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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced KN07221 Part A ;KN07221 Part B ;KN07221 Part C Class II Blood products, for which the quality control testing was incomplete or not performed , were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 05LWYC0246; 05LWYC0547; 05LWYC1310; 05LWYC1732; 05LWYC2154 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 08OUTB1976, 08OUTB1529, 08OUTB0961, 08OUTB0273, 08OUTBA9103, 08OUTA8564, 08OUTA7926, 08OUTA6759, 08OUTA6248, 08OUTA5650, 08OUTA5118, 08OUTA4464 Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 08OUTB2306 Class II Blood product, for which the sterility may have been compromised during collection, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 55F16132 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 55F16132 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed American National Red Cross (The)
Biologics Source Plasma 08OUTD6551, 08OUTD4301, 08OUTD3924, 08OUTD1660, 08OUTD1174, 08OUTD0586, 08OUTC5971, 08OUTC5400, 08OUTC4692, 08OUTC4317, 08OUTC3409, 08OUTC2970, 08OUTC2325, 08OUTC1695, 08OUTC1093, 08OUTC0373, 08OUTB9920, 08OUTB9060, 08OUTD5251, 08OUTD5616, , 08OUTD7075, 08OUTD7926, 08OUTD8806, 08OUTD9079, 08OUTE3717, 08OUTE4270, 08OUTE6072, 08OUTE8200, 08OUTE7490, 08OUTE6713, 08OUTE5972, 08OUTE5530, 08OUTE8484, 08OUTE5464, 08OUTE4979, 08OUTE3618, 08OUTE2621, 08OUTE2221, 08OUTE1511, 08OUTE0774, 08OUTE0325, 07OUTE6189, 07OUTE5921, 07OUTE5428, 07OUTE4998, 07OUTE4173, 07OUTE3749, 07OUTE2920, 07OUTE2343, 07OUTE7637, Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 366094388, 366093087, 366092413, 366091596, 366084072, 366083393, 366082163, 366065026, 366060955, 366113926, 366110996, 366110471, 366109901, 366108842, 366107910, 366107049, 366106353, 366105442, 366105014, 366102656, 366101856, 366101112, 366100324, 366099605, 366098399, 366097660, 366096836, 366096068, 366095287, 366094510, 366093322, 366092563, 366091863, 366082317, 366081714, 366080489, 366079137, 366075995, 366093105, 366070315, 366069379, 366068747, 366068434, 366067647, 366067277, 366066211, 366065866, 366064670, 366064344, 366063599,  ...
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Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed Talecris Plasma Resources, Inc.
Biologics Source Plasma 0341007549 0341005122 0341004679 0341002609 0341002159 0341000629 0340999968 0340997686 0340996842 0340996406 0340995527 0340994628 0340994019 0340993267 0340992600 0340991873 0340990962 0340989961 0340989647 0340988469 0340987833 0340986753 0340983456 0340981203 0340978612 0340977603 0340976941 0340975620 0340975208 0340974094 0340973742 0340972294 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 4210323584; 4210304150; 4210303303; 4210297992; 4210293731; 4210291514; 4210289430; 4210288836; 4210285683; 4210283789; 4210281923; 4210279978; 4210279178; 4210276807; 4210271979; 4210271352; 4210263791; 4210262764; 4210259138; 4210256999; 4210255306; 4210254855; 4210252067; 4210250138; 4210248709; 4210247652; 4210245956; 4210244829; 4210243609; 4210242768; 4210228374; 4210227747; 4210225801; 4210224285; 4210222290; 4210220217; 4210218485; 4210217989; 4210216569; 4210215918; 4210214293; 4210209079; 4210208585. Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.. CSL Plasma, Inc.
Biologics Source Plasma 4100356139; 4100352050; 4100349660; 4100348615; 4100347189; 4100344881; 4100343098; 4100341929; 4100340798; 4100339619; 4100337254; 4100335779; 4100334476; 4100333203; 4100332004; 4100330362; 4100329365; 4100327908; 4100327047; 4100325518; 4100324794; 4100322468; 4100319907; 4100309110; 4100306283; 4100299035; 4100269941; 4100261168; 4100258592; 4100255865; 4100253193; 4100250678; 4100249217; 4100248010; 4100244455; 4100241666; 4100204861; 4100203016; 4100201527. Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 0340915828, 0340915071, 0340914770, 0340913746, 0340912654, 0340911284, 0340911018, 0340910027, 0340909550, 0340908516, 0340907958, 0340907400, 0340906861, 0340906361, 0340905737, 0340904779, 0340904365, 0340903388, 0340902528, 0340901517, 0340900743, 0340900331, 0340899543, 0340899046, 0340898242, 0340897871, 0340896285, 0340895930, 0340894987, 0340894700, 0340893917, 0340893580, 0340892772, 0340892465, 0340891581, 0340890613, 0340889733, 0340885348, 0340884896, 0340884156, 0340883695, 0340883041, 0340882530, 0340881146, 0340880335, 0340878822,  ...
