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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 011LQ56363 Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Cryoprecipitated AHF 011FS50120 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 011FS50120 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 011FS50120 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing C71385 Class II Blood product, collected from a donor with non-confirmed repeat reactive HBsAg, was distributed.. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced C72530 Class II Blood product, which tested as CMV positive but labeled as CMV negative, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced KN03020 Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced 2025841 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Siouxland Community Blood Bank
Biologics Blood and Blood Products for Reprocessing 2025841 Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Siouxland Community Blood Bank
Biologics Fresh Frozen Plasma 020Q 10574 , 020Q 10575. Class II Blood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020J 61790 , 020J 61792 , 020J 61796 , 020J 61797  ...
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Class II Blood products, which was collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 71X45517-7 Class II Blood product, with a low platelet count, was distributed LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 11KS13328 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 11FY34707 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 011LK58056 Class II Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 21FJ51269 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21FJ51269 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W141608213600 Class II Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed. Puget Sound Blood Center and Program
Biologics Blood and Blood Products for Reprocessing R305763 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Puget Sound Blood Center and Program
Biologics Platelets W141608415198 Class II Blood product, which was collected from a donor in whom donor suitability was not adequately determined, was distributed. Puget Sound Blood Center and Program
Biologics Red Blood Cells Leukocytes Reduced 011LQ61233 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 Plasma Frozen 011LQ61233 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 Red Blood Cells Leukocytes Reduced 011KJ12276; 011KX08948 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 011KJ12276;011KX08948 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)
Food Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831 Peanut Butter Pieces Catalog #107, Milk Chocolate Clusters Catalog #111 & Dark Chocolate Clusters Catalog #112 Date Codes 121401-130831 Class I This product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella Giannios Candy Co Inc
Biologics Source Plasma 380098221, 380091801, 380095082, 380102319, 380093481, 380113918, 380106427, 380096985, 3800003417, 380100217, 380100491, 380111162, 380106940, 380107283, 380108885, 380111205, 380104488, 380105322, 380103028, 380098015, 380106785, 380099826, 380095696, 380092908, 380091944, 380108728, 380092169, 3800049989, 380111054, 380106540, 380104691, 380105648, 380097869, 3800024783, 380113213, 380114842, 380112449, 380104240, 380097106, 380107764, 380108063, 380111541, 38011917, 380100306, 3800007683, 380100117,380120861, 380114378, 380113395, 380112672, 380107722,  ...
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Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Talecris Plasma Resources Inc
Biologics Source Plasma 0550856093, 0550841218, 0550840504, 0550839338, 0550837885, 0550837160, 0550835759, 0550835036, 0550833139, 0550832421, 0550831206, 0550830373, 0550829181, 0550827968. Class II Blood products, collected from a donor with an incomplete health assessment, were distributed. CSL Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced 021KS97435, 021KS97638, 021KS97647, 021KS97654, 021KS97722, 021KS97735, 021KS97737, 021KW88915, 021KW88933, 021KW88941, 021KW89609, 021KW89629, 021LH89688, 021LH89708, 021LH89774, 021LH89778, 021LH89787, 021LH89793, 021LK76002, 021LK76025, 021LL80496, 021LL80505, 021LL80557, 021LL80562, 021LL80931, 021LL81631, 021LS17820, 021LS17995, 021LS17996, 021LS18002, 021LS18022, 021LS18037, 021LS18046, 021LZ56619, 021LZ56651, 021LZ56661, Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 021LQ59071; 021LQ59071; 021LQ59673; 021LQ59673; 021LQ59915; 021LQ59915; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 021LK76013 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. American National Red Cross (The)
Biologics Source Plasma AQ127299, AQ127044, AQ126535, AQ126248, AQ125780, AQ125488, AQ125001, AQ124734, AQ124452, AQ124190, AQ123836, AQ123592, AQ123299, AQ123099, AQ121609, AQ121437, AQ122999, AQ122800, AQ122357, AQ122177, AQ120700, AQ120518, AQ120089, AQ119847, AQ119412, AQ119174, AQ118720, AQ118548, AQ118133, AQ117865, AQ117303, AQ117035, AQ116499, AQ116305, AQ115865, AQ115663, AQ115241, AQ114875, AQ114657, AQ114225, AQ114058, AQ113693, AQ113481, AQ113182, AQ112979, AQ112578, AQ112351, AQ111961, AQ111781, AQ111445,  ...
