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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 50LH75047 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 50LH75047 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced GX88148, GX82353 Class II Blood products, collected from a donor who was taking the medication Proscar, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets 1061908, 1061928, 1061102, 1061392, 1061617, 1061619, 1061944, 1062026, 1062058, 1062063, 1063102, 1063111, 1063181, 1063183, 1063185, 1063255, 1063257, 1063460, 1063461, 1061513, 1061616, 1061700, 1061701, 1061338, 1061339, 1061343, 1061346, 1061525, 1061530, 1061533, 1061534, 1061535, 1061536, 1061622, 1061623, 1061647, 1061706, 1061707, 1061708, 1061709, 1061710, 1061711, 1061750, 1061752, 1061754, 1061755, 1061756, 1061758, 1061760, 1061761,  ...
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Class III Blood products, manufactured from Whole Blood units which may have reached an unacceptable temperature during shipment, were distributed. Aultman Hospital Blood Bank
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 50KC04629 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2922749 (2 units) Class III Blood products, which contained less than the required minimum amount of additive solution, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W117008304604 Class III Blood product, collected from an ineligible donor, was distributed. Blood Centers of the Pacific
Biologics Source Plasma 4030239848 Class II Blood product, which may have been contaminated with saline during collection, was distributed. CSL Plasma, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W117008203461 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced W117008104278 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced 7352373 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced Irradiated Washed W117008122651 Class III Blood product, labeled with an extended expiration date, was distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced W117008301235 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Centers of the Pacific
Biologics Source Plasma 07MWIH0760, 07MWIG9865 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 2809651 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Food Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case not available. Class II Wang Globalnet is recalling Surasang Chanbada Frozen Oyster IQF because it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Wang Globalnet
Food Medium Chopped Peanut Granules, Product Code #410016, packaged in 30 lb. vacuum packed plastic bags within cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes. Lot Codes subject to recall: 7029-7024-6355-6361-6356; 7130-7116, 7144-7170-7152; 7205-7201;7269-7268;7302-7303; 8002-8004;8023-8025; 8067-8066; 8135-8136; 8157-8154-8155-8148-8151; 8185-8189-8190; and 8220-8208-8214-8207-8213. Class I The recalling firm manufactured and distributed peanut products which contained peanuts and/or peanut butter which they received from there bulk peanut supplier, Peanut Corporation of America (PCA). Peanuts and peanut products produced by PCA have been implicated in a recent outbreak of salmonellosis and these product may be contaminated with Salmonella Typhimurium. Pro Nutech Inc.
Food Light Dry Roasted Unsalted Split Peanuts, Product Code: 400260, packaged in 30 lb. vacuum packed plastic bags placed inside cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes. The following Lot Codes were subject to recall: 7050; 7054; 7128; 7169; 7198; 7270; 7297-7270; 7345; 8029, 8091, 8113, 8158, 8182, 8246, 8308 and 8364. Class I The recalling firm manufactured and distributed peanut products which contained peanuts and/or peanut butter which they received from there bulk peanut supplier, Peanut Corporation of America (PCA). Peanuts and peanut products produced by PCA have been implicated in a recent outbreak of salmonellosis and these product may be contaminated with Salmonella Typhimurium. Pro Nutech Inc.
Food IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Brand, item# 20086, 40x8 oz; IQF Oysters 20 oz - Tiny, Assi Brand, item#20093, 20x20 oz. IQF Oysters 3lbs: UPC # 10081652200830, LOT # DO10921. Oyster Block: UPC # 10081652200854, LOT # DO10921. IQF Oysters 8 oz: UPC # 10081652200861, LOT # C-110304, DO11071. IQF Oysters 20 oz: UPC # 10081652200939, LOT # DO11021. Class II Korean Farm is recalling Assi Brand Korean Oysters because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. KOREAN FARM, INC.
Devices Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997. Class II Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use. Edwards Lifesciences, LLC
Biologics Recovered Plasma W128709302280 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Delta Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W128709302280 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Delta Blood Bank
Devices Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM resetting itself. If the CCM lost full functionality during bypass, the user would need to operate the pumps using the pumps' redundant controls; safety systems are not compromised. However, the user may experience distraction and/or frustration by the loss of CCM function during a case. Terumo Cardiovascular Systems Corporation
Devices Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313- 0322,1001-1027, 1100-1434, 1436, 1440, and 1441. Class II Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM resetting itself. If the CCM lost full functionality during bypass, the user would need to operate the pumps using the pumps' redundant controls; safety systems are not compromised. However, the user may experience distraction and/or frustration by the loss of CCM function during a case. Terumo Cardiovascular Systems Corporation
Devices Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Model Number 3788. All lots manufactured prior to September 20, 2010. Class II The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depleting battery voltage. Advanced Neuromodulation Systems Inc.
Devices Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. catalog number: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164. Class II Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob. Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. catalog number: 801763 and Serial numbers: 0011-0335, 0337-0610, 1001-1034,1037-1049, 1100, 1103-1106,1109-1445, and 1447-1450. Class II Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob. Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. catalog number: 801764 and Serial numbers: 0006-0066, 0100-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441. Class II Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob. Terumo Cardiovascular Systems Corporation
Devices System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage. Terumo Cardiovascular Systems Corporation
Devices System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The System 1 base includes an integrated backup battery in the event of power loss. Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage. Terumo Cardiovascular Systems Corporation
Devices AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ. Class II Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures. Encision, Inc.