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Class II Blood products, collected from donors who were previously deferred, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 4100277850; 4100276582; 4100275333; 4100274081; 4100272722; 4100271544; 4100269970; 4100268693; 4100267245; 4100265930; 4100264695; 4100263580; 4100262073; 4100260749; 4100259294; 4100258041; 4100256558; 4100254300; 4100253637; 4100243130; 4100241888; 4100240692; 4100239324; 4100238183; 4100236832; 4100235771; 4100234597; 4100232998; 4100232190; 4100230520; 4100229264; 4100228088; 4100226938; 4100225617; 4100224715; 4100223221; 4100221952; 4100221045; 4100219439; 4100215576; 4100214281; 4100213246; 4100211933; 4100211056; 4100209898; 4100208871; 4100207555; 4100206958; 4100205556; 4100204906. Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Blood and Blood Products for Reprocessing W036510090662 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. LifeShare Blood Centers
Food Baugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part ***Fresh*** Preservatives added-keep under refrigeration***. Jugs are labeled in part ***FDA Required Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems***. The products are not identified with lot numbers. The jugs are labeled with UPCs: 710372330024 710372330017 Class I An unpasteurized apple cider product is potentially linked to foodborne illnesses in cases confirmed with E. coli 0157:H7. Baugher Enterprises, Incorporated
Biologics Red Blood Cells Leukocytes Reduced 20KV51488, 020L53142, 20KK78860; 20X73265, 20FW41272; 20X72735, 20X72392; 20L51192; 20LW33694; 020x74860; 20FW48207; 20KK82966; 20KK82969; 20KV57460, 20LW41602; 20LW41776;20X81069, 20X81089, 20X74714; 20X77093; 20X77875; 020L53298; 20LW36510;20X76725; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Devices Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. Lots 202028 and 202722 Class II Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. Covidien LLC dba Uni-Patch
Devices Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. Lots 202404, 202506, 203431, Class II Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. Covidien LLC dba Uni-Patch
Devices Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation. Lot 202406 Class II Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. Covidien LLC dba Uni-Patch
Devices Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation. Lots 200300 and 201203 Class II Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. Covidien LLC dba Uni-Patch
Veterinary Bulk Broiler Feed labeled as WD-2 All feed distributed from source bin 860 on 08/02/12. Class III The feed contains undeclared Larvadex. PECO Foods Inc.
Drugs Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1. 62QJ, Exp 12/11 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. Physicians Total Care, Inc.
Drugs Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1. Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. Physicians Total Care, Inc.
Drugs Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1. Lot # 62QH, Exp 4/12 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. Physicians Total Care, Inc.
Biologics Red Blood Cells Leukocytes Reduced W12701282750300; Class II Blood products, which did not meet the acceptable product specifications, were distributed. ONEBLOOD Inc DBA: Southeastern Comm. Blood Center
Biologics Red Blood Cells Leukocytes Reduced 22FX86182; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross, Penn-Jersey Region
Biologics Blood and Blood Products for Reprocessing 22FX86182; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross, Penn-Jersey Region
Biologics Red Blood Cells Irradiated W141608132395; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells W141608134667; W141607089713; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced Irradiated W141609135513; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced Irradiated W141609135513; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Blood Products - Other W141609135513; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced 06GL92017; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross The
Biologics Cryoprecipitated AHF 06GL92017; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross The
Biologics Platelets Pheresis Leukocytes Reduced W010012200086; W010012200163; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Department Of The Army
Biologics Blood and Blood Products for Reprocessing W010011008546; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Department Of The Army
Biologics Fresh Frozen Plasma W010012200086; W010012200125; W010012200163; W010012000827; W010012002215; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Department Of The Army
Devices AMPLILINK software, For use with COBAS® AmpliPrep instrument, COBAS® TaqMan® analyzer, COBAS® TaqMan® 48 analyzer, COBAS® AMPLICOR® analyzer, and Cobas p 630 instrument AMPLILINK software is used to integrate all instruments and analyzers offering a single user interface for PCR testing. AMPLILINK version 3.3 and 3.2 Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. MagNA Pure LC version 3.0 Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays. Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices Roche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis. Roche LightCycler 2.0 Instrument with software version 4.1. Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices cobas® 8000 modular analyzer series The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests. cobas® 8000 modular analyzer series Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices cobas® Integra 400/400 Plus (Software version 3.4) The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids. cobas® Integra 400/400 Plus (Software version 3.4) Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Instrument Manager version 8.04. Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. DataCare GM Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Devices DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data. DataCare POC Class II Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ . Roche Molecular Systems, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 007GG29014 Part A ; 007GG29014 Partt B; Class III Blood products , in which extra amount of red cell preservative solution was added, were distributed. American National Red Cross, The
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036810810072; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036810133837; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036810133837; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036812378958; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036812378958; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Source Plasma 0130197454; 0130197627; 0130198664; 0130199217; 0130200183; 0130200684; 0130201542; 0130202069; 0130202716; 0130203363; 0130203497; 0130204401; 0130204924; 0130205769; 0130206292; 0130207083; 0130207418; 0130208006; 0130208347; 0130209547; 0130210067; 0130210650; 0130211189; 0130211872; 0130212389; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Biomat USA, Inc.