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Class II Blood products, collected from a donor who was previously deferred, were distributed. Plasma Biological Services
Biologics Source Plasma 10YARC6463; 10YARC6649; 10YARC7602; 10YARC7997; 10YARC8564; 10YARC8999; 10YARC9824; 10YARD0379; 10YARD0820; 10YARD1483; 10YARD2609; 10YARD2996; 10YARD3383; 10YARD3870; 10YARD4242; 10YARD4759; 10YARD5107; 10YARD5628; 10YARD1365; 10YARD1705; 10YARE1949; 10YARF0643; 10YARF1015; 11YARB3565; 11YARB4376; 10YARC9496; 10YARC9904; 10YARD0475; 10YARD0879; 10YARD1312; 10YARD1719; 10YARD2873; 10YARD3239; 10YARD3603; 10YARD4100; 10YARD4448; 10YARD4957; 10YARD5309; 10YARD5868; 10YARD6565; 10YARD6974; 10YARD7627; 10YARD7968; 10YARD8487; 10YARD9356; 10YARD9839; 10YARE0037; 10YARE0793; 10YARE1578; 10YARE2041;  ...
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Class II Blood products, collected from donors with incomplete physical examination, were distributed. BioLife Plasma Services L.P.
Devices Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled. Class II Unintended Fluid ingress into the device header has been shown. Advanced Neuromodulation Systems Inc.
Biologics Genzyme Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01 C0072C01 Feb 2013; C0062C01 Dec 2012; C0086C01 May 2013; C0094C01 Jul 2013; C0096C01 Aug 2013; C0098C01 Aug 2013; C0098C02 Aug 2013; C0098C03 Aug 2013; C0100C01 Aug-2013 Class II Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed. Genzyme Corporation
Devices Orthofix ISKD Limb Lengthener Sterile Rx Only, Orthofix Inc. Lewisville, TX 75056. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur. All serial numbers of the following Catalog Numbers: F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS Class II There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device. Orthofix, Inc
Drugs Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30 Lot #: C201028, Exp 12/13 Class II Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Dr. Reddy's Laboratories, Inc.
Drugs Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30 Lot #: C201922, Exp 1/14 Class II Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Dr. Reddy's Laboratories, Inc.
Drugs Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30 Lot #: C108376, C108634, Exp 11/13 Class II Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Dr. Reddy's Laboratories, Inc.
Devices Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. 1. Brilliance CT 16 slice (water): System Code #, 728245, Serial #s:2506, 2518, 2555, 2558, 2559, 2561, 2561, 2562, 2564, 2567, 2573, 2576, 2578, 2582, 2583, 2584, 2585, 2586, 2587, 2589, 2590, 2592, 2594, 2596, 2597, 3014, 3051, 3090, 3091, 3105, 3151, 3217, 3235, 3272, 3287, 3303, 3312, 3335, 3338,  ...
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Class II The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). Philips Medical Systems (Cleveland) Inc
Devices Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Systems with Eleva SW version 2.1.3 Class II When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image. Philips Healthcare Inc.
Biologics Red Blood Cells Leukocytes Reduced W036911719674; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Bank Of Delmarva, Inc
Biologics Blood and Blood Products for Reprocessing W036911719674; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Bank Of Delmarva, Inc
Biologics Platelets Pheresis Leukocytes Reduced W050912011395; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050912011395; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed HCSC-Blood Center
Biologics Source Plasma 12MKEC2429; 12MKEC1768; 12MKEC1541; YP037568; 12MKEC0329; YP037263; 12MKEB9768; 12MKEB9345; 12MKEB8835; 12MKEB8518; 12MKEB8146; 12MKEB7593; 12MKEB7276; 12MKEB6896; 12MKEB6468; 12MKEB5975; 12MKEB5649; Class II Blood products, collected from a donor who was previously deferred, were distributed. Interstate Blood Bank, Inc. of Wisconsin
Biologics Platelets Pheresis Leukocytes Reduced W280312701355; Class II Blood product, which did not meet acceptable product specifications, was distributed. Upstate New York Transplant Services
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W038612721688 Part A ; W038612721688 Part B; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced W0352112740220; Class II Blood products, collected from a donor who was previously deferred, were distributed Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W0352112740220; Class II Blood products, collected from a donor who was previously deferred, were distributed Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W035412052992; W035412053438; Class III Blood products, leukodepleted greater than three days after collection, were distributed. Community Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W035410040122; W035409008681; 3570639; 2455383; 2411381; 120869; 1252005; 1251925; 1249592; Class III Blood products, leukodepleted greater than three days after collection, were distributed. Community Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W0470100844570; W047009516690; Class II Blood products, collected from a donor who was previously deferred, were distributed. New York Blood Center, Inc.
