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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells W045005017417; W045005017418; W045005017426; W045005017430; W045005017437; W045005017438 Class III Blood products, with invalid HIV/HCV nucleic acid testing (NAT) results, were distributed. Community Blood Center of Greater Kansas City
Biologics Source Plasma 4714157; 4714753; 4715411 Class II Blood products, collected from a donor who previously tested positive for Hepatitis B surface antigen (HBsAg), were distributed. Mary Greeley Medical Center
Biologics Platelets Pheresis Leukocytes Reduced 11LG02923; 11LG03004, 11LG02926(P1); 11LG02926 (P2); 11LG02932(P1); 11LG02932(P2), 11LG02945; 11LG02949(P1), 11LG02949(P2); 11LG02951(P1); 11LG02951(P2), 11LG02953; 11LG02957(P1); 11LG02957(P2), 11LG02953, 11LG02960(P1), 11LG02960(P2); 11LG02965; 11LG02970(P1); 11LG02970(P2), 11LG03030(P1); 11LG03030(P2); 11LG03018(P1), 11LG03018(P2), 11LG03040(P1); 11LG03040(P2); 11LG03054; 11LG03013 11LG03034(P1); 11LG03034(P2), 11LG03074, 11LG03067(P1) 11LG03024; 11LG03013; 11LG03026; 11LG03074; 11LG03048; 11LG02980; 11LG02995; 11LG02999; 11LG02978; 11LG03057; 11LG03067(P2); 11LG03046; 11LG02932; 11LG03060; 11LG03062; 11LG03004, 11LG02975, Class II Blood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed. American Red Cross Blood Services
Biologics Source Plasma 06IMOA7790; 06IMOA7228; 06IMOA6898; 06IMOA6322; 06IMOA6048 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. BioLife Plasma Services LP
Biologics Red Blood Cells Leukocytes Reduced 006FS04297 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American National Red Cross, The
Biologics Source Plasma 6120145076, 6120137847, 6120137155, 6120136578, 6120135921, 6120134073, 6120133601, 6120131975, 6120131234, 6120130349, 6120129914, 6120129048, 6120128622, 6120127750, 6120127426, 6120126564, 6120126172, 6120125365, 6120124432, 6120123695, 6120123015, 6120122632, 6120121734, 6120121330, 6120120787, 6120119923, 6120119289, 6120118949, 6120118310, 6120117939, 6120117289, 6120116914, 6120116170, 6120115650, 6120114822, 6120114177, 6120113833, 6120113148, 6120112749, 6120112062 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. CSL Plasma, Inc
Biologics Red Blood Cells Leukocytes Reduced GH21702 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 4180273037,4180270764, 4180266853, 4180262108, 4180261397, 4180256862, 4180253172, 4180250494, 4180245124, 4180243722, 4180242872, 4180236288, 4180233903, 4180233565, 4180231839, 4180231448 Class II Blood products, collected from a donor who had not had an annual physical performed, were distributed. CSL Plasma, Inc
Biologics Source Plasma 4180253928, 4180250655, 4180245270, 4180242777, 4180242324, 4180229226, 4180224003, 4180210306 Class II Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed. CSL Plasma, Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated K47096 Class II Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced K47096 Class II Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma/Liquid Plasma 4240203191; 4240202188; 4240201501; 4240200163; 4240199668; 4240198041; 4240196915; 4240196219; 4240195380; 4240194609; 4240193795; 4240193268; 4240192176; 4240191692; 4240190721; 4240190268; 4240189306; 4240189065; 4240188195; 4240187586; 4240186387; 4240185611; 4240184951; 4240183873; 4240183517; 4240182263; 4240181724; 4240180641; 4240180206; 4240179162; 4240178951; 4240177911; 4240177729; 4240176805; 4240176099; 4240175018; 4240174624; 4240173554; 4240172999; 4240172073; 4240171396; 4240170548; 4240169885; 4240168756; 4240168208; 4240167150; 4240166625; 4240165560; 4240165043; 4240164097; 4240163516; 4240162425; 4240161746; 4240160819 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. Csl Plasma Inc
Biologics Source Plasma 4180282178, 4180279745, 4180278491, 4180277760, 4180276178, 4180275396, 4180273178, 4180272494, 4180270143, 4180266525, 4180265593, 4180264046, 4180263285, 4180261076, 4180260046, 4180258914. 4180257745, 4180256429, 4180254112, 4180252830, 4180252090 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. CSL Plasma, Inc
Biologics Source Plasma 4180295780, 4180294894, 4180293744, 4180283593, 4180282892, 4180281202, 4180280604, 4180278570, 4180277820, 4180276612, 4180274515, 4180263406, 4180260842, 4180260079, 4180256240, 4180253464, 4180249029, 4180247557, 4180246771, 4180244936, 4180242533, 4180239378, 4180238122, 4180234049, 4180232196, 4180230162, 4180228498, 4180201425, 4180199340, 4180196842, 4180195554, 4180194508, 4180192034, 4180189396, 4180188420, 4180187221, 4180186479, 4180185283, 4180184637, 4180183187, 4180182484 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. CSL Plasma, Inc
Biologics Source Plasma 6120184788, 6120182116, 6120180703, 6120180227, 6120179225, 6120178892, 6120177790, 6120177421, 6120176492, 6120175940, 6120171979, 6120170348, 6120169880, 6120168751, 6120168260, 6120167205, 6120166856, 6120165421, 6120164349, 6120164013, 6120162997, 6120162589, 6120161584, 6120161290, 6120160353, 6120155898, 6120154062, 6120152803, 6120152113, 6120151111, 6120150127. 6120149367, 6120148504, 6120147824, 6120147361, 6120146516, 6120139832, 6120139116, 6120137303, 6120136101, 6120134209, 6120133758, 6120133064, 6120131872, 6120131360, 6120130744, 6120139584, 6120129144, 6120128029, 6120127480, 6120126302, 6120125851, 6120125246, 6120124655, 6120124156, 6120123633, 6120123134, 6120122603, 6120121993, 6120121432, 6120120916, 6120119877 Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. CSL Plasma, Inc
