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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 368010172 Class III Blood product, collected from a donor whose arm check and general appearance inspection were not documented, was distributed. International BioResources, LLC
Biologics Red Blood Cells Leukocytes Reduced GP30924 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Blood and Blood Products for Reprocessing GP30924 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced 50LH79006 Class III Blood products, which should have been quarantined pending an investigation, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 4035495 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced 103043006 Class III Blood product, possibly contaminated with P.acne, was distributed. Blood Systems, Inc.
Biologics Red Blood Cells 3051339 Class II Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Red Blood Cells Leukocytes Reduced 5082472; 3052917 Class II Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Fresh Frozen Plasma 3051339; 5082472; 3052917 Class II Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed. HemaCare Corporation
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 101976580; 101976580 Class II Blood products, collected from a donor taking the drug Avodart, were distributed. Blood Systems, Inc.
Biologics Blood and blood products for reprocessing W070008001819 Class III Blood products, collected from a donor who was previously deferred, were distributed. Childrens Hospital Los Angeles
Biologics Source Plasma 07KPT16024; 07KPT15990 Class II Blood products which tested negative for all viral markers, were collected from a donor who subsequently tested positive for hepatitis C (HCV) by NAT. BioLife Plasma Service, LP
Biologics Red Blood Cells 01KG99432, 01KG99431, 01KG99434, 01KG99435, 01KG99438, 01KG99460, 01KG99447, 01KG99445, 01KG99458, 01KG99453, 01KG99457, 01KG99451, 01KG99441, 01KG99456, 01KG99433, 01KG99436, 01GE72762, 01GE72764, 01GE72763, 01FM61959;01FM61955;01FM61962;01FM61968;01FM61970;01FM61960;01FM61963;01FM61965;01FM61966;01FM61971;01FM61972 Class III Blood products, for which the West Nile Viral testing performed was incomplete, were distributed. American National Red Cross (The)
Biologics Red Blood Leukocytes Reduced 01GH15013, 01GH15012, 01GQ29464, 01GQ29427, 01GQ29454, 1GQ29460, 01GQ29461, 01GQ29463, 01GQ29465, 01GQ29467, 01GQ29469, 1GQ29474, 01GQ29453, 01GQ29458, 01GQ29468, 01KT32514, 01KT32524, 01KT32520, 01KT32524, 01KT32539, 01KT32530, 01KT32546, 01KT32536, 01KT32538, 01KT32543, 01KT32547, 01KT32541, 01KT325519, 01KT32544, 01KT32521, 01KT32528, 01KT32532, 01KT32522, 01FM62000, 01FM61998, 01GE72771, 01GT29616, 01GT29609, 01GT29610, 01GT29613, 01GT29614, 01GT29615, 01GT29590, 01KM53768, 01KM53770, 01KM53766, 01KM53776, 01KM53761, 01KM53764, 01KM53765,  ...
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Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 01GQ29427 bag1 & bag2, 01GQ29429 bag 1 & bag2, 01GQ29430 bag2 , 01KG99421 bag1, 01KG99425 bag1, 01KG99422 bag1, 01KG99420 bag1, 01KG99423 bag1 & bag2, 01KG99424 bag 1 & bag 2, 01GQ29434 bag1, 01GQ29426 bag1 & bag2, 01GQ29435 bag1, and 01GQ29436 bag1 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 01GT29616 , 01GT29611 , 01GT29462 , 01GT29617 , 01GT29607, 01GQ29457 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 01W51941 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours (FP24) 01KG99436, 01KG99447, 01KG99458, 01KG99446, 01KG99460, 01KT32538, 01KT32537, 01KT32524, 01KT32522, 01KT32546, 01KT32541, 01KT32511, 01KT32553, 01KT32518, 01KT32530, 01GE72773, 01GE72771, 01GE72769, 01FM61970, 01FM61967, 01FM61966, 01FM61963, 01FM62201, 01FM62202, 01FM61961, 01FM61665, 01FM61972, 01FM61997, 01FM61998, 01FM62000, 01FM62205, 01FM61965, 01FM61968, 01GH15015, 01GH15014, 01GQ29463, 01GQ29461, 01GQ29467, 01GQ29469, 01GQ29451, 01GT29591, 1GT29612, 01GH15018 Class III Blood products, for which West Nile Viral testing was incomplete, were distributed. American National Red Cross (The)
