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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated KN07457 Class II Blood product, collected from a donor who disclosed taking a daily dose of Aspirin , was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells T23108 Class II Blood product, manufactured from an overweight whole blood unit, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Fresh Frozen Plasma Y42952 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced C72367 Class III Blood product, which did not have the correct amount red cell preservative solution added, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing GH01615; GH00089 Class III Blood products, which did not meet the acceptable product specifications, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced C74031 Class II Blood product, which tested as CMV positive but labeled as CMV negative, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced G177400 Class II Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced 02GG13901 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02GG13901 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells (Apheresis) 4045540 Class II Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. . University of Texas Medical Branch at Galveston (The)
Biologics Source Plasma 06DTXC0279 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 02LC78216 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 02LC78216 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 011LT11137, 011LT11139 (2 units), 011LT11140, 011LT11141 (2 units), 011LT11142, 011LT11143 (2 units), 011LT11145, 011LT11146 (2 units), 011LT11148 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced W045007912369A; W045007912369B Class II Blood products, with positive bacterial detection testing, were distributed. Community Blood Center Of Gtr KC
Biologics Plasma Frozen 011FL56125 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W045006108058;W045006108058 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced Irradiated W045007010581 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W045007001094;W045007001094 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced W045007142019 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma W045007010581 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced 115998840 Class III Blood products, which were possibly contaminated, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 115998840 Class III Blood products, which were possibly contaminated, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W04110800723900 (2 units) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced W141608213448 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells W141608630171. Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Puget Sound Blood Center and Program
Biologics Blood and Blood Products for Reprocessing W141608007333 Class III Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed. Puget Sound Blood Center and Program
Biologics Source Plasma BY0261044, BY0261311, BY0261769, BY0261701 Class II Blood products, which were not quarantined after receiving post donation information regarding an undocumented piercing, were distributed. DCI Biologicals Bryan LLC
Biologics Red Blood Cells Leukocytes Reduced W045008003256, W045008057390 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of Greater Kansas City
Biologics Fresh Frozen Plasma W045008003256 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of Greater Kansas City
Biologics Recovered Plasma W045008057390 Class II Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed. Community Blood Center of Greater Kansas City
Biologics Red Blood Cells Leukocytes Reduced Irradiated 004E25878, 004E25879, 004F77446, 004FJ44307, 004FJ44310, 004J10528, 004J10531, 004N71839, 004N71842, 004N71862, 004N71866, 004N71867, 004N71875 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 004E25855, 004E25857, 004E25868, 004F77410, 004F77419, 004F77468, 004FJ44301, 004FJ44308, 004J10538, 004J10546, 004M56906 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 004FG06539 (Parts 1 & 2), 004FH06057 (Parts 1 & 2), 004FP94622 (Parts 1 & 2), 004FP94628, 004FP94631 Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 004FG06532, 004FG06535, 004FP94622, 004FP94623, 004FP94626, 004FP94628, 004FP94630, 004GC27533, 004FG06537 (Parts 1 & 2), 004FH06061 (Parts 1, 2, & 3), 004FH06063 (Parts 1 & 2), 004FP94620 (Parts 1 & 2), 004FP94627 (Parts 1, 2, & 3), 004FP94629 (Parts 1 & 2), 004FP94631 (Parts 1 & 2) Class III Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed. American National Red Cross (The)
Biologics Source Plasma 3330029477, 3330027679, 3330027202, 3330025120, 3330024506, 3330024164, 3330023581, 3330023226, 3330022681, 3330022333, 3330021059, 3330020730, 3330020209, 3330019963, 3330019508, 3330019196, 3330018730, 3330018444, 3330018035, 3330017783, 3330030309, 3330018282, 3330018712, 3330019199, 3330025765, 3330026011, 3330024976, 3330024363, 3330024052, 3330023419, 3330023101, 3330022517, 3330022195, 3330021609, 3330021307, 3330020758, 3330020486, 3330019998, 3330019726, 3330019222, 3330018765, 3330018494, 3330018062, 3330017810, 3330026718, 3330026182, 3330024953, 3330023960, 3330023396, 3330022135,  ...