Biologics Source Plasma 4180331755; 4180331283 Class II Blood products, collected from a donor who had not had an annual physical performed, were distributed. CSL Plasma, Inc
Biologics Source Plasma 6120191445 Class II Blood product, collected from a donor whose physical examination was incomplete, was distributed. CSL Plasma, Inc
Biologics Source Plasma 6120207155, 6120209576, 6120209315, 6120208409, 6120208457 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. CSL Plasma, Inc
Biologics Source Plasma 4180357508, 4180356223, 4180355586, 4180354295, 4180353710, 4180352509, 4180351968, 4180350287, 4180349041, 4180348511, 4180347274, 4180345499, 4180344657, 4180343823, 4180343000, 4180341053, 4180340360, 4180337642, 4180336133, 4180335468, 4180334421, 4180333841, 4180332742, 4180332015, 4180330994, 4180330361, 4180328295, 4180326367, 4180324587, 4180318627, 4180317614, 4180316239, 4180315098, 4180313340, 4180311686, 4180309998, 4180307699, 4180306098, 4180304902, 4180304275, 4180303246, 4180299690, 4180299081, 4180296193, 4180295467, 4180294037, 4180293389, 4180292056 Class II Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed. CSL Plasma, Inc
Biologics Source Plasma 4180290407, 4180287036, 4180284294, 4180281212, 4180280707, 4180277252, 4180272579, 4180268036, 4180265765, 4180264824, 4180263294, 4180262150, 4180261123, 4180260114, 4180258969, 4180257127, 4180256375, 4180254940, 4180254305 Class II Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed. CSL Plasma, Inc
Devices OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. HSC-056-32-1067051 Class II The tips of the drivers are breaking while being used to drive the screws into patients. Orthohelix Surgical Designs Inc
Devices OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. HSC-056-38-1067061 Class II The tips of the drivers are breaking while being used to drive the screws into patients. Orthohelix Surgical Designs Inc
Biologics Red Blood Cells Leukocytes Reduced 004KM20447; 004KM20488; 004KM20496; 004KM20520; 004KS42753; 004KM20450; 004KM20453; 004KS42776 Class II Blood products, collected from donors whose arm preparation was inadequate, were distributed. American National Red Cross (The)
Biologics Source Plasma 4140613225; 4140612523; 4140581482; 4140580782; 4140578837; 4140577908; 4140575951; 4140575036; 4140572923; 4140572023; 4140570304; 4140569645; 4140567576; 4140566265; 4140564698; 4140563245; 4140561679; 4140560376; 4140557425; 4140554999; 4140553972; 4140526449; 4140497533; 4140496378; 4140493098; 4140490859; 4140489881; 4140485193; 4140483573; 4140481484; 4140479914; 4140477740; 4140476696; 4140473287; 4140471125; 4140470089; 4140467939; 4140466345; 4140464890; 4140450547; 4140446540; 4140445479; 4140443871; 4140441426; 4140440699; 4140437662; 4140428864; 4140426883; 4140425978; 4140421489; 4140420581; 4140418186; 4140417609; 4140415423; 4140414696; 4140412624; 4140411954; 4140407551; 4140406574; 4140404641; 4140403233; 4140401772; 4140396726; 4140395141; 4140393701; 4140392195; 4140390838; 4140388946; 4140384411; 4140382992; 4140381378; 4140379502; 4140378027; 4140372101; 4140371139; 4140369324; 4140367440; 4140366542; 4140364365; 4140363574; 4140280861; 4140278756; 4140277773; 4140275407; 4140274524; 4140272672; 4140271809; 4140269889; 4140268100; 4140267275; 4140263303; 4140261905; 4140260453; 4140258970; 4140257679; 4140255588; 4140254264; 4140250919; 4140249596; 4140248130; 4140246765; 4140245406; 4140244065; 4140225325; 4140223493; 4140221844; 4140221072; 4140217378; 4140216493; 4140214814; 4140214030; 4140212214; 4140211478; 4140209774; 4140209001; 4140205337; 4140204469; 4140202914; 4140202111; 4140196246; 4140194848; 4140193691; 4140192470; 4140190797; 4140190016; 4140164810; 4140163986; 4140160621; 4140159164; 4140156438; 4140154970; 4140152719; 4140151909; 4140150500; 4140149432; 4140148224; 4140146839; 4140145321; 4140143399; 4140142605; 4140140678; 4140139919; 4140136502; 4140135390; 4140134026; 4140132464; 4140130969; 4140130258; 4140119613; 4140117241; 4140116168; 4140115037; 4140113992; 4140112986; 4140111846; 4140110755; 4140107327; 4140106209; 4140105241; 4140104023; 4140102679; 4140101997; 4140099247; 4140097860; 4140097129; 4140095718; 4140095099; 4140093901; 4140093053; 4140092135; 4140090007; 4140089126; 4140087789; 4140087212; 4140086061; 4140085472; 4140081408; 4140080632; 4140079501; 4140078702; 4140077848; 4140076758; 4140075734; 4140075023; 4140074324; 4140073742; 4140072670; 4140072092; 4140054330; 4140053881; 4140052807; 4140052261; 4140051221; 4140050170; 4140049582; 4140048233; 4140047761; 4140046724; 4140046278; 4140045354; 4140044856; 4140043873; 4140043449; 4140042171; 4140041556; 4140040598; 4140040076; 4140039174; 4140038586; 4140037748; 4140037331; 4140036303; 4140035806; 4140034671; 4140034195; 4140033318; 4140032865; 4140032049; 4140031663; 4140024779; 4140024261; 4140023308; 4140022789; 4140021629; 4140021160; 4140020324; 4140008740; Class II Blood products, collected from donors who were previously deferred for high risk behavior, were distributed. CSL Plasma, Inc.
