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U.S. Department of Health and Human Services

Enforcement Report - Week of March 5, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 104153331 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. Blood Systems, Inc.
Devices DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible. Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046 Class II It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems Elekta, Inc.
Devices ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ26855D; Lots: 13EB2046, 13EB8965 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ39185; Lots: 13EB2046, 13FB1553, 13GB2605 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ40926; Lot: 13FB4759 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ41101; Lot: 13FB5744 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. Pack Number: DYNJ41103; Lots: 13GB5484, 13GB9975 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.. Pack Number: SAMP0144; Lots: 13CD2145, 13CD2146 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. Pack Number: SAMP0213; Lot: 13CD1774 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. Pack Number: SAMP0147; Lot: 13CD2146 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. Pack Number: DYNJ40851; Lot: 13FB8753 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Devices CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures. Pack Number: DYNJ40904; Lot: 13GB9975 Class I Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Medline Industries, Inc.
Veterinary Cellulase Enzyme Blends, bulk, custom blended formulations identified as Feed Sources blend and P-one blend, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: fsb-vw08 pob-tw31 Class II Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol. Bio-Cat Inc
Veterinary Pectinase Enzyme Blends, bulk, custom blended formulations identified as Synerzyme-AE, Brizyme, EB-7 Multi-Enzyme Blend, Enzyme 7x, Pectinase 3,000 ENDO PG/GM, and Enzyme Blend Y2X, in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: BRI-XW16 EB7-XW08 E7X-TW03 PE003-UW21 EBY2X-UW22 Class II Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol. Bio-Cat Inc
Veterinary Xylanase Enzyme Blends, bulk, custom blended formulations identified as Synerzyme-ae, Brizyme, Cellulase Special Blend OMRI, Xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws, Alkacel 20x, BC-XR, Enzyme blend #2237, CHX blend, and EB-7 multi-enzyme blend, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, and labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com*** Lots: synae-vw18 bri-xw16 csbomri-xw20 xab-vw21 bcr-yw14 fbws-uw04 alc20-ww05 bcxr-tw04 eb2237-vw14 chxb-uw27 eb7-xw08 Class II Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol. Bio-Cat Inc
Devices Trabecular Metal" Reverse Shoulder System 61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880,  ...
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Class II As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate. Zimmer, Inc.
Devices Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., 3451 Plano Pkwy, Lewisville, TX 75056 USA. Tel: 1-888-298-5700/1-214-937-2000, RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine. 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date Class II There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. Orthofix, Inc
Devices VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Product Code 8379034; Affected Generations (GENs)/Lots: GENs 7 - 13; Expiry Dates: 2013-11-01 thru 2015-01-01 Class II Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. Ortho-Clinical Diagnostics
Devices VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG. Product Code 1662659; Lots: 1) 212 and 2) 292; Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28. Class II Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. Ortho-Clinical Diagnostics
Devices "Renasys EZ" a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299 Class II Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters, which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems, communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling. Smith & Nephew Inc.
Devices "Renasys EZ PLUS" a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299 Class II Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters, which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems, communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling. Smith & Nephew Inc.
Devices GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. QABR50042, QABR50036, QABR50082, QABR50110, QABR50111, QABR50031, QABR50008, QABS50107, QABS50108, QABS50139, QABR50009, QABR50043, QABS50017, QABS50072, QABS50129, QABS50076, QABR50005, QABR50060, QABR50035, QABS50084, QABS50100, QABR50038, QABR50023, QABR50095, QABR50097, QABS50151, QABS50153, QABS50154, QABR50137, QABR50144, QABR50002, QABR50001, QABR50015, QABS50119, QABS50122, QABR50112, QABR50129, QABS50098, QABS50099, QABS50101, QABR50124, QABR50141, QABR50028, QABS50148, QABR50109, QABR50030, QABR50217, QABR50159, QABR50160, QABR50161,  ...
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Class I Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. GE Healthcare, LLC
Devices GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274 Class I Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. GE Healthcare, LLC
Devices GE Healthcare - Giraffe® and Panda® iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate. HDJQ52826, HDJR52093, HDJR50704, HDJR54140, HDJR54141, HDJR54142, HDJR54143, HDJQ52878, HDJS50670, HDJS50671,HDJS50672, HDJS50678, HDJS50679, HDJS50681, HDJS50682, HDJS50684, HDJS50686, 208600, 208601, 208610, HDJS51010, HDJR56405, HDJS52316, HDJP51364, HDJP51369, HDJP51376, HDJP51379, HDJP51380, HDJP51381, HDJR56387, HDJR56388, HDJR56389, HDJR56390, HDJR56391, HDJR56666, HDJN50977, HDJN50978, HDJP51983, HDJQ53071, HDJM51282, HDJM51283, HDJM51284, HDJM51285, HDJM51286, HDJM51287, HDJM51288, HDJM51289, HDJM51290, HDJM51291, HDJM51292, HDJM51293,  ...