Biologics Source Plasma 0640291398; Class II Blood product, collected from a deferred donor due to risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Biomat USA, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W1151122564178; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Food Longhorn Bar Roasted Peanut with Chocolate (1.23 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and chocolate. The UPC code for the Roasted Peanut Energy Bar is 8-57087-00301-7 and best by date of 11/10/12. The lot Number is 111012. These codes are printed on the back of the products. Class I LIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have the potential to be contaminated with Salmonella, 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. This recall was initiated because these products were made using peanuts from Sunland Inc. which has issued an expanded recall of the peanuts used in these products. Lin-Mar Partners Inc
Food Longhorn Bar Peanut Butter Trail Mix (1.80 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and trail mix. The UPC code for the Peanut Butter Trail Mix Protein Bar is 8-57087-00303-1 and best by date of 11/11/12. The lot Number is 111112. These codes are printed on the back of the products. Class I LIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have the potential to be contaminated with Salmonella, 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. This recall was initiated because these products were made using peanuts from Sunland Inc. which has issued an expanded recall of the peanuts used in these products. Lin-Mar Partners Inc
Devices MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183 Class II A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. Siemens Medical Solutions USA, Inc
Devices Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680; all serial numbers Class II The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. Hospira Inc.
Devices Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. pump list number 11005 and module list number 11006; all serial numbers Class II The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. Hospira Inc.
Devices Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature. pump list numbers 20679 and 20792, and module list number 20677; all serial numbers Class II The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. Hospira Inc.
Devices Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue. Baby Quasar- Model BQ-101, UPC Code 6 89076290272, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767. Baby Quasar Pink- Model BQ-101-P, UPC 837654072172, Batch # 11927, 11945, 11989, 11990 12017,12073. Class II Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Quasar Bio-Tech, Inc. dba Silver Bay LLC
Devices Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue. Quasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521. Class II Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Quasar Bio-Tech, Inc. dba Silver Bay LLC
Devices Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***" Quasar Power Pack- Model BPP-101 UPC Code 837654050170, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767. Class II Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. Quasar Bio-Tech, Inc. dba Silver Bay LLC
Food Cold-Smoked Atlantic Salmon in vacuum packed plastic, labeled in part: "FOPPEN NORWEGIAN SMOKED SALMON SLICES INCLUDES PACKET OF HONEY MUSTARD DILL SAUCE READY TO EAT PEPPERED TRADITIONAL DILL NET WT 12oz / 341g (291g Salmon + 50g Sauce 8 712224 129277***INGREDIENTS SALMON: Atlantic Salmon (Salmo salar), salt, pepper, dill, paprika, parsley, smoke, color added***Manufactured by: Foppen Salmon Daltonstraat 24, 3846 BX HARDERWIJK, The Netherlands***" Expiration dates between 10.1.12 - 10.27.12. Class II Salmon was produced in a plant in Greece, owned by Foppen of the Netherlands, where Salmonella was found on one of the lines. Costco Wholesale
Devices DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM). K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001 Class II There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations. Mindray DS USA, Inc. d.b.a. Mindray North America
Food Ella's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box Best By 5/07/2013 and 5/16/2013 Class III Cookies may contain mold. Ella's Kitchen
Food Ella's Kitchen yum yummy apple + ginger baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000533 packaged in a chipboard carton with 12 cookies per box Best By 5/16/2013 Class III Cookies may contain mold. Ella's Kitchen
Devices The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. Serial numbers range for GVL3: 0574-0007/ MD10500 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798. Class I Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking. Verathon, Inc.
Devices Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171. Class II It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper limit of the tolerance level which could lead to a significant increase in the out-of box failure rate. Roche Diagnostics Operations, Inc.