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Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 0660055061, 0660054502, 0660054240, 0660049416, 0660048942, 0660048564, 0660047987, 0660047710, 0660047085, 0660046742, 0660046235, 0660045960, 0660045588, 0660045338, 0660044759, 0660044393, 0660043882, 0660043549, 0660041282, 0660040566, 0660040325, 0660039692, 0660039074, 0660038222, 0660037800, 0660037736, 0660037193, 0660036536, 0660036319, 0660035739, 0660035564, 0660035055, 0660034745, 0660034036, 0660033826, 0660033293, 0660032698, 0660032218, 0660031927, 0660031452, 0660031150 Class II Blood products, collected from a donor with a history of incarceration, were distributed. Biomat USA, Inc.
Biologics Source Plasma 4220524051, 4220494958, 4220494293, 4220491853, 4220489422, 4220487129, 4220486475, 4220484309, 4220483659, 4220481231, 4220480399, 4220478728, 4220477840, 4220475733, 4220474704, 4220472654, 4220471314, 4220444494, 4220443659, 4220441380, 4220438250, 4220435898, 4220434960, 4220432970, 4220432061, 4220430182, 4220429369, 4220427170, 4220424871, 4220424060, 4220422093, 4220421302, 4220419533, 4220418804, 4220417064, 4220416438, 4220414286, 4220412438, 4220411684, 4220409165, 4220408380, 4220406850, 4220361334, 4220360279, 22BJSXJX, 22BJSWSB, 22BJSTQH, 22BJSTDM, 22BJPWZT, 22BJRVCR,  ...
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Class II Blood products, collected from donors who were previously deferred for high risk behavior, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 0750007513 ;0750007843 ;0750008087 ;0750008301 ; 0750008547 ;0750000881 ; 0750009025 ;0750009484 ; 0750009742 ;0750010030 ;0750010314 ;0750010775 ; 0750011032 ;0750011312 ;0750011547 ;0750011877 ; 0750012029 ;0750012316 ;0750012601 ;0750012935 ; 0750013195 ;0750013556 ;0750013768 ;0750014035 ; 0750014273 ;0750014558 ;0750014804 ;0750015046 ; 0750021576 ;0750021705 ;0750022226 ;0750022421 ; 0750022825 ;0750023063 ;0750023388 ;0750023759 ; 0750024210 ;0750024500 ;0750024981 ;0750025221 ; 0750025577 ;0750026013 ;0750026548 ; 0750027012 ;0750027282 ;0750028041 ;0750028455 ; 0750028661 ;0750029157  ...
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Class II Blood products, collected from a donor who was previously deferred, were distributed. Biomat USA, Inc.
Biologics Platelets Leukocytes Reduced W067311002332A; W067311002638A; W067311002346A; W067311002603; W067311002663; W067311002665; W067311002723; W067311002327; W067311002326; W067311002329; W067311002722A; 067311002722B; W067311002545; W067311002332B;W067311002638A; W0673110026142A; W0673110026142B Class II Blood products, for which the sterility may have been compromised, were distributed. Coffee Memorial Blood Center, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W067311002604; W067311002662; W067310026142A; W067310026142B; W067311002329; W067311002722; W067311002338 Class II Blood products, for which the sterility may have been compromised, were distributed. Coffee Memorial Blood Center, Inc.