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Class I Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. GE Healthcare, LLC
Drugs Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton) lot 58468552 Exp. 05/15 Class II Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. Actavis Elizabeth LLC
Devices pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes. Model #: 942-063 Lot #'s: R338 to R493 Class II RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. Radiometer America Inc
Devices 00434811113, REF I4348-111-13 Zimmer® Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem LengthTrabecular Metal" Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth. lot 62267250 Class II This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification. Zimmer, Inc.
Biologics Red Blood Cells Leukocytes Reduced W035213118675A Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213118675A Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets Pheresis Leukocytes Reduced W071213048078 Class II Blood product, with insufficient plasma volume to support the platelet yield, was distributed. Medic Inc
Biologics Blood and Blood Products for Reprocessing W222111101736 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Winter Haven Hospital Community Blood Center, Inc.
Biologics Platelets Leukocytes Reduced W051713811110 Class II Blood product, collected from a donor who received an ear piercing within 12 months of donation, was distributed. Rhode Island Blood Center
Devices PFC® SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility. Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS) Class II PFC® SIGMA Cruciate Retaining (CR) Cemented Femoral devices were found to have anomalous microstructure. Due to the manufacturing method employed, there may be the potential for increased levels of porosity, as well as blocky grain boundary carbides in the microstructure when compared to parts manufactured under the current accepted and validated protocols. Porosity and the presence of blocky carbides, within the cobaltchrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads. DePuy Orthopaedics, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 12KR889661; 12KR889662; Class II Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed. American National Red Cross (the)
Devices Siemens Artis zee Ceiling Systems. Angiographic x-ray system. Artis zee Ceiling systems serial numbers from 146352 to 147617 Class II During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage. Siemens Medical Solutions USA, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2036521; 2036521; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma 2297584; 2385378; W036810163635; 2301005; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells 2385378; W036810163635; 2297584; 2301005; 2777223; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced 2297584; W036810816301; 2301005; 2777223; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Source Plasma 3680276999; Class II Blood product, collected from a donor who was incarcerated for more than 72 hours within 12 months of donating, was distributed. Talecris Plasma Resources Inc Dba International Bioresources
Biologics Platelets Pheresis Leukocytes Reduced W037913564193; W037913555356; W037913555356; W037912890103; W037912890103; Class II Blood products, which may not have met the criteria for leukoreduced products because the WBC count was performed incorrectly, were distributed. LifeServe Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W037913564890; W037911893490; Class II Blood products, which may not have met the criteria for leukoreduced products because the WBC count was performed incorrectly, were distributed. LifeServe Blood Center
Devices VirtuoSaph® Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K Class II Sterility of medical devices intended for use in surgical procedures may be compromised. Terumo Cardiovascular Systems Corporation
Biologics Source Plasma LC0785600; LC0785942; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Las Cruces Biologicals LLC
Food The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922714 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Food The Cultured Kitchen Smoked Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 736211079134 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Food The Cultured Kitchen Pepper Jack Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922615 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Food The Cultured Kitchen Habanero Cilantro Lime Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922813 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Food The Cultured Kitchen Pesto or Basil Pesto Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504851120 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Food The Cultured Kitchen White Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504924015 Produced by: The Cultured Kitchen LLC Sacramento, CA. All expiry dates up to and including 4/19/2014. Class I Six varieties of Cashew Cheese with an expiry date up to and including 4/19/2014 are being recalled due to the potential for Salmonella contamination. The Cultured Kitchen
Biologics Red Blood Cells Leukocytes Reduced Irradiated W065613007822; Class II Blood product, collected from a donor who had previously been deferred, was distributed. Bergen Comm Reg Blood Center
Biologics Fresh Frozen Plasma W045013091254 Class III Blood products, collected from a donor with Porphyria Cutanea Tarda, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced W045013093415, W045013091254 Class III Blood products, collected from a donor with Porphyria Cutanea Tarda, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced W270113516227 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Central Pennsylvania Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W067113060580 Class III Blood product, which did not meet the manufacturer's instructions for preparing a leukoreduced product, was distributed. The Blood Center
Biologics Fresh Frozen Plasma W036810172390 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W036810172390 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W120613068130; Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W036512122900, W036512066221 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W066513703061; W066513703071; W066513703101; W066513703115; W066513703121 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Blood Bank of Alaska, Inc.