Drugs Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962. Lot #s: a) NAA0B3T, NAA0BDB, NAA0B3P, NAA0B3R, NAA0B3N, NAA070E, NAA070F, NAA03PX, NAA03B5, NAA03B6, NAA02LT. b) NAA0TF3, NAA0TF2, NAA0TF0, NAA0TF1, NAA0TET, NAA0TEW, NAA0TEX, NAA0HHL, NAA0HHK, NAA0HHN, NAA0HHH, NAA0DK5, NAA0DK4, NAA0DK3, NAA0CHE, NAA0CHD, NAA0B3L, NAA0B3K, NAA09XE, NAA09XB, NAA07H2, NAA09XD, NAA07H1, NAA09XA, NAA09XC, NAA07H3, NAA07H4, NAA05BB, NAA05BA, NAA07H0, NAA070D, NAA070C, NAA03PW, NAA05B9, NAA070B, NAA03B8,  ...
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Class III Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label. Bayer Healthcare, LLC
Devices Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. Brilliance CT Big Bore - Model #728243 - Serial Numbers: 7006, 7007, 7008, 7009, 7013, 7014, 7015, 7016, 7017, 7018, 7019, 7020, 7021, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7035, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048,  ...
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Class II Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. Philips Medical Systems (Cleveland) Inc
Devices Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and  ...
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Class II Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. Philips Medical Systems (Cleveland) Inc
Devices Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707; GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220; GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF  ...
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Class II Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. Philips Medical Systems (Cleveland) Inc
Devices Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The affected GEMINI Big Bore system is identified with the following Serial Numbers: 9004, 9005, 9006, 9008 ,9009, 9010, 9011, 9012, 9013, 9014, 9014, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9205, 9206, 9207, 9208, 9209, 9210, 9213, 9214, 9215, 9216, 9217, 9218, 9219,  ...
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Class II Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion. Philips Medical Systems (Cleveland) Inc
Food "***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***" none Class II Undeclared allergens: FD&C Yellow #5, Yellow# 6, Red #40. Productos 2001 Inc.
Drugs Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09 Lot 238316, exp 01/31/2014 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Amedra Pharmaceuticals LLC
Drugs Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09 Lot 220839, exp 11/30/2013 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Amedra Pharmaceuticals LLC
Drugs Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09 Lot 220843, exp 11/30/2013 Class II Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Amedra Pharmaceuticals LLC
Devices QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements. All units of this model. Class II Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered. Intel-GE Care Innovations LLC
Veterinary ADM Alliance Nutrition Meat Goat Power 16% Product #80865AZN24 Lot #BF23512 Class III During an FDA inspection, the ADM Alliance Nutrition Meat Goat Power 16% (80865AZN), was run through the firm's mixer directly after lot # BF23512 of the recalled sheep feed. The Retention sample was found to have 46.4 ppm copper when the label states 25ppm-35ppm. ADM Alliance Nutrition, Inc.
Drugs Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04 18-099-DK Class II Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Hospira, Inc.
Food Homestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs. label marked with: Packed On 210 Class I The raw milk cheese product may be contaminated with shiga-toxin e-coli. Homestead Creamery
Drugs Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724 67079A; 67079B; 67079C Class II Failed Dissolution Specifications; 36 month stability timepoint West-ward Pharmaceutical Corp.
Drugs Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Lot #: 69099A, 69099B, Exp 08/15 Class II Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. West-ward Pharmaceutical Corp.
Devices GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Definium Model 5000/5220493 Class II It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000. GE Healthcare, LLC
Devices GE Healthcare Definium 5000/5220493-2 X-Ray System .This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Definium Model 5000/5220493-2 Class II It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000. GE Healthcare, LLC
Cosmetics 3D White Arctic Fresh, 32 fl oz or 946 mL, whitening oral rinse, contains alcohol, distributed by Procter & Gamble, Cincinnati, OH. Manufacturing Code: 22155395RF Class III Recalled products may have mixed during manufacturing process and products may appear cloudy and have sediment. Procter & Gamble Hair Care Llc
Cosmetics Scope Mouthwash, original mint, 1.5 L or 50.7 fl oz., distributed by Procter & Gamble, Cincinnati, OH. Manufacturing Code: 22195395ZB Class III Recalled products may have mixed during manufacturing process and products may appear cloudy and have sediment. Procter & Gamble Hair Care Llc
Drugs EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009 Class II Subpotent; bupivacaine Pacira Pharmaceuticals, Inc.