Devices GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET). 261AWUSV35007H7 10026AW 514934BAR14 26329AW2 ACBCTAW7 956632AW42 321799AW1 617355AWPC1 617355AW3 361595SKW1 617754MR5AW 3454AWW 3526 941747AWW 212639XL5 239436AW2 773792AW1 803366AW1 813642AW42 973972AWW3 973972AWW5 210292AW41C 082445030001AW 082445010004AW 082421010160AW 082421120176AW 082406200003AW 082421150050AW 082416130012AW 082445150008AW 082421100265AW 082421050047AW 083049822101584 083055602101433 083055065231713 083049842101695 PT0004 PT0023 0847490042 0853550153 0853550221 AH4511AW01 030070OT02 EG1277AW01 M4017059 PC0125AW02 PC0815AW03 PC0362AW04 IE1005AW02 A5248812 A5158021 A5226504 KE1000AW01 RU2441AW02 SA1054AW01 NP083626 MP825712 FPG72503 0853550150 TN1003AW02 06056DCS01 70001ADW06 00327ADW01 58831121222 L0235B396 321mraw 420686AW01 B4192933 CC0618AW04 M27534 Class II GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to the same precision as the scanner. Assuming the two images are acquired with a calibrated machine and there is no patient movement between the CT and PET acquisitions, the two images should be visually aligned to a precision of less than one half PET voxel. However, the problem associated with this version of software may introduce a shift of up to 1.5 PET voxels, which can be as much as 8mm with certain zoom factors. GE Healthcare, LLC
Biologics Red Blood Cells Leukocytes Reduced W087912601353; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced Irradiated 09FM98338; 09GR50970; 09KG89988; Class III Blood products, labeled with an extended expiration date, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 020FN16122; Class III Blood product, collected from a donor who reported post donation illness, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 54E61210; Class II Blood products, collected from a donor whose health history screening was not adequately performed, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 54E61210; Class III Blood products, collected from a donor whose health history screening was not adequately performed, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced W036211275147; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036211167720; W036212455638; Class II Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036212455597; Class II Blood products, which was collected from a donor who traveled to malarial endemic areas, was distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036211167863; Class II Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed. Belle Bonfils Memorial Blood Center
Biologics Red Blood Cells Leukocytes Reduced W0470120514330; W0470120009030; W0470120119280; W0470121120090; Class II Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed. New York Blood Center, Inc.
Devices CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Lot numbers M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, and M840810. Class II The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. Civco Medical Instruments Inc
Devices CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Lot numbers M867430 and M873080 Class II The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. Civco Medical Instruments Inc
Devices CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Lot numbers M436540, M468460, M469640, M495160, M495190, M523420, M524580, M555880, M563330, M577940, M590400, M597880, M643870, M673080, M685650, M708280, M717280, M726110, M726130, M736410, M782740, M799860, M817860, and M840610. Class II The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. Civco Medical Instruments Inc
Devices CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Lot number M713910 Class II The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. Civco Medical Instruments Inc
Devices CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Lot numbers M493010, M493220, M708150, M710060, M783360, M803040, M803520, M808870, M823690, M832260, M840620, M848450, M855680, and M871810. Class II The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. Civco Medical Instruments Inc
Devices Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. All lots on the market of model 100 Class II There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. Atom Medical Corporation
Veterinary Solid Gold WolfCub Large Breed Puppy Food, 4lb, 15lb, and 33lb, with a best before date of December 30, 2012 and batch code starting with SGB1201A31X. Product labeling reads in part:"***LARGE-BREED PUPPY DOG FOOD***SOLID GOLD WOLFCUB***MANUFACTURED FOR: SOLID GOLD HEALTH PRODUCTS FOR PETS, INC. EL CAJON, CA 92020 NET WT 4 LBS./1.81 KG***". with a best before date of December 30, 2012 and batch code starting with SGB1201A31X. 4lb UPC 093766750005 15lb UPC 093766750012 33lb UPC 093766750029 Class I Products were produced at the facility that has been linked to recent recalls of Diamond brand pet foods due to potential Salmonella contamination. Solid Gold Hlth Prods For Pets, Inc.
Veterinary Solid Gold WolfKing Large Breed Adult Dog Food, 4lb, 15lb, and 28.5lb, with a best before date of December 30, 2012 and batch code starting with SGL1201A32X. Product labeling reads in part:"***LARGE-BREED ADULT DOG FOOD***SOLID GOLD WOLFKING***MANUFACTURED FOR: SOLID GOLD HEALTH PRODUCTS FOR PETS, INC. EL CAJON, CA 92020 NET WT 15 LBS./6.8 KG***". with a best before date of December 30, 2012 and batch code starting with SGB1201A31X. 4lb UPC 093766750005 15lb UPC 093766750012 33lb UPC 093766750029 Class I Products were produced at the facility that has been linked to recent recalls of Diamond brand pet foods due to potential Salmonella contamination. Solid Gold Hlth Prods For Pets, Inc.
Biologics Fresh Frozen Plasma W115112135149C; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W115112142979Q; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced W1151120862000; Class II Blood product, collected from a donor, for whom donor suitability was not adequately determined, was distributed. Lifesouth Community Blood Centers, Inc.