Biologics Red Blood Cells W044208304007 Class II Blood products, collected from a donor for whom hemoglobin screening test was not performed, were distributed. San Diego Blood Bank
Biologics Red Blood Cells Leukocytes Reduced KS31583; KS32243; KS32648; GF62856; KS26788; KS26831; KS26878; KS26880; KS26895; KS27908; KS27987; KS30757; KS32556 Class II Blood products, possibly contaminated with air during collection, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells KS32438; KS32530; KS32527; KX17484; KX17483; KX17479; KX17475; KX17468; KX17467; KX17464; KS32596; KS32597; KS32598; KS32601; KS32610; KS32595; KS32604; KS32629; KS32628; KS32626; KS32624; KS32621; KS32643; KS32632; KS32642; KS32552; KS32528; KS32553; KS32658; KX17465; KX17470; KS32638; KS32582; KS32607; KS32654; FG12509; KS32635; KS32531; KS32604; KS32610; KS32519; KS32643; KX17454; KX17457; KX17461 Class II Blood products, possibly contaminated with air during collection, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen KS26450; KS32618; KS26812 ;KS26795; KS27370; KS27371; KS27883; KS30126 ;KS26778; KS26831; KS31365; KS30245; KS26824; KS31331; KS26776; KS26787; KS26788 ;KS26791; KS26850; KS26852; FG10087; KS32472; KS32625 Class II Blood products, possibly contaminated with air during collection, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen Cryo Reduced KS31255; FZ85831; KS31581; KS32483; KS32655; KS36252; KS32652; KS32538; KS32530; KS32547; FX20623; KS28912; KS29917; KS32635; KS27597; KS27917; FX20723; KS28903; KS30221; KS30217; FZ85566; KS31545; KS31543; KS31553; KS30131; KS32532; KS32597; KS31562; KS31546; KS32253; KS31860; KS31557; KS31651; KS32255; KS30140; KS30222; FZ85830; KS31238 Class II Blood products, possibly contaminated with air during collection, were distributed. American Red Cross Blood Services
Biologics Cryoprecipitated AHF FZ85867; KS31542; KS31546; KS31548; KS29887; KS31562; KS29999; KS29996; KS30008; KS30162; KS32397; KS32434; KS32442; FZ85860; KS32453; KS32476; KS32495; KS32439; KS32456; KS32455; KS32448; KS32457; KS32608; FX20688; FX20623; FX20672; FX20739; KS27597; KS27618; KS27604; KS27609; GJ87542; KS27803; KS27919; KS27989; KS27987; FG07159; FG07161; KS30000; KS30214; KS30217; KS30819; KS31047; GG54598; GG54596; KS32653; KS31129; KS32680; KS32657; KS27376;  ...
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Class II Blood products, possibly contaminated with air during collection, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced W313711006151; W313711006151; W313711006151; W313711007011; W313711007011 Class II Blood products, collected from donors who reported travel to malarial endemic areas, were distributed. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W313711006529; W313711006529; W313711006529; W313711006773; W313711006773; W313711006773. Class II Blood products, collected from donors who reported travel to malarial endemic areas, were distributed. HemaCare Corporation
Biologics Red Blood Cells Leukocytes Reduced W313711135113; W313711118495; W313711124899; W313711125072. Class II Blood products, collected from donors who reported travel to malarial endemic areas, were distributed. HemaCare Corporation
Devices Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants. Part number 03.809.690, Lot Number 6723847 Class II This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use. Synthes USA HQ, Inc.
Devices Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Part Number 241.267, lot number 8037923 Class II Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). Synthes USA HQ, Inc.
Devices Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position. The following Joystick model numbers and respective part numbers are affected by this recall: CSPJ, 1121239; SPJPLUS, 1127291; SPJAP, 1136937; SPJAPM, 1136938; CMPJM6, 1164361; CMPM6U, 1644361; MPJM6, 1136885; MPJM6U, 1136885; 1558M6, 1136887; 1558MM6, 1136887; 1500M6, 1136889; PACM6, 1136888; PACM6, 1167927;  ...