Devices Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system. Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061. Class II The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness. Abbott Vascular
Devices AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Mfg Lot or Serial # 00000L022E05AE 00000139595HP3 000000010003GS 000000410012GS 000000210016GS 000000210013GS 00000138998HP0 00000139435HP2 000000410010GS 000000410009GS 000000210005GS 000000210011GS 000000210012GS 000000210015GS 00000138991HP5 000000210014GS 000000310005GS 00000139574HP8 00000139604HP3 00000L026CC222 000000210010GS 000000010004GS 000000410011GS 000000410007GS 000000210023GS 000000210025GS 000000210026GS 000000210022GS 000000210024GS 000000410005GS 000000410006GS 000000310003GS 000000310002GS 000000210006GS 000000210007GS 000000210003GS 000000410004GS 000000310001GS 000000010001GS 000000210030GS 000000210008GS 000000410016GS 000000P8059001 000000210027GS 000000410008GS 000000410001GS 000000210017GS 000000210019GS 000000210021GS 000000210020GS 000000310008GS 000000210018GS 000000410014GS 000000210029GS 000000210004GS 000000210001GS 000000210009GS 000000410003GS 000000410013GS 000000210028GS 000000410017GS 000000410015GS 000000310007GS 000000310006GS 000000010005GS Class II It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient. GE Healthcare, LLC
Devices Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products Motorola Solutions PCS3000/CS3070 Laser Class II It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label. Motorola Inc
Devices Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. All lots Class II A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. Varian Medical Systems, Inc.
Devices Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. All lots Class II A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. Varian Medical Systems, Inc.
Devices Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications. 003, 509350004, 509350005, 509350006, 509350007, 509350008, 509350009, 509350010, 509350011, 509350012, 509350013, 509350014, 509350015, 509350016, 509350017, 509350018, 509350019, 509350020, 509350021, 509350022, 509350023, 509350024, 509350025, 509350026, 509350027, 509350028, 509350029, 509350030, 509350031, 509350032, 509350033, 509350034, 509350035, 509350036, 509350037, 509350038, 509350039, 509350040, 509350041, 509350042, 509350043, 509350044, 509350045, 509350046, 509350047, 509350048, 509350049, 509350050, 509350051, 509350052,  ...
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Class II The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line. MOOG Medical Devices Group
Biologics Red Blood Cells Leukocytes Reduced W036812426425; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W141610132562; Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced Irradiated W141610155472; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Fresh Frozen Plasma W141610154831; 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 W141610157832; W141610157430; 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 (Apheresis) Leukocytes Reduced W038112114651A; W038112114651B; Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W0352120385900; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets W0352120385900; W035212226967D; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W0352120385900; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W141610018913; W141610048862; 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 W141611017625; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. Puget Sound Blood Center and Program
Biologics Platelets Pooled Leukocytes Reduced W044112124744; Class II Blood product, which tested negative for viral markers, but was collected from a donor that subsequently reported a previous history of positive test hepatitis, was distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W036812538893; Class II Blood product, which did not meet acceptable product specifications, was distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036212518486; Class II Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed. Belle Bonfils Memorial Blood Center
Biologics Platelets W333612094877; Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Mississippi Valley Reg Bld Ctr
Devices Mindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 0C000569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373 Class II Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. Mindray DS USA, Inc. d.b.a. Mindray North America
Devices Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant. Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08. Class II Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected). Extremity Medical LLC
Drugs Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. Lot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A,  ...
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Class I Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Devices Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device REF cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures. Model EX500: Lot #'s: 15410906, 15411659, 15424968, 15429098, 15429879, 15437509, 15437958, 15444208, 15449422, 15453540, 15456567, 15456568, 15462779, 15462780, 15469984, 15479199, 15481341, 15485491, 15489970, 15501955, 15505186, 15578709, 15589368, 15586530, 15602199, 15603369, 15608590, 15610801, 15617548, 15630141, 15630171, 15639388, 15642692, 15648662, 15650923, 15656441, 15664083, 15670351, 15670768. Model EX600: Lot #'s: 15408606, 15409332, 15410622, 15410623,  ...