Food Whole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703 UPC code 0 99482 40880 0, Lot codes 7425A2298B and 7425A2297A. Sell by dates are applied at store level when product is thawed for sale and go 21 days out from date of thaw. Accordingly, the sell by dates should begin with 11/22/12 at the earliest and 2/15/13 at the  ...
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Class I The product has the potential to contaminated with Listeria Monocytogenes. Whole Foods Market
Food Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clover Sprouts, 1 lb bag, has a UPC 0 79566 12351 5; Clover Sprouts, 2 lb tray, has a UPC 0 79566 12351 5; The Clover Sprouts, 4 oz., Sprouters Northwest brand is labeled in parts: "***CLOVER SPROUTS***Sprouters NORTHWEST***NET WT 4.0 oz***KEEP REFRIGERATED***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***". The Clover Sprouts, 5 oz., Sprouters Northwest brand is labeled in parts: "***CLOVER ***Sprouters NORTHWEST, INC. KENT, WA 98032***NET WT 5.0 oz***KEEP REFRIGERATED***". The Clover Sprouts, 1 LB., Sprouters Northwest brand is labeled in parts: "***CLOVER SPROUTS***NET WT. 1 LB***KEEP REFRIGERATED***Sprouters NORTHWEST, KENT, WA 98032***". The Clover Sprouts, 2 LB., Sprouters Northwest brand is labeled in parts: "***Clover Sprouts***2 lb.*** Sprouters NORTHWEST, KENT, WA 98032***". The Best by Dates are including all and up to 2/17/2013. Class I Clover sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Brocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9. The product is labeled in parts: "***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts***NET WT. 4.0 oz***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***www.BroccoSprouts.com***"Growers***Sprouters Northwest (Kent, WA)***". The Best by Dates are including all and up to 2/17/2013. Class I Brocco Sprouts Sandwich Blend are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Spicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4 oz., has UPC is 8 15098 00202 3. The LifeForce, 85 gram, has UPC 8 51042 00401 9. The Sprouters Northwest, 4 oz., is labeled in parts: "***SPICY SPROUTS***a blend of clover and radish sprouts***Sprouters NORTHWEST, INC.***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***SproutersNorthwest.com***". The LifeForce, 85 gram, is labeled in parts: "***SPICY SPROUTS***a blend of clover and radish sprouts***LifeForce***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***". The Best by Dates are including all and up to 2/17/2013 Class I Spicy Sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Alfalfa sprouts, packaged in a 4 oz. clamshell container or 85 gram package. Product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4oz., has UPC 8 15098 00108 8; The LifeForce, 85 gram, has UPC 8 51042 00402 6. The Sprouters Northwest, 4oz, is labeled in parts: "***ALFALFA SPROUTS***Sprouters NORTHWEST****KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, KENT, WA 98032***www.SproutersNorthwest.com***". The LifeForce, 85 gram, is labeled in parts: "***ALFALFA SPROUTS***LifeForce foods***KEEP REFRIGERATED***NET WT 85g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***". The Best by Dates are including all and up to 2/17/2013 Class I Alfalfa sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Brocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram, produced for LIFE FORCE, has UPC 8 51042 00400 2. The Brocco sprouts, 4oz, is labeled in parts: "***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT. 4.0 oz.***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, MD 21224***Growers***Sprouters Northwest (Kent, WA)***www.BroccoSprouts.com***". The LifeForce, 85 gram, is labeled in parts: "***BROCCO SPROUTS***broccoli sprouts***Keep Refrigerated***NET WT 85 g***PRODUCED FOR: LIFE FORCE FOODS LLC, BALTIMORE, MD 21202***www.BroccoSprouts.com***". The Best by Dates are including all and up to 2/17/2013 Class I Brocco sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Deli sprouts is a mixture of Clover, Fenugreek, Lentils, an Radish sprouts. Product is packaged in a 4 oz. or 5 oz clamshell container. Product is sold under the Sprouters Northwest brand. The Deli sprouts, 4 oz., has UPC 8 79566 12305 4. The Deli sprouts, 5 oz., as UPC 0 79566 12360 7. The Deli sprouts, 4 oz., is labeled in parts: "***DELI SPROUTS***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***". The Deli sprouts, 5 oz., is labeled in parts: "***DELI***INGREDIENTS: CLOVER, FENUGREEK, LENTILS, AND RADISH***KEEP REFRIGERATED***NET WT. 5 oz.