Biologics Platelets Pheresis W115112130408C; W115112130408C; W115112130408C; Class II Blood products quality control that did not meet specifications were distributed. LifeSouth Community Blood Centers, Inc.
Devices Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment. Lot Number 204889, Expiration Date March 2017 Class II Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier. Argon Medical Devices, Inc
Biologics Platelets Pheresis W126212001181; Class II Blood product, with insufficient plasma volume to support the platelet yield, was distributed. Community Blood Council of New Jersey, Inc.
Biologics Platelets Pheresis W115112123438L; Class II Blood product quality control and distribution of product that did not meet specifications was distributed. LifeSouth Community Blood Centers, Inc.
Food Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6 Catalog number: #6: UPC 771733109000; and lot numbers: 11154, 11185, 11186, 11267, 11269, 12014, 12057, 12099, 12220, and 12244. Class III The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved. H & L Jerch Sales, Inc.
Food Erosyn bottles of 30 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #7 Catalog number: #7: UPC 771733109017; and lot numbers: 11155, 11190, and 12102. Class III The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved. H & L Jerch Sales, Inc.
Food Fertalin bottles of 90 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #8 Catalog number: #8: UPC 771733109024; and lot numbers: 11157, 12103, 12221, and 12289. Class III The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved. H & L Jerch Sales, Inc.
Food Middle-Age Energy Booster bottles of 60 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #65 Catalog number: #65: UPC 771733110372; and lot numbers: 11156,12104, 12222, and 12290. Class III The products contain synthetic equivalents of spermine and/or spermidine, which are constituents or extracts of an herb or other botanical, and the that a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements. The use has not been approved. H & L Jerch Sales, Inc.
Biologics Red Blood Cells Leukocytes Reduced W071211058205; Class II Blood product, collected from a donor who traveled to a malaria endemic area, was distributed. Medic Inc
Biologics Blood and Blood Products for Reprocessing 18GL83243; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. American National Red Cross Great Lakes Region
Biologics Red Blood Cells Leukocytes Reduced W115912040222; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central California Blood Center
Biologics Red Blood Cells Leukocytes Reduced W115912230052; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Central California Blood Center
Veterinary 19% Calf Starter Medicated Active Ingredient Lasatocid Yachere 19% Calf Starter Medicated 50 Lb. Net Wt. Active Drug Ingredient Lasatocid 47.4 g/ton Yachere Feed, Inc. 415 Somerset Ave., Rockwood, PA 15557 None Class II Feed was labeled as containing Lasalocid medication. Inspection revealed product did not contain Lasalocid. Yachere Feed, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W0470120682310; W0470120682310; Class III Blood products, which were collected from a donor in which donor suitability were not adequately determined, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W041111079586K; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Blood Systems, Inc. dba United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W035212092366V; Class II Blood products, collected from a donor in which donor screening/donor records were incomplete or incorrect. Carter BloodCare
Biologics Platelets W035212092366V; Class II Blood products, collected from a donor in which donor screening/donor records were incomplete or incorrect. Carter BloodCare
Biologics Cryoprecipitated AHF, Pooled W035212096987K; Class II Blood products, collected from a donor in which donor screening/donor records were incomplete or incorrect. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035212092366V; Class III Blood products, collected from a donor in which donor screening/donor records were incomplete or incorrect. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing 011GT90390; Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced W0452122004228; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. South Bend Medical Foundation, Inc.
Biologics Red Blood Cells Leukocytes Reduced W227012005174; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W068512320619Q; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Inland Northwest Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W001312200276; Class II Blood product, which did not meet the acceptable product specifications, was distributed. Department of Air Force - BB/HT
Biologics Platelets Pheresis Leukocytes Reduced W115112158093B; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W1151121580893; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Devices Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process. Listed as Catalogue Number followed by Lot Number:  ...
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Class II Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. Stryker Howmedica Osteonics Corp.
Devices Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. Phase 1: W49604B, W49606B, W49607B, W49611B, W49612B, W49613B, W49614B, W49615B, W49616B, W49617B, W49620B, W49622B, W49623B, W49624B, W49625B, W49627B, W49628B, W49629B, W49630B, W49631B, W49633B, W49634B, W49635B, W49638B, W49639B, W50726B, W50727B, W50728B, W50731B, W50733B, W50734B, W50738B, and W50739B. Phase 2: W49609B, W49610B, W49618B, W49619B, W49626B, W49632B, W49640B, W50737B, and W50744B. Class I Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Alere San Diego, Inc.
Devices Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. Phase 1: K50514B, W49753B, W49754B, W49756B, W49757B, W49758B, W49760B, W49761B, W49762B, W49764B, W49767B, W49768B, W49769B, W49770B, W50608B, W50613B, W50621B, W50623B, W50625B, W50632B, W50634B, W50637B, W50639B, W50641B, W50642B, W51114B, and W51119B. Phase 2: W49766B, W50605B, W50627B, W50628B, and W50629B. Class I Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Alere San Diego, Inc.
Devices Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. Phase 1: K50708B, W50009B, W50011B, W50012B, W50013B, W50014B, W50016VB, W50021B, W50026B, W50028B, W50030B, W50771B, W50772B, W50773B, W50774B, W50778B, and W50801B. Phase 2: W50015B, W50029B, and W50788B. Class I Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Alere San Diego, Inc.
