqua Star (USA) Corp.
Devices Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart. Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622. Class II Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not fit into a 7F sheath, making any mis-labeled introducer components unusable in a clinical case. Medtronic Inc. Cardiac Rhythm Disease Management
Food Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA The production codes for the Mild Chunky Salsa (UPC 3927759137) are L12142 (Best By Date June 2015) and L04093 (Best By Date October 2015) Class II The firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa. Olam Tomato Processors, Inc.
Food Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA For the Medium Chunky Salsa (UPC 3927759139) is L01313 (Best By Date July 2015) Class II The firm received complaints of large fragments of glass that were found inside the Mild and Medium Chunky Salsa. Olam Tomato Processors, Inc.
Devices MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans. Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213. Class I The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value. Iradimed Corporation
Devices Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs. REF 08310400 - Compat® Nasogastric Feeding Tube 8 French (8Fr) in the following lots: 01413G 02412K 08211Z 08712W 14212U 14611P 21512Y 35411H REF 08310500- Compat® Nasogastric Feeding Tube 12 French (12Fr) in the following lots: 01211AV 01513N 04111D, 04111P, 04111V 05812F 05912F 06313N 21512G 23412BV 34712V 35411U REF 08310600 - Compat® Nasogastric Feeding Tube 10 French (10Fr) in the following lots: 08111M 08712D 10211E 13712W 21512F 05312N Class II Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label. Nestle HealthCare Nutrition
Devices MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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 Serial Numbers #s 201902 and 203901 Class II Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions. MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Food Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA 15328-2809 All codes Class II The firm has issued a recall on Giant Eagle Candy Place Chocolate Covered Peanuts with UPC 3003404313. The product has whey in the ingredients and the label does not clearly state that there is a milk allergen. (only whey is listed in the ingredient statement). Giant Eagle
Drugs Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. Lot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A,  ...
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Class II Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point. West-Ward Pharmaceutical Corp.
Devices CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 101173, 102040, 1020631, 111450, 112092, 112102, 112623, 114833, 114843, 114853, 114863, 114873, 114883, 114843, 114853, 114863, 114873, 114883, 120343, 123542, 124890, 126582, 130313, 130973, 136592, 141962, 145172, 149421, 149742, 149752, 149762, 149772, 149992, 154192, 158761, 165422, 169961, 170232, 172572, 177182, 180302, 183821, 193150, 193542, 198062, 204742,207610, 228372,  ...
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Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #: 208351 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 175770 and 209340 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 123120 and 324880 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 218620, 354840, 546660, 115451, 223771, 285451, 324201, 366061, 193702, 227822, 263592, 302572, 123313, 123293, 123303 123313, 123283, and 28955 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 121860, 141870, 145000, and 147910 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Devices Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 100253, 103163, 105082, 109110, 111711, 114813, 120250, 123273, 126652, 130303, 142072, 144902, 144912, 144932, 144942, 144952, 144962, 144982, 144992, 145002, 145012, 145022, 145032, 145042, 145052, 145062, 145412, 1453470, 154452, 158512, 163272, 168391, 184482, 190112, 191830, 204872, 214272, 223482, 225511, 225820, 234871, 235941, 237882, 238041, 242061, 248891, 264180,  ...
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Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. ASO, LLC
Drugs Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01 Lot # N07321, Exp 6/14 Class II Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules Teva Pharmaceuticals USA, Inc.
Devices TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brønshøj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. TCM4 series Base Units: 000-154, 391-876, 391-878 and 391-880 below R0175N009 & Power Supply (Spare part): 910-246. Serial #: 154R0002N002, 154R0004N003, 154R0004N008, 154R0005N004, 154R0005N005, 154R0005N005-U, 154R0005N006-154R0005N006, 154R0006N005, 154R0006N006, 154R0006N008-154R0006N010, 154R0007N001-154R0007N010, 154R0008N001, 154R0008N002, 154R0008N002U, 154R0008N003, 154R0008N005-154R0008N010, 154R0009N004, 154R0009N010, 154R0011N003, 154R0011N006-154R0011N009, 154R0012N001-154R0012N003, 154R0013N004, 154R0013N005, 154R0013N007-154R0013N010, 154R0014N009, 154R0016N001-154R0016N003, 154R0016N008, 154R0016N009, 154R0016N010, 154R0017N007, 154R0019N001-154R0019N005,  ...
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Class II RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. Radiometer America Inc
Drugs TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02 Lot 3C11 and 3C11A Class III Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets GlaxoSmithKline, LLC.
Food Raw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag. Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box. Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound case, bag in box. Item Number 11913, UPC Code: 172043119138 Lot 024413 Class I Positive laboratory result for Salmonella sp. Speciation in progress. Superior Nut Co. Inc.
Food US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs. Lot#T0010092, expiry date: September 2014 Class I Primex International Trading Corp. is recalling Pistachios Shelled, Halves, because it has the potential to be contaminated with Salmonella. Primex Intl Trading Corp
Drugs Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36 Lots: LF01643C, LF01644C, Exp 7/14 Class III Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card Sandoz Incorporated
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 #: CG2D18A, Exp 06/14 Class III Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits. Actavis Inc
Drugs Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4. Lot #: JX1877, Exp 06/13 Class II Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date. Apotex Inc
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