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Class II On 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700. Cordis Corporation
Food Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440. Case UPC code 1600040993000 Consumer package code: Better Used By 14SEP2013 Case code: 14SEP3LD Class II General Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake because of a labeling issue. Some product was packaged incorrectly, and contains undeclared FDandC color ingredient not listed on the box's ingredient label. The undeclared colors are: Yellow 5, Yellow 6, Red 40 and Blue 1. General Mills, Inc
Devices Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument. Lot Number 155599 Class II Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. Alfa Wassermann, Inc.
Devices Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 : Class II Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21 Philips Healthcare Inc.
Devices Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053 Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510 Lot# EMC0004304 EMC0004797 Lot# EMC0003827 EMC0004233 Class II Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference. Envoy Medical Corporation
Drugs Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033 Lot: 0NCW005, Exp 02/2013 Class II Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring. Schering-Plough Products, LLC
Devices Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System. Lot#C2510 and C2510A Class III Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results. Alere San Diego, Inc.
Devices Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals. Lot#271097 Class III Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results. Alere San Diego, Inc.
Devices Ortho Clinical Diagnostics VITROS® Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS® Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS® 3600, VITROS® 5600, and VITROS® ECi/ECiQ Systems. CAT No. 680 0100; the cartridges do not have lot numbers. Class II Some VITROS® Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS® System instead of the intended VITROS® Vapor Adsorption Cartridge which may bias results. Ortho-Clinical Diagnostics
Food Individual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: "The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.*** UPC' #s = L72483N, L49983N, and L49983N SKU # 49983, 72483, and 63583 Class III Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1). The Father's Table, LLC
Food Individual packages labeled in part: ***The Bakery baked with pride***Vanilla Mini Cake Roll***8oz**** with strawberry filling*** NETWT 8oz (226g) UPC' #s = L02367N SKU # 02367 Class III Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1). The Father's Table, LLC
Food WP Saki Ika Cuttlefish JFC# 15603, 4/24/0.75oz; JFC# 06315, 8/12/2oz; JFC# 07266, 5/12/4oz; JFC# 06375, 3/12/8oz. JFC# Lot# 15603 Q066A & Q109A; 06315 Q065A & Q108A; 07266 Q067A & Q110A; 06375 Q066A & Q109A. Class III JFC International is recalling WelPac Saki Ika Cuttlefish because of mold. J F C International Inc
Food WP Saki Ika Cuttlefish Hot JFC# 15606, 4/24/0.75 oz; JFC# 06318, 8/12/2 oz; JFC# 07269, 5/12/4 oz; JFC# 06360, 3/12/8 oz. JFC# Lot# 15606 Q069A & Q110A; 06318 Q068A & Q111A; 07269 Q070A & Q112A; 06360 Q069A & Q112A. Class III JFC International is recalling WelPac Saki Ika Cuttlefish because of mold. J F C International Inc
Food Chocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package) or in 0.5 lb and 1 lb. boxes. The 2-ounce package has a UPC 19815 90007 8. There is no UPC for 0.5 lb. and 1 lb. packages. The product is labeled in parts: "***Chocolate Covered Coconut Balls***CHOCOLATE DECADENCE***Net Wt. 2oz (56.7g)***INGREDIENTS: Semi-sweet chocolate (sugar, None Class II There is a potential of cross contamination with peanuts. The Chocolate Covered Coconut Balls were dipped in the same pot of melting chocolate that was used to make product containing peanut butter. Chocolate Decadence
Food Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case Product code 620133006009 and lot BB2013DE13 Class I Kinnikinnick Foods Inc., a Canadian manufacturer notifed Jerusalem Manufacturing Natural Food and Wholesalers, Inc. in Dearborn, MI to recall the Kinnikinnick Foods Brand Frozen Pies, 290g/10 ounces. 2 crusts per box, 6 boxes per case due to EGG not declared on the label. Jerusalem Manufacturing Natural Foods & Wholesalers, Inc.
Devices COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits. Class II The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50. Roche Molecular Systems, Inc.