Biologics Fresh Frozen Plasma W128709421812 Class II Blood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128709421812 Class II Blood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128710018949 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Delta Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W128710020715 (part I, part II) Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128711100317 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced Irradiated W128710142210 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128710142210 Class II Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128710142209 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Delta Blood Bank
Biologics FluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer Lot YL2077 Class III FluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed. MedImmune, LLC
Food Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl Batch 9429-1 Class III The product had the potential to contain foreign materials. Mothers' Milk Bank at Austin
Devices Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051. Class II Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass. Terumo Cardiovascular Systems Corporation
Devices Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373. Class II Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass. Terumo Cardiovascular Systems Corporation
Devices Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381. Class II Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass. Terumo Cardiovascular Systems Corporation
Biologics Platelets Pheresis Leukocytes Reduced W115112166840A; Class II Blood product, with platelet count below the specified minimum requirement, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Source Plasma 5080238043; 5080237145; 5080235642; 5080235128; 5080234049; 5080233479; 5080232406; 5080225818; 5080224961; 5080223129; 5080221982; 5080215743; 5080214633; 5080213587; Class II Blood products, collected from a donor whose physical examination was incomplete, were distributed. Octapharma Plasma, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W115912230409; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central California Blood Center
Biologics Blood and Blood Products for Reprocessing W115911273251; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115912230409; W115911273251; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038112074744; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 003GR02571; 003LC53425; Class II Blood products, collected from a donor who reported living in a malarial endemic area within the past three years, were distributed. The American National Red Cross - Southern Region
Biologics Source Plasma FP126179; FP125079; FP124605; FP124360; FP124182; FP123934; FP123311; FP122993; FP122782; FP122470; FP121845; FP121621; FP121096; FP120997; FP120475; FP120431; FP119845; FP119766; FP119762; Class II Blood products, collected from a donor who had been permanently deferred, were distributed. Interstate Blood Bank Inc. of Wisconsin
Biologics Red Blood Cells Leukocytes Reduced Irradiated W035412039602; W035412037992; Class III Blood products, labeled with extended expiration dates, were distributed. Community Blood Center
Biologics Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Sunquest Application Interfacing. The standard Department of Health Template (conception date of 2/9/2005). Class II Software, with a defect or glitch, was distributed. Sunquest Information Systems, Inc.
Drugs Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16. X111001, X111008, X111030, Exp 10/13 Class III Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. Actavis Mid Atlantic LLC
Drugs Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16 X110042, X110051, X110064, Exp 09/13 Class III Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. Actavis Mid Atlantic LLC
Devices Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital Emit(R) 2000 Phenobarbital Assay (OSR4D229), lots 1151, 1167, 1191, and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots D4, D5, D6, and D7 Class II Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be observed. Firm has observed a low frequency of outliers that differ from the expected value by 20%. Siemens Healthcare Diagnostics, Inc.
Biologics Product is a 50% glycerinated Aspergillus niger (Human) Allergenic Extract in liquid form. Product is vialed in 10 mL type 1 glass vials,stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap. Lot Number: 200795 Class II Mislabeled vials of Allergenic Extract were distributed. Greer Laboratories Inc
Devices IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps® ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps® ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies Lot 14541, EXP Nov 2012 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease. Lot 1184, EXP Aug 2012 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser. Lot 1177, EXP Aug 2012 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid® Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis. Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid® Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid® Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser. Lot 958, EXP Sep 2012 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser. Lot 1170, EXP Feb 2013 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Devices IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser. Lot 975, EXP Sep 2012 Class II It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage. Immunodiagnostics Systems Ltd
Biologics Associates of Cape Cod Pyrotell Limulus Amebocyte Lysate (LAL) . In vitro diagnostic use to detect and quantify endotoxin gel-clot method Catalog Number: G5250-5: 5 vial Packs; Catalog Number: G5250-25: 25 vial Packs Lot number: 51006539 Class III One lot of mislabeled Pyrotell gel clot LAL reagent was distributed. Associates of Cape Cod, Inc.
Food Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The UPC is 0 34199 718903; USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12 Class II Soy was partially declared on the label because the ingredient list is cut off at the right side of the label. Pacific Northwest Tofu, LLC
Food Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Hot & Spicy Tofu has the UPC 0 34199 719191. USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12 Class II Wheat or Sesame Seed Oil was partially declared on the label because the ingredient list is cut off at the right side of the label. Pacific Northwest Tofu, LLC
Food Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The Teriyaki Tofu has the UPC 0 34199 718965. USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12 Class II Soy was partially declared on the label because the ingredient list is cut off at the right side of the label. Pacific Northwest Tofu, LLC
Food Stir Fried Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Stir Fried Tofu has the UPC 0 31499 003283. USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12 Class II Soy was partially declared on the label because the ingredient list is cut off at the right side of the label. Pacific Northwest Tofu, LLC
Food Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case. Product labeling reads in part:" NEERA'S TIKKA CURRY Rich and Creamy All Natural Simmering Sauce***Just add meat, fish or vegetables!***16 Fluid Ounces / 473 mL***Manufactured by Cinnabar Specialty Foods, Inc. Prescott, AZ 86305 866 293 6433 www.cinnabarfoods.com***". UPC: 7-3778516002-4 EXPIRATION NUMBERS: 09/06/12, 11/28/12, 02/07/13, 04/26/13 and 05/05/13 Class II The product was recalled due to undeclared sub-ingredients of milk and soy. Cinnabar Specialty Foods Inc
Food Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl. Batch # 8638-1 Class II The product had the potential to contain foreign materials. Mothers' Milk Bank at Austin
Food Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22, Protein: 1.0 g/dl. Batch # 78501-1 Class II The product had the potential to contain foreign materials. Mothers' Milk Bank at Austin
Devices PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. Serial numbers AS180-00001 to AS180-00376. Class II The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. Biomerieux Inc
Biologics MicroCel 500 Buffer Chamber Mfg by: Siemens Healthcare Diagnostics Inc., Berkeley, CA. Catalog number 10312319/VG 42115 Product will have the letter R after the manufacture date. Class II Trugene MicroCel 500 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed. Siemens Healthcare Diagnostics Inc.