Devices Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System. lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014. Class II Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL). Siemens Healthcare Diagnostics, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W068513012979; W068513012979; W068513012979; Class II Blood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed. Inland Northwest Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050913066210; Class II Quality Control and Distribution/Distribution of product that did not meet specifications. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W050913066210; Class II Quality Control and Distribution/Distribution of product that did not meet specifications. HCSC-Blood Center
Devices The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use. Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322 Class II OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. Ossur Americas, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W227013054019; W227013054019; W227013054019; Class II Blood products, with no assurance that platelet counts met the specified minimum requirement, were distributed. Community Blood Center of Carolinas
Biologics Red Blood Cells Leukocytes Reduced W20071302139300; Class III Blood product, which failed to meet the criteria for total weight during a validation study of the collection scales, was distributed. American National Red Cross, The
Food Newmans Own® Organics Newmans Special Blend 80 Count K-Cup® Packs; UPC 09955515593; Product Code: 15593 281792 Lot Number: LA 15593 PL086 3300 Class II Some individual Coffee K-Cup® packs (caffeinated) received Decaffeinated lids/labels during packaging. Green Mountain Coffee Roasters
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055 and 01F1300297. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13014, Lot numbers: 01A1000326, 01B1000081, 01A1000502, 01B1000256, 01A1000549, 01G1000048, 01J1000341, 01M1000185, 01C1100227, 01C1100150, 01B1100464, 01B1100237, 01E1100346, 01F1100505, 01D1100077, 01F1100031, 01H1100158, 01D1100330, 01C1100371, 01C1100400, 01C1100626, 01C1200266, 01D1200419, 01C1200466, 01E1200204, 01D1100299, 01F1200172, 01H1200411, 01K1200231, 01G1200206, 01J1200072, 01G1200285, 01G1200452, 01E1200546, 01L1200131, 01K1200336 and 01E1300296. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095  ...
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Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284, 01B1100011, 01B1100070, 01C1100114, 01C1100529, 01E1100227, 01C1100606, 01B1100505, 01B1100248, 01H1100103, 01A1200116, 01B1200547, 01B1200422, 01E1100492, 01C1200085, 01C1200385, 01D1100348, 01D1200270, 01D1200087, 01G1100117, 01E1200562, 01G1200079, 01C1300339, 01C1300437, 01D1300076, 01E1300297, 01D1300194 and 01E1300061. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-13018, Lot numbers: 01A1000435, 01D1000122, 01G1000099, 01J1000398, 01A1100276, 01A1100516, 01B1100012, 01F1100336, 01C1100113, 01A1200212, 01G1200208, 01G1100440 and 01D1100342 Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14012, Lot numbers: 01A1200213 and 01A1200341. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14013, Lot numbers: 01A1200341 and 01B1200423. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14014, Lot numbers: 01B1200106, 01D1200157 and 01B1200424. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14015, Lot numbers: 01B1200107, 01J1200211, 01C1200387, 01H1200157, 01E1300478 and 01K1300343. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14016, Lot numbers: 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036 and 01J1300339. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14017, Lot numbers: 01B1200215. Class I The tracheal tube can kink during patient use. Teleflex Medical
Devices ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. Product Code: 5-14018, Lot numbers: 01B1200213 and 01B1200336. Class I The tracheal tube can kink during patient use. Teleflex Medical
Biologics Red Blood Cells Leukocytes Reduced W117013546525; Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Plasma Frozen W117013546525; Class III Blood products, collected from a donor whose arm inspection was not documented, were distributed. Blood Centers of the Pacific - Irwin Center
Biologics Platelets Pheresis Leukocytes Reduced W20221380115300; W20221380115300; Class II Blood products, with unacceptably high platelet yields, were distributed. American National Red Cross, Penn Jersey Region
Devices Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. BrightView SPECT, Product code: 882480; Serial #'s: 400054, 4000002, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000029, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061,  ...