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Class II Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks. Invacare Corporation
Biologics Red Blood Cells Leukocytes Reduced W041112066647F; W041112054611T Class II Blood products, collected from a donor who traveled to a malaria endemic area, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Red Blood Cells W036809267543 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036809818928 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036809267543 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036811019372 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036811019372 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2077018 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets 2077018 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W085313001566-part 1; W085313001566-part 2 Class II Blood products, which did not meet the acceptable product specifications, were distributed. Central Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W288613000541; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced W067113050945; Class III Blood product, labeled with an incorrect expiration date and product code, was distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells W067113021623; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. The Blood Center
Biologics Fresh Frozen Plasma W067113021623; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. The Blood Center
Biologics Platelets W067113021623; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. The Blood Center
Biologics Red Blood Cells Leukocytes Reduced W117008118113; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Blood and Blood Products for Reprocessing W117008118113; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Cryoprecipitated AHF 2642211; W036808137145; W036809172740; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Leukocytes Reduced W036809154256; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036808137145; W036809172740; W036809154256; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036809154256; W036809154710; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2642211; W036808137145; W036809172740; W036810117211; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036809819555; W036810813443; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036809154710; W036810117211; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036513027187; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. LifeShare Blood Centers
Biologics Fresh Frozen Plasma W036513027187; Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. LifeShare Blood Centers
Biologics Source Plasma TQ215673; TQ213787; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Knoxville Plasma Corporation
Biologics Red Blood Cells W045613002185; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Bank of Erie County
Biologics Platelets Pheresis Leukocytes Reduced W204013801547A; W204013801547B; W204013801539; W204013801551A; W204013801551B; W204013801551C; Class II Blood products, which did not meet the acceptable product specifications, were distributed. American Red Cross Blood Services Heart of America Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W204013801543; Class II Blood products, which did not meet the acceptable product specifications, were distributed. American Red Cross Blood Services Heart of America Region
Devices DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result. Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14. Class II Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. Microgenics Corp
Drugs Pyridostigmine Bromide Tablets, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10 109497; Exp. 12/15 Class II Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing. Core Pharma Llc
Devices The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. Model Numbers: FL23SE with nurse call option: OL235017 & OL235018 List of Affected Devices: J60267 J60425 J60009 J60001 J60094 J60095 J60096 J60348 J60349 J60350 J60351 J60352 J60353 J60354 J60360 J60361 J60362 J60363 J60364 J60365 J60366 J60367 J60368 J60369 J60370 J60371 J60372 J60373 J60374 J60375 J60376 J60377 J60378 J60379 J60380 J60381 J60382 J60383 J60384 J60385 J60386 J60387 J60388 J60389 J60390 J60391 J60392 J60393 J60394 J60395 J60396 J60397 J60398 J60399 J60400 J60401 J60402 J60403 J60404 J60405 J60512 Class II The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged. Stryker Medical Division of Stryker Corporation
Devices Terumo® Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo® Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo® Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours. Recalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07,  ...
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Class II Medical device used in cardiovascular procedures is defective. Terumo Cardiovascular Systems Corporation
Devices GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 00000173038MR1 00000136104MR7 00000264553MR9 00000265096MR8 00000005532YR7 00000007097YR9 00000007556YR4 00000281841MR7 00000289583MR7 0000SGH919066P 00000013883YR4 0000SGH231PPQK 00002UA2050JKX 00002UA2400LWP 00002UA24315PT 00002UA24315PY 00002UA24315P5 00002UA24907W7 00000266797MRO 00000267189MR0 00000270550MR7 00000283466MR1 00000305180MR2 00000306054MR8 0000267533MR8A Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct. The issue may result in an incorrect diagnosis from the study with mixed patient data, if the series protocol and anatomy on the studies are similar, and the annotation is not noticed. GE Healthcare, LLC
Devices Monaco RTP System Radiation treatment planning Versions 3.10.00 and later Class II Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. Elekta, Inc.
Devices Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning. All versions of Monaco Class II Patient needs to be positioned as indicated by the treatment plan. Elekta, Inc.
Devices QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974 Class II The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector. Maquet Cardiovascular Us Sales, Llc
Devices TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts Class 1 exempt Device Listing #D122038 Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0 Secondary 19" touchscreen - part number 1707.05A0 The above product is affected only when used in combination with Tegris base system 1703.01X0 OR Table Control 1703.71A0 Class II MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System. Maquet Cardiovascular Us Sales, Llc
Devices ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery. Item: 346VA; Lot Numbers: D3, E3, F3 Class II Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Endoplus, Inc.
Devices ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery. Item: 345VA; Lot Number: F3 Class II Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Endoplus, Inc.