Devices Siemens syngo.plaza radiological image processing system. Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146. Class II Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing. Siemens Medical Solutions USA, Inc
Devices Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. product code 2C7519, all lots Class I Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. Baxter Healthcare Corp.
Devices Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. product code 2H7519, all lots Class I Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. Baxter Healthcare Corp.
Devices Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. product code 2C8819, all lots Class I Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. Baxter Healthcare Corp.
Devices Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. product code 2H8819, all lots Class I Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. Baxter Healthcare Corp.
Devices Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement. NAC-1820M, Lot number: 121003 Class II Sterility of the product may be compromised. Remington Medical Inc.
Biologics Capture-R Ready Indicator Red Cells Lot 221861, Exp. 2012-09-06 Class II Single lot of Capture-R Ready Indicator Red Cells, which may result in higher rates for equivocal and unexpected positive reactions compared to other in-date or previously released lots, was distributed. Immucor Inc
Food SooNyeoWon Soybean Sprouts (5 lbs., 10 lbs., and 16-ounce packages - all packaged in plastic bags). 16-oz bag UPC 0 28346 07121 8; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 Unknown Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food SooNyeoWon and Jinga brand Firm Tofu; Net Wt. 16 oz., in square white plastic container, UPC 0 28346 07812 5 and 0 28346 09112 4, respectively. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 Exp date 9/8/2012 or later Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food Soy Milk, 1.3 gallon, packaged in a white plastic pail, UPC 0 28346 07140 9. Produced by Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105. Unknown Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food SooNyeoWon Healthy Soybean Sprouts, 16 ounce package; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 On or after July 18, 2012 Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food SooNyeoWon and Jinga brand Soft Tofu 16 oz. in square, plastic containers, UPC 0 28346 07814 9 (SooNyeoWon). Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 9/8/2012 or later Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food SooNyeoWon Silken Tofu; 14 oz. plastic container, UPC 0 28346 09113 1. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 9/8/2012 or later Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food Labeled in Korean as Healthy Tofu, 5-pieces and 10 pieces, UPC 028346091292. Manna Organics Inc. Newark, NJ. 7/25/2012 or later Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Food Soon Tofu, 30-pieces packaged in large, white, plastic bucket. Manna Organics Inc. Newark, NJ 7/24/2012 or later Class I Products have the potential to be contaminated with Listeria monocytogenes. Manna Organics Inc
Devices Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 9490; and lot numbers: 0101,1001-1025,1188-1192,1997, 2000-2017, 2019- 2082, 2086-2287, 2290-2446, 2452-2633, 2636-2938, and 2946-3063 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient. Terumo Cardiovascular Systems Corporation
Devices Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient. Terumo Cardiovascular Systems Corporation
Devices Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair Model Number 5361 Class II Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly. Winco Mfg., LLC
Devices Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair Model Number 5351 Class II Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly. Winco Mfg., LLC
Food Pico De Gallo in a plastic container labeled: "Pineapple/Mango Pico De Gallo Roma Tomato, Pineapple, Mango, Red Onion, Green Bell Pepper, Anaheim Pepper, Cilantro Lime Juice, jalapeno Pepper, Salt 88694 83987 Keep Refrigerated Best used by: 09/10/12 Packed by Spokane Produce, Inc 1905 S Geiger Blvd Spokane, WA 16 oz (454g)" "Best used by: 09/10/12" Class I Daniella brand mangoes recalled because they may be contaminated with Salmonella. Mangoes were used to manufacture Pico De Gallo. Spokane Produce, Inc.
Food florAlign Prebiotic Formula, sizes: 90g, 180g, 270g UPC code #'s FA02-90GM, FA02-180GM, and FA02-270GM Class I Eco Health is recalling florAlign Prebiotic Formula because it has the potential to be contaminated with Salmonella. Eco Health, Inc.
Devices TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile. Lot No. 062711. Expiry date is June 2014. Class II The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. Kardium
Devices Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use. Lot # 110919D, 111017C, 111017D, 111114C, 111212C. Class II The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%. Beckman Coulter Inc.
Food Marte brand Frescolina Ricotta Salata. Matured and packed by: Fattorie Chiarappa SRL VIA Dell'ulvio, 5 Conversano (BA) - Italy. --- Product is vacuum packaged and is labeled with a round label. Product may also be cut into smaller wedges, but will still have the same Frescolina Ricotta Salata label. all lots and all production codes. Includes T5086/440220, T5520/440315, T6048/440417, T6528/440519, T7012/440703, T7452/440601, T7939/440822, T8419/441003, T8899/441020, T9425/441202, T9962/441227, U1392/450126 Class I Frescolina brand Ricotta Salata cheeses found positive for Listeria Monocytogenes resulting from CA state and FDA sampling. Forever Cheese Inc
Devices The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini - 3788 (IPG), Multiple Serial Numbers Class II Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board. Advanced Neuromodulation Systems Inc.
Devices ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used. All lots except those starting with SY Class II Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. Medtronic Sofamor Danek USA Inc
Devices ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used. All lots except those starting with SY Class II Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. Medtronic Sofamor Danek USA Inc
Devices PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used. All lots except those starting with SY Class II Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length. Medtronic Sofamor Danek USA Inc
Devices Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). all serial numbers Class II Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results. Beckman Coulter Inc.