Devices TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction. Catalog Number: 909668 Lot Number Identification: 716710 Class II Thru hole at the tip of the screw is undersized. Biomet, Inc.
Devices BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use. Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013 Class II Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species. Becton Dickinson & Co.
Food Food Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL. NOV 28 13 DO2, use by 11/28/2013 Class I The product contains walnuts and it was packaged in the wrong carton. Due to the mis-packaging the ingredient label does not have walnuts listed. Gilster-Mary Lee Corp.
Devices BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL Lot No. 2180434; Expiration Date: April 2013 Class II BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. Becton Dickinson & Company
Food Growth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow. Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers, pharmaceutical laboratories and governmental research facilities. SRK91512; SRK92112; SRK92512; SRK102312; SRK11412; SRK111912. Class II Eon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria. EonNutra, LLC
Drugs Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738 0.9 mg: 512348A Class III Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Warner Chilcott Company LLC
Drugs Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738 0.45 mg: 505969A Class III Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Warner Chilcott Company LLC
Drugs HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03 Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14 Class II Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. Hillyard GMP
Food Kitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628 Lot 12257 and Lot 12258 Class II The product contains Soy and Wheat and is packaged in cartons in which the ingredient statement is missing. C H S Inc
Devices BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. Catalog Number: 259789, Lots/Batch: 1031866 Class II BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. bioMerieux, Inc.
Devices Ethicon Endo-Surgery Inc. The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545 Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date  ...
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Class II Ethicon Endo-Surgery initiated a voluntary global recall for all production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to a potential for self activation while the device is in use, which may result in unintended thermal damage. Ethicon Endo-Surgery Inc
Food Kinnikinnick Foods Pie Crusts, 10.2 oz, Item code: 21-35265, UPC 6-20133-00600. Lot code: BB2013DE12 Class I Unified Grocers is recalling Kinnikinnick Pie Crust because it contains undeclared egg allergen. Unified Grocers Inc.
Food Kinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9 BB2013DE13 Class I Kinnikinnick Foods, Inc in Edmonton, Alberta Canada indicated that KeHE Distributors in Bloomington, IN had received pie crusts in association with their recall/allergy alert issued 12/28-29/2012 KeHE/Tree of life Bloomington
Food Spice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188. UPC Code 84670200985 Manufacturing Date Codes (printed on the inside seam/gusset of the bag): 08/01/2012, 08/23/2012, 10/03/2012, 11/18/2012, 11/19/2012. Class I Undeclared Allergen (Milk). Firm initiated a voluntary recall of their 25 lb. and 50 lb. bags of Spice Cake Mix that had been distributed since August 2012 due to an undeclared allergen, milk. The Spice Cake Mix is manufactured for correctional facilities/institutions only. Jiffy Food Service, LLC
Devices Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system. Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01. Class III Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received. Siemens Healthcare Diagnostics, Inc.
Food ***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***. Product ID# 536030, best by Feb 12 2013 Class II Concern with Time/Temperature abused during transit. Gordon Food Service, Inc.
Food Island Delights Coconut Haystack Candy Maple Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***NATURAL MAPLE FLAVOR***Island Delights, Inc. Seville, OH 44273" 2 oz, Lot #13410400.02, UPC Code 0 19694 19020 1 4 oz, Lot #13410400.04, UPC Code 0 19694 19040 9 8 oz, Lot #13410400.08, UPC Code 0 19694 19080 5 2 lb, Lot #13410402.00, no bar code Class I During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement. Island Delights, Inc.
Food Island Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL ALMOND FLAVOR***Island Delights, Inc., Seville, OH 44273" 2 oz, Lot #13413100.02, UPC Code 0 19694 71020 1 4 oz, Lot #13413100.04, UPC Code 0 19694 71040 9 8 oz, Lot #13413100.08, UPC Code 0 19694 71080 5 2 lb, Lot #13413100.00, no bar code Class I During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement. Island Delights, Inc.