Devices BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space. 510K K925902 D041521 Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226 0291227 0291228 0336391 0336393 0336396 0336400 1005321 1006136 1033177 1033178 1094304 1209634 1210646 1213990 1213993 1276782 1307383 2032802 2033712 2060835 2065940 2084318 2121011 2122467 2205098 2212313 2276066 3038272 3042376 3063436 3063440 3085498 3085001 3085003 3085005 3123462 3123246 3184092 Catalog Number 405291 Lots 0154661 0174905 0252565 0279140 0301813 0347866 1012200 1035046 1063738 1095340 1124755 1180073 1213029 1262268 1273795 1312116 1320204 1356378 2041210 2058524 2083246 2135469 2158092 2170207 2194139 2205106 2223162 2223337 2250088 2286395 2303137 2303141 2334338 2334339 2355389 2355391 3057376 3120039 Catalog Number 405807 Lots GD873422 GD874743 GD875419 GD876029 GD876912 GD879577 GD881128 GD883033 Catalog Number 405823 Lots GD877068 GD882951 GD884312 GD885491 GD886192 GD887893 GD889527 B01F223D B01F243D B01G057D B01G196D Catalog Number 406078; Lots GD876003 GD877787 GD881169 GD883017 GD883660 GD885202 GD886283 GD888677 GD890442 B01F054D B02F156D B02F178D B03F074D B03F241D Catalog number 406084 Lots B03F090D B06F326D GD875369 GD880427 GD883025 GD888255 B05G087D Catalog # 406119 Lots GD873364 GD875625 GD877878 GD879015 GD881813 GD885129 GD889782 B02F051D B02F096D B01F135D B03F222D Catalog # 406121 Lots GD887596 GD889618 Catalog # 406156 Lots GD887778 GD889733 GD889980 GD890178 B02F214D B02F292D B02G157D B03F292D B03G158D B04F238D B05F241D Class II BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space. Becton Dickinson & Company
Food Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS Lot Code: 6483004 Class II Packages of breaded shrimp failed to declare shellfish (shrimp) and wheat allergens. Gourmet Express Marketing, Inc.
Food Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010 Best Buy or Sell By date prior to October 19 Class II Inadequate pasteurization Blythedale Farm Inc.
Food Blythedale Farm Farmstead Brie, 1 lb white wrapped disc UPC Code: Best Buy or Sell By date prior to October 19 Class II Inadequate pasteurization Blythedale Farm Inc.
Food Blythedale Farm Camembert Vermont, 7 oz wrapped disc in plastic cup UPC Code: 762713669027 Best Buy or Sell By date prior to October 19 Class II Inadequate pasteurization Blythedale Farm Inc.
Devices SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors. Lot Number 13016314 Class II CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead. CareFusion 303, Inc.
Devices SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. Lot Numbers 13015883 and 13025342. Class II CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. CareFusion 303, Inc.
Devices CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing. Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672. Class II CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years. CareFusion 303, Inc.
Food spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320. Use by 09/06/13/04 Class I One lot of Spartan Fresh Selections American Potato Salad has the potential to be contaminated with Listeria monocytogenes. Garden-Fresh Foods, Inc.
Food Pecan Brittle's label is read in parts: "***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***". firm did not provide Class II Finished product labels declared butter or cream but milk is not listed. Snoqualmie Falls Candy Factory, LLC
Food Almond Brittle's label is read in parts:"***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***". firm did not provide Class II Finished product labels declared butter or cream but milk is not listed. Snoqualmie Falls Candy Factory, LLC
Food Coconut Peanut Brittle's label is read in parts:"***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***". firm did not provide Class II Finished product labels declared butter or cream but milk is not listed. Snoqualmie Falls Candy Factory, LLC
Food Coconut Brittle's is labeled in parts: "***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, butter (cream, salt), vanilla, salt***". firm did not provide Class II Finished product labels declared butter or cream but milk is not listed. Snoqualmie Falls Candy Factory, LLC
Food Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128 Batch number SC1308067; 001-071, Expiry 2/2/14 Class II Human Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test. Mothers Milk Bank
Devices ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis. Lot/Serial #(s): 014664503 Class III HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent. Horiba Instruments, Inc dba Horiba Medical
Devices Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life. Model number 0240-095-200, all serial numbers. Class II When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient. Stryker Endoscopy
Food First Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4 Lot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142,  ...
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Class I Bubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy. KDK Management, Inc., dba Bubbles Baking Co.
Food First Street Blueberry Muffins Loaf (S 45383), 16 oz., 12 trays/case, UPC 0 41512 10854 9. Lot Codes: 12355, 12361, 12365, 12365, 13013, 13007, 13008, 13022, 13029, 13030, 13031, 13001, 13032, 13038, 13039, 13042, 13049, 13050, 13051, 13058, 13059, 13063, 13064, 13070, 13073, 13079, 13084, 13085, 13086, 13091, 13093, 13094, 13098, 13099, 13102, 13105, 13107, 13114, 13115, 13116, 13122, 13123, 13124, 13128, 13129, 13130, 13134, 13140, 13142,  ...
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Class I Bubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy. KDK Management, Inc., dba Bubbles Baking Co.