Devices Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). Phase 1: K50671B, W49486B, W49487B, W49489B, W49498B, W49500B, W49873B, W49890B, W49895B, W49896B, W49934B, W49947B, W49948B, W49950B, W49962B, W49968B, W50257B, W50278B, W50279B, W50282B, W50287B, W50294B, and W50313B. Phase 2: K50665B, W49855B, W49862B, W49865B, W49887B, W49892B, W49893B, W49894B, W49900B, W49933B, W49939B, W49953B, W49958B, W49960B, W49961B, W50252B, W50268B, W50273B, W50274B, W50290B, W50292B, W50295B, W50297B, W50298B, W50304B,  ...
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Class I Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Alere San Diego, Inc.
Devices Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. Phase 1: W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B. Phase 2: W50550B Class I Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Alere San Diego, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W125612607006; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Blood Bank Of San Bernardino And Riverside Counties
Biologics Source Plasma FS0240686; Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation information, was distributed. DCI Biologicals Flagstaff LLC
Biologics Red Blood Cells Leukocytes Reduced W227712320229; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mid-South Regional Blood Center
Biologics Fresh Frozen Plasma W227712320229; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mid-South Regional Blood Center
Devices Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures. Model/part Number: 90-7004, Lot Numbers: 017897 Class II Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging. PSC Industries Inc
Devices Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures. Model/part Number: 41604, Lot Number: 019737, and 021578. Class II Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm). PSC Industries Inc
Devices Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. Model/part Number: 20-1360I, Lot Number: 023399, Expiration Date: 02/28/2017. Class II Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date. PSC Industries Inc
Devices Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures Model/part Number: 20-11420, Lot Number: 023340, Expiration Date: 2/28/2017. Class II Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label. PSC Industries Inc
Devices Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. Model/part Number: 20-1360K, Lot Number: 023420,, Expiration Date: 2/28/2017. Class II Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label. PSC Industries Inc
Devices Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue. Model/part Number: 20-0431I, Lot Number: 023340, Expiration Date: 02/28/2017. Class II Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label. PSC Industries Inc
Drugs Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12. Lot # 53995 Class II Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value Noven Pharmaceuticals, Inc.
Devices IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995. Class II The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods. Philips Medical Systems (Cleveland) Inc
Devices Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Model number 881001; Serial numbers: 81172, 79937, 85083, 81097, 85145, 79916, 81132, 85011, 82020, 85007, 85006, 85081, 81028, 80914, 82004, 85041, 81180, 82016, 30019, 80910, 81133, 81098, 81169, 79940, 80980, 82036, 82007, 85084, 85085, 82039, 81127, 81165, 30003, 80818, 30007, 85042, 81184, 82021, 82030, 82023, 82051, 82026, 82024, 82028, 82050,  ...
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Class II Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that different patients have been selected. Philips Medical Systems (Cleveland) Inc
Devices InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray. IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-RC, IT35148, IT35150, IT35153P, IT35156, IT35161, IT35162P-RC, IT35164, IT35169P-RC, IT35170G-RC, IT35175, IT35182G-RC, IT35183P-RC, IT35186P, IT35187P, IT35189P, IT35192P, IT35193P, IT35194P, IT35195P, IT35200P, IT35201P, IT35207P, IT35208P, IT35209P, IT35211P-RC, IT35214P, IT35215P, IT35220P, IT35222P, IT35223P, IT35225P, IT35228P, IT35231P, IT35232P, IT35234P, IT35236P, IT35237P, IT35240P,  ...
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Class I On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues. GE OEC Medical Systems, Inc
Devices Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation. Models KKB5022-21US, serial numbers 010390894401, 010390894402, 010390894403, 010390894405, 010390894408, 010390894410, 020390958503, 030186208608, 030186208609, 030186208610, 030186208701, 030186208702, 030186208704, 030186208705, 030186208706, 030186208707, 030186208708, 030186208709, 030186208710, 030186208801, 030186208802, 030186208803, 030186208804, 030186208810, 030186208903, 040186294405, 040186453504, 040186453507, 040186453508, 040186453509, 040391134003, 040391134004, 040391134005, 040391134006, 040391134007, 040391134008, 040391134009, 050186453403, 050186453404, 050186453405, 050186453406, 050186453407, 050186453408, 050186453409, 050186453410, 050186453601,  ...
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Class II ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed. Arjo, Inc. dba ArjoHuntleigh
Devices Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation. Model KKB5060-21US, serial numbers 050186430602, 050186430608, 050186430610, 060186430704, 080186430908, 080186430909, 090186431001, 090186431002, 090186431004, 090186431006, 090186431008, 090186431009, 090186431010, 100186431102, 100186431103, 100186431104, 100186431105, 100186431106, 100186431107, 100186431108, 100186431110, 100186431207, 100186431209, 120186815003, 120186815004, 120186815006, 120186815007, 140186815107, 140186815108, 140186815109, 140186815110, 140186820201, 140186820202, 140186820204, 140186820205, 140186820207, 140186820208, 140186820209, 140186820210, 140186820301, 140186820302, 140186820303, 140186820304, 140186820305, 140186820306, 140186820308,  ...