***Sprouters NORTHWEST, INC. KENT, WA 98032***". The Best by Dates are including all and up to 2/17/2013 Class I Deli sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food 3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans. Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand. Product has UPC 8 15098 00204 7. The 3 Bean Munchies sprouts, 4 oz., is labeled in parts: "***3 BEAN MUNCHIES***a blend of sprouts from green peas, cow peas, red and green lentils, and adzuki beans***KEEP REFRIGERATED***NET WT. 4.0 oz.***DISTRIBUTED BY: SPROUTERS NORTHWEST, INC., KENT, WA 98032***www.SproutersNorwthest***". The Best by Dates are including all and up to 2/17/2013 Class I 3 Bean Munchies sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Mung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand. The Life Force foods, 8 oz, has UPC 8 15098 00107 1; The Sprouters Northwest, 5 lb., has UPC 0 33383 70258 2. The Life Force foods, 8 oz., is labeled in parts: "***MUNG BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 4 OZ.***MANUFACTURED FOR: BRASSICA SPROUT GROUP, BALTIMORE, MD 21202***www.broccosprouts.com***". The Sprouters Northwest, 5 lb., is labeled in parts: "***BEAN SPROUTS***KEEP REFRIGERATED***NET WT. 5 LBS***Sprouters NORTHWEST***KENT, WA 98032***". The Best by Dates are including all and up to 2/17/2013 Class I Mung Bean sprouts are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Wheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand. The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgrass in 16 oz. bag or 5 lb. Flat cardboard box does not have any UPC. The wheatgrass, Sprouters Northwest, pint or cup., is labeled in parts: "***Wheatgrass***CERTIFIED ORGANIC***Pint***Sprouters NORTHWEST, INC.***KENT, WA 98032***". The wheatgrass in 16 oz. bag is labeled in parts: "***ORGANIC WHEATGRASS***SKU# 16OZCW***Keep Refrigerated***Not For Retail Sales as Packaged***". The wheatgrass in 5 lb. Flat cardboard box is labeled in parts: "***Wheatgrass***1 Ea. 21"X21" Wheatgrass/case***Item 40019***". The Best by Dates are including all and up to 2/17/2013 Class II Wheatgrass is recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Food Organic Pea Shoots are packaged in a 3 oz. or 4 oz packages. Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz, has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, has UPC 0092 7567. The Life Force, 3 oz, is labeled in parts: "***Organic Pea Shoots***Life Force foods***KEEP REFRIGERATED***NET WT. 3.0 oz***DISTRIBUTED BY: LIFEFORCE FOODS, LLC***BALTIMORE, MD 21202***". The Trader Joe's, 4 oz, is labeled in parts: "***ORGANIC PEA SHOOTS***TRADER JOE'S***PERISHABLE, KEEP REFRIGERATED***RINSE BEFORE USING***NET WT. 4 OZ***SKU# 92756***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016***". The Best by Dates are including all and up to 2/16/2013 Class II Organic Pea Shoots are recalled due to a potential contamination with Listeria monocytogenes. Giant Greens, Inc.
Biologics Cornea 2012010601; 2012032093; 2012042243; 2012042299; 2012053203; 2012053261; 2012064195; 2012074467; 2012074497; 2012074999; 2012085207; 2012096095; 2012106947; 2012107037; 2012107087; 2012107203; 2012107253; 2012128065; 2012128281; 2012128317; 2011127530; 2011127666; 2012010602; 2012032094; 2012042244; 2012042300; 2012053204; 2012053262; 2012064196; 2012074468; 2012074498; 2012075000; 2012085208; 2012096096; 2012106948; 2012107038; 2012107088; 2012107204; 2012107254; 2012117420; 2012128066; 2012128282; 2012031727; 2012021505; 2012021506; 2012021291; 2012021292; 2011127529; 2011127665 Class II Human Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Institute for Transplant & Research, Inc.