Devices CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. All tetraCHROME lots manufactured Class II The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results. Beckman Coulter Inc.
Devices CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. All tetraCHROME lots manufactured Class II The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results. Beckman Coulter Inc.
Devices TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. All tetraCHROME lots manufactured Class II The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results. Beckman Coulter Inc.
Food Organic Pine Nuts (Raw, No Shell) 1 lb.Nuts.com NutsOnline, 125 Moen Street, Cranford, NJ 07016 800-558-8881 Lot 97368 Class I Pine nuts may contain peanuts Newark Nut Stores, Inc.
Food Color Cheddar Cheese Curds: Springside Cheese, Color Curd, 55-0172, V1, August 27, 2012, 8.21.1 8.22.1 8.24.1 8.24.2 8.24.3 8.25.1 8.25.2 8.25.3 8.27.1 8.27.2 8.28.1 8.28.2 8.29.1 8.29.2 8.31.1 8.31.2 9.1.1 9.1.2 9.1.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Color Cheddar, 55-0172, V1, August 21, 2012, 8.22.1 8.25.3 8.31.2 9.1.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Black Pepper Color Cheddar, 55-0172, V2, August 24, 2012, 8.24.2 8.27.2 9.1.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Blue Cheese Color Cheddar, 55-0172, V2, August 24, 2012, 8.24.2 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Color Cheddar Horseradish Cheese, 55-0172, V2, August 24, 2012, 8.24.2 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Color Cheddar Tomato Basil , 55-0172, V1, August 21, 2012, 8.21.1 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Caribbean Red Hot , 55-0172, V3, August 28, 2012, 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Chipotle Cheese, 55-0172, V3, August 21, 2012. 8.21.3 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Cranberry Monterey Jack Cheese, 55-0172, V3, August 28, 2012, 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Dill Cheese, 55-0172, V3, August 21, 2012, 8.21.3 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Habanero Cheese, 55-0172, V3, August 21, 2012, 8.21.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Jalapeno Cheese, 55-0172, V3, August 21, 2012, 8.21.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food White Cheddar Cheese Curds: Springside Cheese, White Curds, 55-0172, V2, August 22, 2012, NET WEIGHT___. 8.22.2 8.22.4 8.29.3 8.29.4 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Maple White Cheddar, 55-0172, V3, August 22, 2012. 8.22.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Black & Green Olive White Cheddar Midget, 55-0172, V3, August 22, 2012. 8.22.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Reduced Fat Farmers Cheese, 55-0172, V2, August 21, 2012. 8.21.2 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Reduced Fat Caraway Farmers, 55-0172, V2, August 21, 2012. 8.21.2 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Colby Cheese, 55-0172, V3, August 27, 2012. 8.27.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Bacon Colby Cheese, 55-0172, V3, August 27, 2012. 8.27.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Morel & Leek Monterey Jack, 55-0172, V3, August 28, 2012. 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Peppercorn Ranch , 55-0172, V3, August 28, 2012. 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Roasted Red Pepper Cheese, 55-0172, V3, August 28, 2012. 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, Monterey Jack Salsa Cheese, 55-0172, V3, August 28, 2012. 8.28.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Food Springside Cheese, rBGH Free White Cheddar, 55-0172, V32 August 22, 2012. 8.22.3 8.29.3 Class II Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness. Springside Cheese Corp
Devices Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems. Lot# 112788, 115741, 118917 Class II Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. Beckman Coulter Inc.
Devices Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems Lot# 122651, 123635, 219962 Class II Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. Beckman Coulter Inc.
Devices Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142. Class I Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. Accutron Inc
Devices Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739, 13743, 13746, 13750, 13751, 13753, 13754, 13755, 13756, 13760, 13762, 13766, 13774, 13775, 13777, 13781, 13782, 13783, 13785, 13786, 13788, 13792, 13794, 13796, 13799, 13800, 13803, 13804, 13809, 13810, 28298, 28299, 28304, 28305, 28306, 28307, Ultra PC% Cabinet Mount Pkg I, Model #36800, Serial # 13601, 13603, 13607, 13608, 13609, 13613, 13618, 13620, 13623, 13626, 13629, 13630, 13631, 13632, 13641, 13645, 13646, 13648, 13649, 13651, 13652, 13653, 13654, 13655, 13656, 13657, 13658, 13659, 13660, 13661, 13665, 13666, 13667, 13668, 13671, 13672, 13674, 13676, 13677, 13684, 13688, 13689, 13698, 13700, 13707, 13723, 13727, 13730, 13732, 13734, 13741, 13742, 13757, 13758, 13759, 13761, 13762, 13763, 13764, 13765, 13767, 13769, 13789, 13790, 13791, 13795, 13797, 13801, 13802, 13806, 13808, 28300, 28302, 28303, Ultra PC% Cabinet Mount Pkg G, Model#36600-NS, Serial# 13805, 13807, 13811, 13812. Ultra PC% Cabinet Mount Pkg H, Model#36800-NS, Serial# 13744, 13745,13752, 13773, 13774, 13778, 13779, 13780 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Model #36600, Lot # 73778, 73740, 73851, 73920, 74475, 74035, 74012, 74219, 74118, 74471, 75583, 74372, 75049, 74745, 75049, 75283, 75616, 75299, 74926, 75767, 75344, 75311, 74513. Model #36800, Lot# 73739, 73852, 74011, 73921, 74470, 74032, 74011, 73969, 74139, 74125, 74204, 74220, 74143, 74617, 74573, 74746, 75584, 75449, 74927, 75617, 74568 Model#36600-NS, Lot#75328. Model#36800-NS, Lot#75286. Class I Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. Accutron Inc