Food Island Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc. Seville, OH 44273" 2 oz, Lot #13411300.02, UPC Code 0 19694 60020 5 4 oz, Lot #13411300.04, UPC Code 0 19694 60040 3 8 oz, Lot #13411300.08, UPC Code 0 19694 60080 9 Class I During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement. Island Delights, Inc.
Food Island Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part "INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc., Seville, OH 44273" 2 oz, Lot #13413000.02, UPC Code 0 19694 70020 2 4 oz, Lot #13413000.04, UPC Code 0 19694 70040 0 8 oz, Lot #13413000.08, UPC Code 0 19694 70080 6 2 lb, Lot #13413002.00, no bar code Class I During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement. Island Delights, Inc.
Food Ocean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc. 1/9/13 -3/05/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Ocean Harbor Cajun Krab Spread Net Wt 5 lb (2.27 kg) UPC: 0 32345-77711 8 Dist by Roundy's Inc. 1/9/13 -3/05/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Ocean Harbor Jalapeno Krab Spread Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6 Dist by Roundy's Inc. 1/9/13 -3/05/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Five Star Dip Smoked Salmon Dip Net WT 10 oz (284g). UPC: 0 32345 61463 5 Mfg By Dawn Food, Portage, WI 53901. Dawns Smoked Salmon Dip NET WT 5 LBS (2.27 kg) UPC: 0 32345 61480 2 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 1/9/13 -3/05/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Five Star Dip Cajun Krab Dip Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901. 84080 Dawns Cajun Krab Dip NET WT 5 LBS (2.27 kg), UPC: 0 32345 88888 3 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 1/9/13 -3/05/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Dawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 70103 8 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 Ocean Harbor Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77701 9 Dist by Roundy's Inc. 1/9/13 -2/19/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Food Dawns Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 85072 9 , MFG BY DAWN'S FOODS, IN., PORTAGE, WI 53901 Ocean Harbor Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 77705 7, Dist by Roundy's Inc. 1/9/13 -2/19/13 Class II Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers. This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth. Dawn's Foods, Inc.
Devices HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics Software Versions 1.1.2 and below; Part numbers 161005, 161006. Class I Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected. Hamilton Medical Inc
Devices 45° Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill). All lots Class II Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45° product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers. Greatbatch Medical
Devices KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography Lot 2114596 (Exp. September 2014) Class II The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number 8118226 have missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. Carestream Health, Inc.
Food Knott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE 38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326 all date codes up to and including 01/29 Class I Sample collected by State of Tennessee Department of Agriculture was found to contain Listeria Monocytogenes Knotts Wholesale Foods Inc
Food DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990. Dymatize Nutrition Elite Gourmet Cookies & Cream 1.5oz (42.5g), UPC Code, 705016993147, Lot # 12200A, Best By Date SEP 2013, Lot # 12249A, Best By Date NOV 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Cookies &  ...
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Class I Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein. Belmont Confections Inc
Food DYMATIZE NUTRITION ELITE Gourmet Fudge Brownie 6-LAYER HI-PROTEIN BAR Label reads in part "NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990. Dymatize Nutrition Elite Gourmet Fudge Brownie 1.5oz (42.5g), UPC Code, 705016993130, Lot #, 12199A, Best By Date SEP 2013, Lot # 12244A, Best By Date OCT 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Fudge Brownie 3oz  ...
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Class I Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product. The consumer is allergic to peanuts & peanut protein. Belmont Confections Inc
Drugs Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14 Class II Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. Mylan Pharmaceuticals Inc.
Food Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9 Expiration date 2013-12-11 Class I Kinnikinnick Foods, Inc. in Edmonton, Alberta Canada indicated that United Natural Foods Inc. distributors received pie crusts in association with their expanded recall/allergy alert issued 01/17/13. United Natural Foods, Inc. - Greenwood
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