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Class II ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed. Arjo, Inc. dba ArjoHuntleigh
Devices Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed. Models HEP0001-US, serial numbers SPSN0808U285, PN1010U507, PN1102U092, PN1102U110, SPSN0905U022, SPSN0907U048, SPSN0909U091, SPSN0605U388, SPSN0810U506, PN1102U093, PN1102U101, PN1102U112, PN1104U199, PN1104U201, PN1104U203, PN1104U214, PN1104U215, PN1104U216, PN1104U217, PN1104U220, PN1104U224, PN1104U225, PN1106U365, SPSN0804U387, SPSN0605U421, SPSN0605U423, SPSN0605U425, SPSN0605U431, SPSN0605U432, SPSN0605U440, SPSN0605U199, SPSN0605U365, SPSN0901U033, SPSN0605U206, SPSN0605U214, SPSN0605U217, SPSN0605U220, SPSN0801U071, SPSN0801U072, SPSN0707U484, SPSN0709U689, SPSN0709U692, SPSN0709U693, SPSN0710U842, P0129686, P0123033,  ...
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Class II ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed. Arjo, Inc. dba ArjoHuntleigh
Devices FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. Model Number :6677300 Serial Number : 1170 Class I A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position. Maquet Cardiovascular Us Sales, Llc
Devices Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network. Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 85068, 79932, 79943, 80911, 82019, 81027, 85049, 85043, 82008, 81119, 81089, 85108, 85026, 85146, 80994, 81021, 81182, 81017, 85067, 81161, 81164, 79936, 85103, 81147, 85110, 85082, 81179, 81035, 85046, 81031, 81129, 81004 & 85104. Class II In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements. Philips Medical Systems (Cleveland) Inc
Food Coca Cola Zero, 20 fl. oz., The Coca Cola Company. UPC 49000 04086, Optimum Taste Code; AUG062 SLA 12:52-13:44 Class II The product may exhibit off odor and off taste due to low levels of ammonium salts that may exist in these beverages. Coca-Cola Refreshments, USA Inc.
Devices Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain. 1115647, 1115939, 1120413 Class II The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure". Integra LifeSciences Corp
Food F-Tara Saikyozuke (Cod Fish with miso), 3.1lb., 20pc.x ab.2.5oz. Lot#71162 Class I The recall was initiated because Mutual Trading Co. has confirmed that Tara Saikyozuke (cod fish with miso) contains undeclared soy. Mutual Trading Company Inc
Veterinary MannaPro Chick Stick, Net Wt 15-oz (0.43 kg). Each Stick is individually packaged in a plastic wrapper. Each case contains 8/15oz-Stix. The firm name on the label is Manna Pro Products, LLC, St. Louis, MO. Lot # 031414H1, BEST IF SOLD BY 03/14/14 Class III Routine sampling of product tested positive for Salmonella. Manna Pro Corp
Devices MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086 Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7. Class II Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero. Impac Medical Systems Inc
Food Tom's Bacon Cheddar Fries, Flavored Corn and Potato Snacks, Net Wt., 2.75 oz (78.0g), Item #9980, Code Dates: Aug1712, L046B3, LO427B2, LO427B3, LO428B1, LO428B2 and LO428B3. Class II Product contains undeclared certified colors (Yellow #6, Red #40, Yellow#6 Lake, and Blue #1). Snyder's - Lance Inc.
Food Ocean Manna Korean IQF Oysters, sizes: Tiny, Medium, Large. Packed: 40x8oz, 10x2lbs, 2lbs, 6x4lbs, 10x4lbs, 30x1lb, 6x5lbs. Item Code: FO/HMART-2LB, FO/HMART-1LB, FO/HMART-8OZ, FO/HMART-5LB, FO/HS-OHS144, FO/LP-OL6X4, FO/HS-0L4, FO/KO-OM4, FO/HS-OM4, FO/LP-OS8, FO/HS-OT8, HS-0B2. Lot Code: C-110427, C-110428, C-110420, C-110419, C-110317, C-110426, C-110411, C-110412, C-110413, C-110330, C-110331, C-110402, C-110415, C-110416, C-110418, C-110421, C-110425, C-110428, C-110429, C-110216, C-110225, C-110214, C-110221, C-110226, C-110307, C110308, C-110225, C-110305, C-110216, C-110214, C-110212, C-110215, C-110115, C-110211, C-110213, C-100428, C-110114. C-110112, C-110113, C-100426, C-100428, C-100511, C-100513, C-100514, C-100516, C-100517, C-100424, C-100323,  ...