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Class II Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As the gantry system was moving to a relative 90 scan position of the detectors, a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. While a user was manually positioning a patient for their exam and translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. Philips Medical Systems (Cleveland) Inc
Biologics Platelets Pheresis Leukocytes Reduced W067113708039- part 1; W067113708039- part 2 Class II Blood products, in which donor testing was not performed or incomplete, were distributed. Blood Center Hammond Laboratory (the)
Devices Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13LU01001 13KU05018 13LU05001 13KU06026 13LU06001 13LU06002 13LU05002 13LU06003 13LU01007 13LU01008 13LU01009 13LU05003 13LU05004 13LU05005 13LU05006 13LU05007 13LU05008 13LU06004 13LU06005 13LU06006 13LU06008 13LU06009 13LU06010 13LU06011 13LU06012 13LU06013 13LU06014 13LU06015 13LU06016 13LU01010 13LU01011 13LU06017 13LU06018 13LU01012 13LU01013 13LU05014 13LU06019 13LU06020 13LU06021 13LU01015 13LU05015 13LU06022 13NU05002 13NU06002 13NU01004 13NU05003 13NU06003 13NU06004 13NU06007 13NU01005 13NU01006 13NU01007 13NU01008 13NU06008 13NU06009 13NU06010 13NU06011 13NU06012 13NU06013 13NU06014 13NU01009 13NU01010 13NU06015 13NU06016 13NU06017 13NU06018 13NU06020 13NU06021 13NU06022 13NU06023 13NU06024 13NU06025 13NU06026 13NU06027 13NU01015 13NU01016 13NU01017 13NU01018 13PU01001 13PU01002 13PU01003 13NU06029 13PU06001 13PU06002 13PU06018 13PU01013 13PU01014 13PU01015 13PU01017 13PU06019 13PU06020 13PU06021 13PU06022 13PU06023 13PU06024 13PU06025 13PU06026 13PU06027 13PU06028 13SU06004 13SU06005 13LU06023 13LU06024 13LU06025 13LU06027 13LU06028 13NU06001 13LU05016 13LU01016 13LU01017 13NU01001 13LU05017 13NU01002 13PU06003 13PU01004 13PU01007 13PU06006 13PU06007 13PU01008 13PU01010 13PU01011 13PU01012 13PU06015 13PU06016 13PU06017 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13NU01014 13SU01001 13SU01002 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13LU02004 13LU02005 13LU02008 13LU03006 13LU03007 13LU03008 13LU04005 13LU04006 13LU04007 13LU04008 13LU04009 13LU04010 13LU03009 13LU03010 13LU03011 13LU03012 13LU04011 13LU04012 13LU03014 13LU02018 13LU03015 13LU03016 13LU03017 13LU03018 13NU03001 13NU02001 13NU03002 13NU03004 13NU03005 13NU02005 13NU02006 13NU02007 13NU03006 13NU03007 13NU03008 13NU03009 13NU05006 13NU05007 13NU05009 13NU03011 13NU03012 13NU04011 13NU05016 13NU05017 13NU05018 13NU03018 13NU04017 13PU02003 13NU03019 13PU03001 13PU03002 13PU03003 13PU05002 13PU05003 13PU02004 13PU02005 13PU02006 13PU02007 13PU03004 13PU03006 13PU03007 13PU03008 13PU05004 13PU02010 13PU02011 13PU02012 13PU03010 13PU04011 13PU04012 13PU04013 13PU05009 13PU05010 13PU05011 13PU02013 13PU02014 13PU02015 13PU02016 13PU02017 13PU03013 13PU03014 13PU03015 13PU03016 13PU03017 13PU04014 13PU05016 13PU05017 13SU05001 13SU02003 13SU03004 13SU02004 13NU04012 13NU05010 13NU05011 13NU02012 13NU02013 13NU02014 13NU03016 13NU03017 13NU04015 13NU04016 13NU05014 13NU05015 13PU04015 13PU04016 13PU04017 13PU04018 13PU05012 13PU05013 13PU05014 13PU05015 13PU02018 13PU02019 13SU02001 13PU04019 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13NU03003 13NU03010 13PU04010 13SU03001 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment. Lot Number: 13NU04008 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment. Lot Number: 13NU04009 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment. Lot Numbers: 13LU02011 13LU02013 13NU02016 13NU02017 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment. Lot Number: 13PU03011 Class II Dialysate Port Leak During Priming of the Dialyzers Fresenius Medical Care Holdings, Inc.