Devices Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH® and PORT-A-CATH® II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein. 1991524 1997100 2033224 2051222 2116286 2183921 2192487 2210967 2229821 2237453 Class II Smiths Medical is conducting a voluntary recall of PORT-A-CATH® and PORT-A-CATH® II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue. Smiths Medical ASD, Inc.
Devices Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH® and PORT-A-CATH® II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein. 21-8011-24: 1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695 21-8052-24: 1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158 21-8053-24: 2168989 2249697 Class II Smiths Medical is conducting a voluntary recall of PORT-A-CATH® and PORT-A-CATH® II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports of serious injury or death related to this issue. Smiths Medical ASD, Inc.
Devices Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices. Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002 Class II The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle. Steris Corporation
Food JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and blanched before snap freezing and packing. The cut green beans are instantly quick frozen (IQF) and packaged in a pre-printed sealed plastic bag, 2 lbs. of product per bag, 12 - 2 lbs. bags per master carton. Lots: L6X 0424130911RY, Best before 04/24/2015; L1X 0404130814RY, Best before 04/04/2015; L1X 0404130815RY, Best before 04/04/2015; L1Y 0311132059RY, Best before 03/11/2015 Class II The product was found to be contaminated with Listeria monocytogenes based on private laboratory testing. Restaurant Depot
Food Meijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner). SKU: 00569, Lot Codes: 3221G00569, 3221H00569, 3221I00569 Shelf life (Exp. Date): Best if Used Before: 2/5/2014 Class II Product was found to contain foreign material, flexible plastic. Maplehurst Bakeries, Inc.
Food Fresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802*** Lots: 50 143233; 50 243233; 50343233; and 50 443233 Class III Fresh basil may be adulterated with pesticides. Shenandoah Growers, Inc.
Food Basil, fresh, Giant brand, packaged in 2.5 oz. package and labeled in part ***Distributed by FoodHold USA Landover, MD 20785*** Lots: 50 143233; 50 243233; 50343233; and 50 443233 Class III Fresh basil may be adulterated with pesticides. Shenandoah Growers, Inc.
Food Irene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bicarbonate, mono calcium phosphate, soy lecithin, natural flavors. May contain traces of tree nuts. Manufactured by Irene's Bakery and Gourmet Kitchen, Bensalem, PA. actual date code information are not available. Two-week expiration dates are assigned by the retail store upon receipt of shipment from the manufacturer. Class I Undeclared whey powder (milk allergen) sub-ingredient of chocolate confectionery coating used in manufacturing of Black & White Cookies. Irene's Bakery & Gourmet Kitchen, Inc.
Food Dannon ACTIVIA® LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup UPC 36632 02764 With the following expiration codes: Expiration code of PLT 49-64 SEP 24 2013 WJ, Expiration code of PLT 49-64 SEP 29 2013 WJ, Expiration code of PLT 49-64 OCT 08 2013 WJ Class II Dannon Company is recalling certain lots of ACTIVIA® LIGHT Nonfat Yogurt Strawberry/Banana & Peach Flavors due to the potential for mold. The Dannon Company, Inc
Drugs Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX. Lot #: P50EO07121390A, Exp 1/12/14 Class II Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. Walgreens Co
Food Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with "Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12 units 758843915950, 1.0 oz., case of 50 units 758843915752, With "Enjoy By" dates prior to 091614 Class II Semifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient. Semifreddi's Inc.
Food Chocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with "Enjoy By" dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product Size and UPC codes: 0.65 oz., case of 100 units 758843915943 0.89 oz., tub of 22 units 758843916001 1.3 oz., box of 4 units 758843915745 1.3 oz., box of 12 units 758843915967 1.3 oz., case of 50 units 758843915905 with Enjoy By date prior to 091614 Class II Semifreddi's Almond Biscotti and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient. Semifreddi's Inc.
Devices Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. REF: 1150000 Lot: 0207029284 Class II One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. Medtronic Xomed, Inc.
Food Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs) Fancy Mixed Nuts: LOT2013.09.09 Mixed Nuts: LOT2013.09.12 Super King Fancy Mixed Nuts: LOT2013.08.23 Class II American Nuts is recalling Mixed Nuts because they may contain undeclared wheat allergen. American Nut Company
Food Sensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901 Best Before 2013 SE 26; Batch number WO2013252 Class II Canadian product only - Sensations Spinach salad kit was packed in Sensations Asian Supreme Salad kit. The spinach kit contains feta cheese and milk is not listed on the ingredient statement as the source of the cheese as required by FALCPA. Taylor Farms Retail, Inc.
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