Devices CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Lot # 75285 Class I Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. Accutron Inc
Devices Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine. Lot # 73656, 74139, 75209, 74689, 75515, 74858. Class I Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. Accutron Inc
Devices Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. Lot Numbers: W42932B W42933B W42934B W42935B W43279B W43281B W43282B W43283B W43284B W43285B W43286B W43287B W43288B W43637B W43638B W43640B W43646B W43648B W43649B W43650B W43652B W43653B W43655B W43657B W43659B W43660B W43661B W43663B W43664B W43665B W43692B W43693B W43694B W43695B W43696B W43697B W43698B W43699B W43700B W43701B W43702B W43703B W43704B W43705B W43706B W43707B W43708B W43709B W43710B W43711B W43712B W43713B W43714B W43715B W43716B W43717B W43718B W43983B W43984B W43985B W43986B W43987B W43988B W43989B W43990B W43991B W43992B W43993B W43994B W43995B W43996B W43997B W43998B W43999B W44000B W44001B W44002B W44003B W44004B W44005B W44006B W44007B W44008B W44009B W44010B W44011B W44012B W44013B W44014B W44015B W44016B W44017B W44018B W44019B W44020B W44021B W44022B W44023B W44024B W44025B W44026B W44027B W44028B W44029B W44030B W44031B W44032B W44033B W44034B W44036B W44037B W44038B W44039B W44040B W44041B W44042B W44043B W44044B W44045B W44046B W44047B W44048B W44049B W44050B W44051B W44052B W44053B W44054B W44055B W44056B W44057B W44058B W44059B W44060B W44061B W44062B W44063B W44064B W44065B W44066B W44067B W44068B W44246B W44269B W44628B W44665B W44666B W44667B W44668B W44669B W44670B W44671B W44672B W44673B W44675B W44676B W44677B W44678B W44679B W44680B W44681B W44682B W44683B W44684B W44686B W44687B W44688B W44690B W44692B W44693B W44697B W44698B W44699B W44700B W44703B W44704B W44708B W44709B W44710B W44712B W44713B W44715B W44716B W44717B W44718B W44719B W44723B W44988B Class II Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. Alere San Diego, Inc.
Food Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs) Product has no lot numbers. Product date: 15-11-2011. Class III Chang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic. Chang Jiang Seafood Ca Inc
Food Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4 E18911 Best by: 07-08-2013 E19311 Best by: 07-12-2013 E31311 Best by: 11-09-2013 E31411 Best by: 11-10-2013 E03212 Best by: 02-01-2014 E03812 Best by: 02-07-2014 Class II Da Vinci Pesto Genovese with Basil and Pine Nuts 10 oz. is mislabeled as the front of the label indicates pine nuts which was inadvertently omitted from the ingredient statement. World Finer Foods, Inc.
Food Marathon brand- 4 kilo boxes, label on the mango says "MARATHON...PRODUCE OF MEXICO", 952 ctns. of number 6 mangos, 714 ctns. of number 7's, 1186 ctns. of number 8's, 952 ctns. of number 9's, 714 ctns. of number 10's, 476 ctns. of number 12's. DH80 is lot code of recalling firm Class I GM Produce Sales is voluntarily recalling 4994 cartons of Marathon Brand mangos packed at Agricola Daniella, in Los Mochis, Sinaloa, because it has the potential to be contaminated with Salmonella gaminara, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. GM Distributing Co, Inc
Food diet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979 Lot Codes: AUG 27 12 NT05242, SEP 17 12 NY06142, OCT 01 12 NT06252, and OCT 22 12 NY07272. Class II Diet Orange Soda contains undeclared high fructose corn syrup. Pepsi Bottling Group Nashville
Food Fruit Medley - 1) Zupan's brand Island Medley 12 oz UPC 92504723497 2) Mary's Select brand Island Fruit Medley - 12 oz UPC 9250473497 3) Mary's Select brand Fruit Mix Ensalada - 12 oz UPC 9250473216 4) Trader Joe's Plant Code: P-002 brand - Tropical Fruit Medley - 1 lb UPC 0094-9361 1) Best if Sold By 09/02/12 - 09/17/12 2) Best if Sold By 09/02/12 - 09/17/12 3) Best if Sold By 09/02/12 - 09/17/12 4) Best By: 09/02/12 - 09/18/12 Class I The mangos used to manufacturer the products may be contaminated with Salmonella. United Salad Company
Food Fruit Mango diced, peeled halves or spears 1) United Salad Co. brand Mango Diced 5 lb no UPC 2) United Salad Co brand Mango Peeled Halves 1 lb not UPC 3) Garden Highway Plant Code: P-002 Mango Spears 24 oz UPC 826766-214068 1) Packed on 8/28/12- 9/7/12 2) Packed on 8/28/12 - 9/7/12 3) Best if Sold By: 09/02/12 - 9/17/12 Class I The mangos used to manufacturer the products may be contaminated with Salmonella. United Salad Company