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Class II Pacific Giant is recalling all frozen (IQF) oyster meat and 1/2 shell oysters from South Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Pacific Giant, Inc
Food Maryland Style Crab Soup 2340 Net Weight 4-4LBS. Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350 Lot #872, expiration 06/29/12 Lot #879 expiration date 07/06/12 lot #888 expiration date 07/15/12 Class II Possible processing temperature issue that occurred during the production of Seafood Soups Winter Gardens Quality Foods Inc
Food FF Cream of Crab Soup 3109 Net Weight 4-4 LB. Keep Refrigerated Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350 Lot #864 Exp. Date 6/21/12 Lot #867 Exp Date 6/24/12 Lot #874 Exp Date 07/01/12 Lot #888 Exp Date 7/15/12 Class II Possible processing temperature issue that occurred during the production of Seafood Soups Winter Gardens Quality Foods Inc
Food Lobster Bisque 3107 Net Weight 4-4 LBS. Keep Refrigerated Packed By Winter Garden Quality Foods, Inc. 304 Commerce St., New Oxford, PA 17350 Lot #859 Exp Date 6/16/2012 Lot #871 Exp Date 06/28/12 Lot #879 Exp Date 07/06/12 Class II Possible processing temperature issue that occurred during the production of Seafood Soups Winter Gardens Quality Foods Inc
Food New England Clam Chowder 2338 Net Weight 4-4LBS. KEEP REFRIGERATED Packed by Winter Garden Quality Foods, Inc. 304 Commerce St, New Oxford, PA New Oxford, PA 17350 Lot #859 Exp Date 6/16/2012 Lot #878 Exp Date 0/05/12 Class II Possible processing temperature issue that occurred during the production of Seafood Soups Winter Gardens Quality Foods Inc
Devices iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 FUSO Analyzer 300F 310003 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 i-Stat1 Abaxis Analyzer 6000-0000 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Military Kit iStat1 04J48-201 215001 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Military Kit Portable Clinical Analyzer 04J48-01 215000 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Abbott Point Of Care Inc.
Devices Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique); Part numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY Class II Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. Zimmer, Inc.
Devices Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine. Part numbers 3573-2 (straight handle) all lots. Class II Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. Zimmer, Inc.
Food T.G.I. Friday's Mozzarella Sticks 2.25oz, 3.5oz, and 4.8 oz. Item#30187, 30588, 30588B, 30707, 30819, 30834. Lot # FEB242013 Class II Inventure Foods Inc. is recalling mozzarella sticks and onion rings because there may be a chance that there are tiny metal particles in their seasoning. Inventure Foods
Food Onion Rings, 2 oz, 3oz., 6.53 oz & 13 oz.. Burger King Brand, item#41016, 41105, 41121. T.G.I.F Brand, item#41130, 30587, 30587B, 30614, 30845A, 31124, 31125. Lot # FEB162013, FEB172013, 2013MA22, 2013MA23, FEB122013 Class II Inventure Foods Inc. is recalling mozzarella sticks and onion rings because there may be a chance that there are tiny metal particles in their seasoning. Inventure Foods
Food Kit item #30699-76, includes Mozzarella Sticks, 2.25 oz, 12bags/kit; Cheddar Bacon Skins, 3oz, 24 bags/kit; and Sour Cream & Onion Skins 3oz, 12bags/kit. kit item#30679-11, 30679-12, and 30679-13, includes Mozzarella Sticks 2.25oz, 12bags/kit, Cheddar bacon skins 3oz, 24 bags/kit, and Sour Cream & Onion skins 3oz, 12bags/kit. Kit Item#30845-A- Onion Ring Clip Strip, 2oz, 24 bag/clip strip. Lot # FEB242013, FEB232014, FEB1713 Class II Inventure Foods Inc. is recalling mozzarella sticks and onion rings because there may be a chance that there are tiny metal particles in their seasoning. Inventure Foods
Devices Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures. Model Number: 75820, Lot Number: 019632 Class II The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils. PSC Industries Inc
Devices Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures. Model Number: 75800, Lot Numbers: 023392 and 022438 Class II The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils. PSC Industries Inc
Food Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435*** Product of S Korea*** Batch codes: 29780 29737 27982 27988 27591 27592 27593 27594 27595 27173 Class II Distributed oysters were harvested from waters in South Korea, from which products had been prepared, packed, or held under insanitary conditions or where it may have become contaminated with filth, or where it may have been rendered injurious to health. Wanchese Fish Company
Food Oysters, IQF Select, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435***Product of S Korea*** Batch codes: 29734 29737 29437 29438 29254 28973 28964 28965 28966 28790 28791 28792 28782 28788 28789 28644 28393 28394 28395 27982 27988 27673 27680 27550 27549 27151 27074 27111 27112 27113 27068 27069 27070 Class II Distributed oysters were harvested from waters in South Korea, from which products had been prepared, packed, or held under insanitary conditions or where it may have become contaminated with filth, or where it may have been rendered injurious to health. Wanchese Fish Company
Food Oysters, Breaded IQF, 20-25 count, packed in 2 lb polyethylene bags, 5 bags/carton, and labeled in part ***Wanchese Fish Company, 2000 Northgate Commerce Parkway Suffolk, VA 23435***Product of S Korea*** Batch: 27585 27586 27587 27588 27589 Class II Distributed oysters were harvested from waters in South Korea, from which products had been prepared, packed, or held under insanitary conditions or where it may have become contaminated with filth, or where it may have been rendered injurious to health. Wanchese Fish Company
Devices Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952 Class II Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Philips Healthcare Inc.
Food Sienna Bakery® White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY LECITHIN ADDED AS EMULSIFIER, VANILLA EXTRACT), BROWN SUGAR, WHITE SUGAR, WHITE CHUNK ( SUGAR, PARTIALLY HYDROGENATED PALM KERNEL AND PALM OILS, NONFAT DRY MILK, BUTTERFAT, SOY LECITHIN, ADDED AS EMULSIFIER, SALT AND ARTIFICIAL FLAVORING ADDED) BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), M ACADEMIA NUTS, INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) , SALT, SODA BICARBONATE, CARMEL COLOR.), CONTAINS: WHEAT, MILK, EGG TREE NUT (MACADAMIA), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548 121222061052009, 121222061052001 on the master case, 12122201 on the retail box. Class II Best Maid Cookie Company is voluntarily recalling Sienna Bakery® Oatmeal Walnut Raisin and Sienna Bakery® White Chocolate Macadamia Nut cookies due to a potential mis-pack, resulting in an undeclared allergen. Oatmeal Walnut Raisin cookies may have been inadvertently packed in White Chocolate Macadamia Nut retail boxes. Oatmeal Walnut Raisin cookies contain walnuts which are NOT declared on the White Chocolate Macadamia Nut packaging. Minnesota Best Maid Cookie Co, Inc.