Biologics Cryoprecipitated AHF, Pooled 22638; 22639; 22640; 22641; 22642; 22643; 22644; 22645; 22599; 22600; 22601; 22604; 22605; 22606; 22607; 22608; 22609; 22610; 22611; 22612; 22614; 22615; 22616; 22617; 22618; 22619; 22620; 22621; 22622; 22624; 22625; 22626; 22627; 22628; 22629; 22630; 22631; 22632; 22633; 22634; 22635; 22636; 22637; 22729; 22648; 22649; 22650; 22651; 22652; 22653;  ...
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Class II Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed. American Red Cross Blood Services Heart of America Region
Biologics Cryoprecipitated AHF 40FC25610; 40FL47750; 40FL47755; 40GG25279; 40GT74300; 40GZ46302; 40K08469; 40LM12864; 40LT59262; 40LT59302; 40LT59322; 40LT59338; 40LX27007; 40LX27012; 40LZ36145 Class II Cryoprecipitated AHF, which failed to meet the minimum potency of 80IU of AHF (Factor VIII), was distributed. American Red Cross Blood Services Heart of America Region
Devices Elekta, Apex add-on Micro MLC, collimator for radiation therapy. 152652 Class II If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions. Elekta, Inc.
Devices GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Model Number : 5271997 Class II GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3. GE Healthcare, LLC
Devices VACUETTE Cellestis 1 ml QuantiFERON® - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON®-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood. Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013 Class II Cellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. Cellestis Inc
Devices Vacuette Cellestis 1 ml QuantiFERON® TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON®-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood. Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013 Class II Cellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. Cellestis Inc
Devices REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015. Class II This recall is being initiated due to the affected product being packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. Medical Components, Inc dba MedComp
Food SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600 1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13. Class II The data suggests that the formulation does not support the shelf life of the product as labeled. Aptalis Pharma Us Inc
Devices BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain. Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811. Class II A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages were identified prior to use. Baylis Medical Company Inc.
Devices Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels. Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers Class II There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012. Orthofix, Inc
Biologics Cornea CN100033OS; CN100033OD Class II Human Corneas, recovered from a donor whose donor screening was performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Indiana Lions Eye and Tissue Transplant Bank
Food GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below) 8oz = UPC Code = 33555 00325 exp 01/31/2013 and exp 02/14/2013B 16oz = UPC Code 33555 00125 exp 01/31/2013 and exp 02/14/2013B Class I Product may be contaminated with Listeria Monocytogenes GoldCoast Salads
Food GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below) 8oz = UPC Code = 33555 00234 exp 02/14/2013B 6oz = UPC Code = 33555 00124 exp 02/14/2013B Class I Product may be contaminated with Listeria Monocytogenes GoldCoast Salads
Food GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below) 8oz = UPC Code = 33555 00005 exp 02/23/13 L&S1 16oz = UPC Code = 33555 00004 exp 03/30/13 L&S1 Class I Product may be contaminated with Listeria Monocytogenes GoldCoast Salads
Food GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below) 8oz = UPC Code = 33555 00328 exp 03/10/13 S2 16oz = UPC Code 33555 00128 exp 03/10/13 S2 Class I Product may be contaminated with Listeria Monocytogenes GoldCoast Salads
Devices Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty. Reference Number Lot Number Reference Number Lot Number 01.26.10.0133: 095920, 096050, 096050A; 01.26.10.0138: 095925, 096055, 096055A; 01.26.10.0134: 095921, 096051, 096051A; 01.26.10.0139: 095926, 096056, 096056A; 01.26.10.0135: 095922, 096052, 096052A; 01.26.10.0140: 095927, 096057, 096057A; 01.26.10.0136: 095923, 096053, 096053A; 01.26.10.0141: 095928, 096058, 096058A; 01.26.10.0137: 095924, 096054, 096054A; 01.26.10.0142: 095929, 096059, 096059A. Class II Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction. Medacta Usa Inc
Devices Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets. Lot R131360 Class III Orthodontic brackets distributed was incorrectly labeled. Ultradent Products, Inc.
Devices Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. This device is not intended to sustain or support life. Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852. Class II Complaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use. Stryker Spine
Devices Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116,  ...
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Class II Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC. Oculus Innovative Sciences Inc
Drugs buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217 Lot CB1D05A, Class III Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. Actavis Pharmaceuticals
Devices KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. Tube UPC: 380040085503 Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300 Class II This product is not cleared for marketing in the US. Mc-NEIL-PPC, Inc.
Devices KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300 Class II This product is not cleared for marketing in the US. Mc-NEIL-PPC, Inc.