Devices Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. All lot codes Class II Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. All lot codes Class II Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. All lot codes Class II Operating range of the ADVIA Centaur systems is 18C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems All lot codes Class II Operating range of the ADVIA Centaur systems is 18C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems. All lot codes Class II Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems. Al lot codes Class II Operating range of the ADVIA Centaur systems is 18C° to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Devices Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems. All lot codes Class II Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. Siemens Healthcare Diagnostics, Inc
Food Turkana Valley Dried Apricot 250 g, UPC 8692594007804 and 500 g UPC 8692594007811 Tunas Gida, San Ve Tic. Ltd. Sti 2 Org. San. Bol. Celal Dogan Bulvari No.:3 Baspinar Gaziantep/ Turkey packaged in plastic container 250 g- Best Before 02/2013 Lot #11-4 500 g- Best Before 02/2013 Lot #11-3 Class I Turkana Valley dried apricots contain undeclared sulfites which was discovered during NYSDAM sampling. Turkana Food Inc.
Devices Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. Catalog No. RTU-TdT-339, lot numbers 6001845, expiry 2012-11 and 6009645, expiry 2014-04 The recall also included the folowing expired lots: 804804, 804805, 804806, 804809, 804810, 804812 Class II RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. Leica Microsystems, Inc.
Food Berres Brothers Coffee Roasters Chocolate & Peanut Butter regular whole bean coffee packaged in the following sizes: 12 oz. (340g) UPC 746774-003594 and 5 LB bulk, UPC 746774-00499. Julian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated whole bean coffee packaged in 12 oz. (340g) bags with no UPC code. Julian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Chocolate & Peanut Butter regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-00042, 2.5 oz. with no UPC, and 12 oz. (340g) bags with UPC 746774-00359. Julian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC. Julian date codes 12001 - 12318 (January 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Mocha Monkey regular whole bean coffee packaged in 5 lb bulk bags with UPC 746774-00509. Julian date codes 12271 - 12318 (September 27 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Mocha Monkey regular ground coffee packaged in 1.5 oz. (42.5g) bags with UPC 746774-000425. Julian date codes 12271 - 12318 (September 27 1, 2012 thru November 13, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Lunch with Elvis regular whole bean coffee packaged in the following sizes: 12 oz. (340g) bags with no UPC, and 5 lb bulk bags with UPC 746774-5093 Julian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Lunch with Elvis decaffeinated whole bean coffee packaged in 12 oz. (42.5g) bags with no UPC. Julian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Lunch with Elvis regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-000425, and 12 oz. (340g) bags with no UPC. Julian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Food Berres Brothers Coffee Roasters Lunch with Elvis decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC. Julian date codes 12091 - 12319 (April 1, 2012 thru November 15, 2012) Class I Berres Brothers Coffee Roasters is recalling 3 flavors of regular and decaffeinated, ground and whole bean coffees because they contain undeclared walnut. Chocolate & Peanut Butter, Monkey Mocha, and Lunch with Elvis Berres Brothers, Inc.
Devices Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421  M3170 Patient Link 865416  M3177 Trend Display 865422   ...
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Class II Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms. Philips Healthcare Inc.
Devices SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual. All SynchroMed EL and SynchroMed II pumps Class I Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. Medtronic Neuromodulation
Devices Medtronic SynchroMed II, Model 8637, (The SynchroMed® II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. All SynchroMed EL and SynchroMed II pumps Class I Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. Medtronic Neuromodulation
Devices BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds*** Lot number 2089253 Class II In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens. Becton Dickinson & Co.
Devices WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. Begining Lot 1207251, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210151. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the  ...
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Class II ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user. ConMed Corporation
Devices WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. Beginning Lot Code 1209171, Ending Lot Code 1210101. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift  ...
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Class II ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user. ConMed Corporation
Devices WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. Begining Lot 11207241, Ending Lot Code 1207251; Beginning Lot Code 1209171, Ending Lot Code 1210081. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the  ...
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Class II ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user. ConMed Corporation
Devices WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. Beginning Lot Code 1209171, Ending Lot Code 1209201. Lot codes on boxes and packaging contain a lot code in the following form 12 09 17 1 where 12 represents the year (2012), 09 represents the month (September), 17 is the day of the month, and 1 is the Manufacturing Shift  ...
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Class II ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user. ConMed Corporation
Devices STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles. Lot: 225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117 270117 313117 341111 241117 273117 314117 343111 242117 275117 315117 348111 243117 277117 316117 350111 244117 278117 317117 245117 280117 318117 246117 281117 319117 249117 282117 321111 253117  ...
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Class II Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life. Advanced Sterilization Products
Food Pure Apricot Pecan Flats, 10 units/case, 6oz. UPC 8 73376 00303. All lot codes Class III Unified Grocers is recalling Pure Apricot Pecan Flats because it may contain undeclared sulfites. Unified Grocers Inc.
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