Food Mango Salsa 1) Garden Highway Plant Code: P-002 brand Mango Salsa 9 oz UPC 826766-422005 2) Mary's Select brand Tropical Salsa 16 oz UPC 9250474578 3) Mary's Select brand Tropical Salsa 16 oz UPC 9250474569 4) Garden Highway Plant Code: P-002 brand Salsa Tropical Fresh 11 oz UPC 826766-422104 1) Best if Sold By: 09/02/12 - 09/17/12 2) Best if Sold By: 09/02/12 - 09/17/12 3) Best if Sold By: 09/02/12 - 09/17/12 4) Best if Sold By: 09/02/12 - 09/17/12 Class I The mangos used to manufacturer the products may be contaminated with Salmonella. United Salad Company
Food CANTALOUPE, HONEY DEW, PINEAPPLE AND GRAPES (CHPG) UNDER THE FOLLOWING BRANDS: Indianhead Foods 13105 FRUIT MIX CHPG 5# Manufactured by Cut Fruit Express Mpls, MN 55076 Following products Distributed by H. Brooks & Co. Mpls, MN 55112: H.Brooks & Company 31165 MIXED FRUIT CHPG 4/16OZ 16oz 4 per case UPC# 0 3823231165 6. Festival Foods-Best Of The Season 31165 MIXED FRUIT CHPG 4/16OZ 16oz 4 per case UPC# 0 3823231165 6. Kitchen Cravings Kwik Trip #1 31595 FRUIT CUP MIX Chunks 5.5oz 24 per case UPC# 0 3977955262 5. Kitchen Cravings Kwik Trip #31616 Fruit Tray 16 oz 12 per case UPC#0 3977955265 6. Supermom's /Super America-Goodies-to go! 31595 FRUIT MIX CHPG 5.5 oz 24 per case UPC# 76391390250 1. H.Brooks 34382 MIXED FRUIT CHPG Net Wt 8 oz(227g) 6 per case 19 UPC# 0 3823234382 4. H.Brooks 37663 FRUIT MIXED CHPG Net Wt 12oz(340g) 4 per case 175 UPC# 0 3823237663 1. Use by 9/11 - 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE: UPPER LAKES Foods 142901 CANTALOUPE CHUNK 2/3# UPPER LAKES Foods 142800 CANTALOUPE HALVED/PEELED 2/5# & 5# USF 4259982 CANTALOUPE DICED 1/2" X 1/2" 2/5# CCP USF 4384418 CANTALOUPE CHUNKS 25# USF 8138646 CANTALOUPE CHUNK 4/5# USF 5985015 CANTALOUPE CHUNK 5# USF 0900001 CANTALOUPE PLD & HALVED 10# Manufactured by Cut Fruit Express, Mpls MN 55076. The following products Distributed by H Brooks & Co Mpls MN 55112: H.Brooks 37575 CANTALOUPE CHUNK Net WT 16 oz (454g) 4 per case 57 UPC# 03823237575 7. H.Brooks 33326 CANTALOUPE CHUNK 5# Net Wt 80 oz (2268g) 1 per case 02 UPC# 0383233326 9. Festival Foods-Best Of The Season H.Brooks 33326 CANTALOUPE CHUNK 5# Net Wt 80 oz (2268g) 1 per case 02 UPC# 0383233326 9. H.Brooks 31931 CANTALOUPE FRUIT CUP 6/5.5 Net Wt 5.5oz(16g) 6 per case 164 UPC# 03823231931 7. Festival Foods-Best of the Season 31931 H.Brooks 31931 CANTALOUPE FRUIT CUP 6/5.5 Net Wt 5.5oz(16g) 6 per case 164 UPC# 03823231931 7. H.Brooks 37567 CANTALOUPE CHUNK 4/12OZ Net Wt 12oz(340g) 4 per case 46 UPC# 0 3823237567 2. H.Brooks 26868 CANTALOUPE SLICES Net Wt 10 oz (284g) 3 per case 214 UPC# 0 3823226868 4. Reinhart Marshall 32774 CANTALOUPE DICE 40/1/2Cup Net Wt 3 oz (85g) 40 per case 360 CCP. Holiday Pantry 31561 Cantaloupe Chunks Net Wt 5.5oz (156g) 24 per case 309 UPC# 0 3823231561 6. Kitchens Cravings Cantaloupe Kwik Trip 31561 CANTALOUPE Chunks 5.5oz 24 per case UPC# 03977955259 5. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, HONEY DEW, GRAPES (CHG) UNDER THE FOLLOWING BRANDS: USF 0811125 FRUIT MIX CHG RECEPTION 25# Manufactured by Cut Fruit Express Mpls., MN 55076. The following products Distributed By H. Brooks & Co. Mpls MN 55112: Festival Best of the Season Medley Fruit Cup H.Brooks 31907 Net Wt 5.5 oz. (156g) 6 units per case 158 UPC# 0 3823231907 2. H.Brooks 31907 Medley Fruit Cup Net Wt 5.5 oz. (156g) 6 units per case 158 UPC# 0 3823231907 2. Holiday Pantry 32096 Fruit Medley Mix Net Wt 5.5 OZ (1256G) 24 units per case UPC# 0 3823232096 2. H.Brooks 37647 MIXED FRUIT CHG Net Wt 12oz( 340g) 4 per case 173 UPC# 0 3823237647 1. Festival Foods-Best Of The Season H. Brooks 37655 MIXED FRUIT CHG Net Wt 16oz(454g) 4 per case 174 UPC# 0 3823237655 6. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, WATERMELON, HONEY DEW, RED GRAPES: Festival Foods-Best Of The Season 30787 H.Brooks Melon Mix Slices Net Wt. 12 oz. (340g) 3 units per case 331 UPC# 0 3823230787 1. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, HONEYDEW, GRAPE, PINEAPPLE, STRAWBERRY: Festival Foods-Best Of The Season 32299 H. Brooks FRUIT BOWL CHPGS 3# Net Wt 48 oz (1362g) K280 2 per case UPC# 0 3823232299 7. Distributed by H.Brooks & Co Mpls MN 55112 Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, HONEYDEW, PINEAPPLE AND RED GRAPE, DIP: H.Brooks 33478 FRUIT TRAY w/dip 2.5# Net Wt 40 oz (1134 g) 292 2 per case UPC# 0 3823233478 5. H.Brooks 38279 FRUIT TRAY w/Dip 3# Net Wt 48 oz (1361g) 2 per case 101 UPC# 03823238279 3. H.Brooks 38287 FRUIT TRAY w/Dip 2# DIP Net Wt 32 oz (907g) 4 per case 17 UPC# 0 3823238287 8. Distributed By H. Brooks & Co. Mpls MN 55112 Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, PINEAPPLE AND WATERMELON: H.Brooks & Company 33531 FRUIT MIX CPW SPEARS 15oz (425g) 4 per case UPC# 0 3823233531 7. Distributed by H. Brooks & Co Mpls. MN55112. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, HONEYDEW: Festival Foods-Best Of The Season 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. H.Brooks 46981 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. Distributed by H. Brooks & Co. Mpls. MN 55112. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Food CANTALOUPE, HONEYDEW, WATERMELON: Festival Foods-Best Of The Season 37461 H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3. H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3.. Distributed by H. Brooks & Co. Mpls. MN 55112. Use-by 9/11 to 9/14 Class I Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample. Cut Fruit Express, Inc.