Food Sienna Bakery® Oatmeal Walnut Raisin Gourmet Cookies, UPC 093901165992, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, RAISINS, BROWN SUGAR, OATS, WALNUTS, BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) CINNAMON, SODA BICARBONATE, SALT, CARMEL COLOR.), CONTAINS: MILK, EGG TREE NUT (WALNUT), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548 121222011525001 on the master case, 12122201 on the retail box. Class II Best Maid Cookie Company is voluntarily recalling Sienna Bakery® Oatmeal Walnut Raisin and Sienna Bakery® White Chocolate Macadamia Nut cookies due to a potential mis-pack, resulting in an undeclared allergen. Oatmeal Walnut Raisin cookies may have been inadvertently packed in White Chocolate Macadamia Nut retail boxes. Oatmeal Walnut Raisin cookies contain walnuts which are NOT declared on the White Chocolate Macadamia Nut packaging. Minnesota Best Maid Cookie Co, Inc.
Devices Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. All serial/lot numbers Class II The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions. Stryker Endoscopy
Food Jimmy Peppers Hot Cherry Sliced Peppers, 1 gallon plastic jars Lots: CH 2350, Best By Date 9/10/12; CH 2550, Best By Date 9/12/12 Class II Product contains foreign material Cosmo's Food Products, Inc.
Food Sprouts, Soybean, packed in clear plastic 1.0 lb and 1.5 lb. bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580*** and also bulk packaged in unlabeled 10 lb black plastic bags. Products are not coded Class I Soybean sprouts may be contaminated with Listeria monocytogenes. Henrys Farm Inc.
Food Sprouts, Natto Soybean, packed in clear plastic 1.0 lb bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580*** Products are not coded Class I Soybean sprouts may be contaminated with Listeria monocytogenes. Henrys Farm Inc.
Devices System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. In this situation, the potential for patient injury depends on the patient condition, the user's response to the malfunction, the criticality of the pump that is impacted (arterial, cardioplegia, sucker, vent) and the timing of the event (before, during, or after cardiopulmonary bypass) The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. Terumo Cardiovascular Systems Corporation
Devices System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and1441. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. In this situation, the potential for patient injury depends on the patient condition, the user's response to the malfunction, the criticality of the pump that is impacted (arterial, cardioplegia, sucker, vent) and the timing of the event (before, during, or after cardiopulmonary bypass) The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. Terumo Cardiovascular Systems Corporation
Devices System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106,1109-1445, and 1447-1450. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. Terumo Cardiovascular Systems Corporation
Devices System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and 1441. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. Terumo Cardiovascular Systems Corporation
Food Product is labeled in part: "***LEASA Living Alfalfa Sprouts***CHOLESTEROL FREE***PRESERVATIVE FREE***KEEP REFRIGERATED***NET WT. 6 OZ. (168 g)***" Product is packaged in 6 oz clear plastic containers with UPC 75465-55912. UPC Code and expiration date are located on the side of the container. Use by Date: 07/02/2012 Class I LEASA Industries Co., Inc. initiated a recall of 6 OZ containers of LEASA Living Alfalfa Sprouts with Use By Date 07/02/2012, UPC 75465-55912 after being informed by the Florida Department of Agriculture and Consumer Safety that a product sample had tested positive for Salmonella. LEASA Industries Co., Inc.
Food Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company. UPC 49000 04754, Optimum Taste Code: SEP0312LWC Class II Product is misbranded. Label indicates sugar free, however the product is actually sugar sweetened Coca Cola Cherry. Coca-Cola Refreshments USA, Inc.
Devices superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use. S030097 S0030044 S030065 S030092 S030579 S420011 S420102 I4202008 S0030045 S030066 S030092 S030586 S420012 S420105 I4202012 S00312 S030067 S030094 S030587 S420013 S420107 S0030011 S030043 S030069 S030096 S030588 S420015 S420108 S0030013 S030046 S030070 S030098 S030604 S420019 S420109 S0030014 S030049 S030072 S030099 S030605 S420020 S420110 S0030015 S030052 S030075 S030102 S030608 S420021 S420112 S0030017 S030054 S030076 S030105 S030609 S420026 S420114 S0030021 S030056  ...
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Class II superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide, and then generates an error message. superDimension, Inc
Devices Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE® 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE® 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments All serial numbers Class II HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable Smiths Medical ASD, Inc.