Devices KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc. Tube UPC: 380040088887 Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000 Class II This product is not cleared for marketing in the US. Mc-NEIL-PPC, Inc.
Food Egyptian Parsley Flakes, Weight: 10kg Net. Manufacturer's code: Batch No. 127, Lot#.: 214 Specialty Commodities' Lot numbers: SD28173, RE49421, SCS321167. Class I Specialty Commodities was notified by a customer that they had found Parsley Flakes to be positive for Salmonella. Specialty Commodities, Inc.
Food Bream Dry Salted Fish Net Wt.: about 14.2 oz Imported by Zip International Group LLC Product of Russia 835856001228; sell by 03/27/2013 Class I NYSDAM sampling and analysis has revealed that Dry Salted Fish is uneviscerated. Zip International Group
Food Organic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size: 25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner. Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in original, repacked cases, and as component of blended bulk tea products. Lot#108 Class I QTrade Teas & Herbs is recalling Organic Lemon Grass Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella. Qtrade Teas And Herb
Food Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case. Lot codes: O 262, O 263 and O 264. Class III The reason for the recall was that a small portion of the Whole Foods Market Cranberry Panettone was mispackaged in Whole Foods Market Panettone Chocolate boxes. Allergens are declared on both labels, but the only difference is that soy is in the 'may contains' statement on Whole Foods Market Cranberry Panettone box and on the Whole Foods Market Chocolate Panettone box, soy is declared in the 'contains' box. Whole Foods Market
Devices Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Product Usage: Endoscopic Instruments - For use by, or as directed by, a surgeon in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar Cable - Monopolar electrosurgical current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon. All lots distributed since 2004 Class II Integra has received complaint reports related to the electrical safety of the monopolar electrosurgical cables. Integra LifeSciences Corp.
Food Sold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages Lot code #2234 Class I Tea received from bulk supplier may be contaminated with Salmonella. Teatulia
Food Potato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490 UPC 6 54368 10038 6 and no other coding Class I The product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets. Js Pelmeni Ok, Inc.
Food Potato & Mushroom Dumplings, Net Weight 1 lb. (16 oz.), KEEP FROZEN, UPC 6 54368 10039 3 --- JS Pelmeni OK - EST # A615133 - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490 UPC 6 54368 10039 3 and no other coding Class I The product contains undeclared milk and soy based on observations found during a joint inspection by the FDA and New York State Department of Agriculture & Markets. Js Pelmeni Ok, Inc.
Food GFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg UPC 93901-10676. Distributed by Gordon Food Service, Grand Rapids, MI 49548. Lot # 3T12354C printed on the end of can Class I Undeclared Milk Allergen. GFS labeled Lemon Pudding may contain vanilla pudding which contains milk. The Lemon Pudding label does not list milk. Associated Milk Producers, Inc
Food The Muffin Mam, Inc 24oz Strawberry Crème Cake, UPC 7-60366-00986-3 All Lot Codes Class I Undeclared Allergen: Eggs. Muffin Mam Inc (The)
Food Mochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665 Product code 3F13 and 3F14 (produced January 13 and 1, 2013. Class II Koda Farms received a report from a customer that a hard yellow material was found in rice flour dough that had been manufactured using rice flour supplied by Koda Farms. The rice flour is believed to be the source of the foreign object. Koda Farms Inc
Devices The MX 16-Slice CT Scanner System can be used as a whole-body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. System Code #, 728131, Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, EP16E090010, EP16E090011, EP16E090012,EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100011, EP16E100012, EP16E100013, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100027, EP16E100028, EP16E100029, EP16E100030, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100036, EP16E100037, EP16E100038,  ...
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Class II Philips and Neusoft Medical Systems Co., Ltd. received a report from the field stating the four screws that secure the patient table top to the carrier became loose, which caused the table top to detach. Philips Medical Systems (Cleveland) Inc
Devices Ingenuity TF PET/CT Diagnostic imaging system Model # 882456, Serial # 2004. Class II Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. Philips Medical Systems (Cleveland) Inc
Devices Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226 Product Usage: Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12 Class II AIC (USA) received a notification from Aesculap, AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal. Aesculap, Inc.
Devices Technocut Plus,Sterile Single Use Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures. Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116. Class II Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Myco Medical Supplies Inc
Drugs 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 Lot 13-121-JT* * the lot number may be followed by 01 Class II Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container. Hospira Inc.
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