Devices Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support. Serial Numbers: Serial Number Range USO1100106-USO1100372 USN1100376-USN1100960 USD1100961-USD1101095 US11201095-US11201186 US21201187-US21201239 US31201240-US31201537 US41201538-US41201585 US51201586-US51201721 US61201722-US61201924 US71201925-US71202048 US81202049-US81202168 US91202169-US91202514 US01202515-US01202990 USN1202991-USN1203537 USD1203538-USD1203968 US11303969-US11303972 US21303980-US21304488 US31304489-US31305042 US41305043-US41305295 US51305296-US51305450 US61305451-US61306138 US71306139-US71306542 US81306543-US81306998 US91306999-US91307261 US01307306-US01307458 Class II HeartStart XL+ battery charge time to 100% capacity at 35°C (95°F) is slightly longer than the specified 3 hour duration as stated in the labeling Philips Medical Systems, Inc.
Biologics Red Blood Cells W036810049239 Class II Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036810800088 Class II Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036810049239 Class II Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures. Device Model Number / Sales Code: 50600-IMG; Serial Numbers (US and Foreign): F21221 - F21641, and F21643; Serial Numbers (US Devices): F21221 - F21230, F21265 - F21270, F21273 - F21290, F21296 - F21350, F23154 - F21365, F21367 - F21391, F21395 - F21447, F21451 - F21464, F21469 - F21478, F21481 -  ...
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Class II Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS X-ray machines that had not been properly welded at our supplier. As a result of the incomplete welding operation, the wall mount unit on the FOCUS X-ray unit may not properly support the unit as expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, there is also a possibility that the wall mount unit will fail to support the weight of the unit, resulting in the FOCUS X-ray unit falling unexpectedly from its mounted position. Instrumentarium Dental, PaloDEx Group Oy
Food Cactus Leaves (Nopales), 44 lbs. n/a Class III Tijuana's Produce is recalling cactus leaves (nopales) due to unapproved levels of pesticide contamination. Tijuana'S Produce Co.
Food Kinnikinnick Original Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300198 1 All lots up to and including Best Before 2014AU10, 20140810, 140810 Class I Undeclared milk. UNFI
Food Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300199 8 All lots up to and including Best Before 2014AU11, 20140811, 140811 Class I Undeclared milk. UNFI
Food Kinnikinnick Kinni-Kwik Bread & Bun Mix-Weight 350g/16oz Cardboard Box UPC 62013310550 4 All lots up to and including Best Before 2014DE19, 20141219, 141219 Class I Undeclared milk. UNFI
Food Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2 All lots up to and including Best Before 2015JA06, 20150106, 150106 Class I Undeclared milk. UNFI
Food Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3 All lots up to and including Best Before 2014AU09, 20140809, 140809 Class I Undeclared milk. UNFI
Food Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2 All lots up to and including Best Befor 2015JA06, 20150106, 150106 Class I Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk. Bozzutos' Inc.
Food Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3 All lots up to and including Best Before 2014AU09, 20140809, 140809 Class I Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk. Bozzutos' Inc.
Food Cactus Leaves/Pads (Nopales) MexpoGroup Brand MexpoGroup Fresh Produce Colonia Buenos Aires Norte, Tijuana, Baja California, Mexico. no code numbers Class II CA Dept of Pesticides tested Cactus pads and found pesticides Monocrotophos at 0.581 ppm, Carbendazim as Thiophanate Methyl at 0.510 ppm and Captan (THPI) at 0.313 ppm. There is no tolerance for these pesticides in the US. RCI Produce
Food Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefiber Fiber Supplement, On-The-Go Stick Packs, Sugar Free, Clear & Taste-Free, packaged in 8.16-oz. boxes containing 68/0.12-oz. stick packs, UPC 300670176686. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; (2) Benefiber Fiber Supplement, Taste Free, Sugar Free, packaged in 0.36-oz. foil packages containing 3/0.12-oz. stick packs, UPC 300670186036. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; (3) Benefiber Fiber Supplement, Taste Free, Sugar Free, packaged in 0.36-oz. foil packages containing 3/0.12-oz. stick packs, 8/0.36-oz. foil packages clipped together on a strip, UPC 300679110766. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ; 68-ct. boxes - 25574002, 25515001, 25515002, and 25574001, all with exp. dates of 02/2014; 3-ct. packages - 26096201, exp. 07/2014; 26096203, exp. 07/2014; 26096202, exp. 07/2014; and 26248201; exp. 05/2014; 8-package clip pack - 26128701, exp. 07/2014, and 26128702, exp. 07/2014. Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Devices NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J13D0 34009J13D0 34011J13D0 33868H13D0 33869H13D0 33870H13D0 33871H13D0 33872H13D0 33873H13D0 33874H13D0 33875H13D0 33876H13D0 33877H13D0 33878H13D0 33879H13D0 33880H13D0 33881H13D0 33882H13D0 33883H13D0 33884H13D0 33885H13D0 33886H13D0 33888H13D0 33889H13D0 33890H13D0 33891H13D0 33892H13D0 33893H13D0 33894H13D0 33895H13D0 33896H13D0 33897H13D0 33898H13D0 33900H13D0 33901H13D0 33902H13D0 33903H13D0 33904H13D0 33948I13D0 33951I13D0 33952I13D0 33953I13D0 33954I13D0 33955I13D0 33956I13D0 33957I13D0 33958I13D0 33959I13D0 33960I13D0 33961I13D0 33962I13D0 33963I13D0 33964I13D0 33965I13D0 33966I13D0 33967I13D0 33968I13D0 33969I13D0 33978J13D0 33979J13D0 33980J13D0 33981J13D0 33982J13D0 33983J13D0 33984J13D0 33990J13D0 33991J13D0 33995J13D0 33997J13D0 33998J13D0 34000J13D0 34001J13D0 34003J13D0 34017K13D0 34021K13D0 34023K13D0 34026K13D0 34027K13D0 34028K13D0 34029K13D0 34031K13D0 34032K13D0 34033K13D0 34035K13D0 34039K13D0 Class II NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, Hologic, Inc