Drugs Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18 Lot #0ZP5128 exp; 8/2013 Class II Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets. GlaxoSmithKline Inc
Food Kroger Fresh Selections Greener Supreme; Iceberg lettuce, Romaine lettuce, Carrots and Red Cabbage; 12 oz plastic bag. Best if used by date: June 19, 2012: UPC 0 11110 91039 4 Distributed by the Kroger Co., Cincinnati, OH 45202 N158 211B 1613 KR04 Class I Positive MDP sample for Listeria Monocytogenes collected b USDA for Marketside Leafy Romaine Salad with Best By date of June 19, 2012. Dole Fresh Vegetables Inc
Food Leafy Romaine; Romaine Lettuce & Leaf Lettuces; 10 oz plastic bag. Best if used by date: June 19, 2012. Packaged under brand names of: Kroger Fresh Selections, UPC 0 11110 91046 2, Distributed by the Kroger Co., Cincinnati, OH 45202 and Marketside UPC: 6 81131 02781 6 Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 Kroger code: N158 111B KR11; Marketside code: N158111B Class I Positive MDP sample for Listeria Monocytogenes collected b USDA for Marketside Leafy Romaine Salad with Best By date of June 19, 2012. Dole Fresh Vegetables Inc
Devices The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required. SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549, Class II GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard. GE OEC Medical Systems, Inc
Drugs Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16. Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13. Class II Impurities/Degradation Products: exceeded specification at 3 month stability testing VistaPharm, Inc.
Devices CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. Lot s: 59887, 59888, 61516, and 61517. Class II CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft. Cardiovascular Systems, Inc.
Food Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag; Item number: 154205 Giusto's 344 Littlefield Ave. South Francisco, CA 94080 Lot numbers 10682, 11142 Class II Firm was notified by supplier that Wheat germ product is contaminated with metal fragments, approximately 0.5mm in diameter and range 3-15mm in length. Giusto's Specialty Foods LLC
Drugs Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13 Class II Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. Kimberly-Clark Corporation
Drugs Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 a) SKU 34136-00; Lot #: SA2137SLA, SA2136SLB, Exp 05/13, SA2060SLB, Exp 02/14, SA2076SLB, SA2086SLC, SA2087SLA Exp 03/14, SA2131SLA, SA2135SLA, Exp 05/14 b) SKU 34135-00; Lot #: SA2086SLB, Exp 03/14 c) SKU 34111-00; Lot #: SA2086SLA, Exp 03/14, SA2122SLA, SA2123SLA, Exp 04/14 Class II Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. Kimberly-Clark Corporation
Food Banner Mountain Sprouts;Alfalfa Sprouts; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; 1 lb and 2 lb packages. Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9691172842 3; UPC 1 lb size: 0 96911 72850 8 Sell By dates of 6/17/12 to 7/6/2012. Class I USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts. Banner Mountain Sprouts Inc
Food Banner Mountain Sprouts;Alfalfa Broccoli Sprouts; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9691172840 9; Sell By dates of 6/17/12 to 7/6/2012. Class I USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts. Banner Mountain Sprouts Inc
Food Banner Mountain Sprouts;Zesty Greens - Clover, Radish; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 96911 72845 4; Sell By dates of 6/17/12 to 7/6/2012. Class I USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts. Banner Mountain Sprouts Inc
Food Banner Mountain Sprouts; Sprout Salad: Alfalfa, Peas, Garbanzo, Adzuki, Lentil, Clover, Radish; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 96911 72846 1; Sell By dates of 6/17/12 to 7/6/2012. Class I USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts. Banner Mountain Sprouts Inc
Food Banner Mountain Sprouts; Clover Sprouts: California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz and 1 lb containers; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 96911 72843 0; UPC - 1 lb size: 0 96911 72851 5. Sell By dates of 6/17/12 to 7/6/2012. Class I USDA MDP Sampling found a positive result for Salmonella in Alfalfa Sprouts grown by Banner Mountain Sprouts. Banner Mountain Sprouts Inc
Devices Focal SIM Planning of radiation therapy Version 4.64.00 - 4.700, inclusive Class II Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. Elekta, Inc.
Devices Monaco Product Usage: Planning of radiation therapy Version 3.10.00 - 3.20.00, inclusive Class II Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. Elekta, Inc.
Drugs Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0. Lot #: H008328, Exp 11/14 Class III Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules. ASTRA ZENECA Lp
Devices enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. a) 510(k): K060537 b) Medical device listing number: D071942 All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products: Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103 Class II The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours. Vital Signs Devices, a GE Healthcare Company
Food Dole brand Hearts of Romaine; Net Wt. 10 oz. UPC 71430 00956; Dole Product number 0540 Code number N165112A Enjoy by 06/26/2012. Class I IEH sample of Dole's Hearts of Romaine was positive for Listeria Monocytogenes. Dole Fresh Vegetables Inc
Devices Drager PT 4000 Phototherapy System Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025. Class II A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not been any reports received from the field of such cases occurring, or any injury or harm being suffered in connection with this issue. Draeger Medical Systems, Inc.
Food Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:" Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI POPS 15418 CORNET SANTA FE SPRINGS, CA 90670 PLANT NO. 06-4562***". UPC 763734 000011 Class I The firm initiated the recall because the product may contain egg yolk. Fruiti Pops Inc.
Food Clams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996. Product is not date coded. Class II Frozen clams, product of S. Korea, may be contaminated with Norovirus. Rhee Brothers Incorporated
Drugs HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7. Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13 Class III Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Food Romaine Lettuce tied with a rubber band There are no codes on the product. Sold on July 2 or 3, 2012, Class I Positive field test for Salmonella. Pacific International Marketing
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