Devices Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. All units of these models. Class II Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description. Optovue Inc.
Devices 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only. Model 5XL 1-door, serial numbers from 721799 - 722166. Model 5XL 2-door, serial numbers from 820248 - 820285. Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105 Class II 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim. 3M Company - Health Care Business
Food FRESH SELECTIONS by Kroger" Tender Spinach NET WT 10 OZ (283g) BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 INGREDIENTS: SPINACH DISTRIBUTED BY THE KROGER COM. CINCINNATI OHIO 45202 BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 Class I The firm was notified by the Ohio Department of Agriculture of positive Listeria Monocytogenes in their Fresh Selection Tender Spinach. Kroger Co
Food Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc. Item #79003, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Charl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc. Item #79009, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Crab Stuffing  Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc. Item #79011, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food HT Signature Lump Crab Cake (Fresh), #81791, 4 oz @ 2x8ct, Net wt. 4 lbs, Packed by 3fish, Inc. Item #79018, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Carolina Style Crab Cakes (Frozen), 2 x 8ct  INGLES, Net Wt 4 lbs, Packed by 3fish, Inc. Item #79035, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Frozen Crab Bites, ½ oz, Bulk 100 x 0.5oz, Net Wt: 50 oz, Packed by 3fish, Inc. Item #79037, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food MD Crab Cakes - Value Tray Pack (Frozen), 6  4x3oz, Customer Item: 504583, Packed by 3fish, Inc. Item #79048, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Harris Teeter, Atlantic Stuffed Salmon 8ct (Fresh) Item #79202, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Harris Teeter, Stuffed Tilapia 8ct (Fresh) Item #79203, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Harris Teeter, Stuffed Flounder 8ct (Fresh). Item #79204, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food HT Premium Lobster Cake (fresh), 3 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc. Item #79420, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Jalapeno Salmon Cake 3oz (Fresh), 4 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc. Item #79103, Lot #22YAW1A1235 (Diced Yellow Onions) Class I Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination. 3fish Inc.
Food Fresh Express Leafy Green Romaine; Crunchy Romaine Lettuce & Tender Green Leaf Lettuce 9 oz. bag, Keep refrigerated, no preservatives. UPC 71279-26112. Fresh Express Incorporated Salinas, CA. Code: I246A5BMG, Use-By-Date: September 16, 2012. Class I USDA MDP program had a positive sample result for Listeria Monocytogenes. Fresh Express Incorporated
Food Cut Cantaloupe: G.O Fresh: 0379729 4/5# CANTALOUPE CHUNKS (PACKER) 130250 BEST BY 9/16/12. SYSCO Imperial: 2229268 4/5# MELON CANTALOUPE 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865593455. SYSCO Imperial: 6520878 1/5# PAIL CANTALOUPE CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865393345. SYSCO Imperial 8628554 1/5# CANTALOUPE DICE 1/2" HC 130250 BEST BY 09/16/12, UPC # 0007 4865537049. SYSCO Imperial O325852 1/10# CANTALOUPE W/P & HALVED 130249 & 130250, BEST BY 9/15/12 & 9/16/12, UPC# 0007 4865941983. SYSCO Imperial O325852 1/10# WHOLE/HALVED BEST BY 9/15/12 & 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food Mixed Fruit w/ Grapes: SYSCO Imperial 1210321 4/5# FRUIT MIX CHUNK W/GRAPES 130250 BEST BY 9/16/12. SYSCO Imperial 2665156 4/5# MIX MELON W/ REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865599914. SYSCO Imperial 3278165 1/5# FRUIT MIX CHUNK WI/GRAPE 130249 & 130250, BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865618960. BEST BY 9/15/12 & 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 2232734 4/5# FRUIT VARIETY CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865593493. BEST BY 9/15/12 & 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 47340104/5# FRUIT MIX W/ORANGE WEDGES 130250 BEST BY 9/16/12, UPC# 0007 4865498029. BEST BY 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 4835718 30/4.5 OZ FRUIT MIX CANT/PINE/REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12. SYSCO Imperial 7068657 4/5# FRUIT MIX CANT/PINE/RED GRAPE 130250 BEST BY 9/16/12. BEST BY 9/15/12 & 9/16/12. Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 6520795 1/5# FRUIT MIX CHUNKS 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865393314. BEST BY 9/15/12 & 9/16/12, Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 5370204 30/4.5 OZ/ ,30# FRUIT VARIETY GARDEN-TO-GO 130249 & 130250 BEST BY 9/15/12 & 9/16/12 . BEST BY 9/15/12 & 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 9498072 FRUIT W/GOLD PINEAPPLE KIT 4/1.5# 130250 BEST BY 9/16/12, UPC# 1007 4865871287. BEST BY 9/16/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Food SYSCO Imperial 1/5# PAIL MELON MIX HONEY-CANT W/ GRAPE 7225071 1/5#MELON W/GRAPE 130249 BEST BY 9/15/12, UPC# 0007 4865448475. BEST BY 9/15/12 Class I G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination. G.O. Fresh
Drugs Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 , 2012028142 exp. 1/2014 Class II Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval. Paddock Laboratories, LLC
Devices 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system. Part Number (Item #) AG8049-NS, Lot # 2528655. Class II ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set. ICU Medical, Inc.
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