Devices PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. Model 5570. Serial numbers: 557A1100178 thru 557A100206. Class II This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position. Winco Mfg., LLC
Devices CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. Model(s) 5251, 5261, 525S, 526S: Serial Numbers: 525108626 thru 525108774, 526100851 thru 526100919, 525S100070 thru 525S100081, 526S100037. Class II This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position. Winco Mfg., LLC
Devices DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. Model(s) 5271, 5281. Serial numbers: 527A101756 thru 527A101816, 528A100187 thru 528A100199. Class II This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position. Winco Mfg., LLC
Devices XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. Model(s) 5291, 529S. Serial numbers: 529A003767, 529A003779, 529A003787, 529A003790, 529A003792 thru 529A003865, 529S100044 thru 529100050. Class II This recall has been initiated due to a supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position. Winco Mfg., LLC
Devices Product Name: HER2 CISH pharmDx" Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 °C. Expiration Date: 2014 June 30. Class II Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Dako North America Inc.
Devices Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges. D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242 Class II Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter. Stryker Spine
Devices GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications. Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2  ...
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Class II GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient. If the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file. GE Healthcare, LLC
Devices Reflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Batch No. 13EM03053 Class II Inner spherical radius of the shell is undersized. Smith & Nephew Inc
Devices NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. Lot Number: F113662 Class II Mislabeled product. NxStage Medical, Inc.
Food Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359 Best By Date: SEP 23 14 Class I Unified Grocers is recalling special value ginger snap cookies because it was mislabeled and it contains undeclared egg. Unified Grocers Inc.
Devices Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp. Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015 Class II The product may contain high levels of microbial contamination Remel Inc
Devices Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters. US23200113, US23200120, US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169,  ...
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Class II Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use. Invivo Corporation
Devices Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028 Class II HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers Philips Medical Systems, Inc.
Devices HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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. Model M3535A: US00100100 to US00541372 Model M3536A: US00100902 to US00541375 Model M3536J: US00209838 to US00332675 Model M3536MC: US00500001 to US00500020 Class II A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform. Philips Medical Systems, Inc.
Drugs Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02 Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016 Class II Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER Caraco Pharmaceutical Laboratories, Ltd.
Devices HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J 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: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P Class II Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source Philips Medical Systems, Inc.
Devices cobas® PCR Urine Kit 100 PKT IVD cobas® PCR Female Swab Kit 100 PKT IVD cobas® PCR media 100T IVD cobas® PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas® PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas® PCR Female Swab Kit, cobas® PCR Urine kit, and cobas® PCR media 100 T kit. -The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas® CT/NG Test. - The cobas® PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas® CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas® PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas® CT/NG Test. K110923 cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884) IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches Class II Numerous complaints have been filed that leaking cobas ® PCR media 4.3 mL IVD have been received from different lots of the cobas ® PCR Urine kits, cobas ® PCR Female Swab kits, and cobas ® PCR media kits. Roche Molecular Systems, Inc.
Devices CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156. Class III Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. CSI is taking this action to remove the subject units from distribution in order to correct the error in the device build. These saline lines are in use with peripheral Orbital Atherectomy Device (OAD); therefore, there is no patient risk associated with this recall. Cardiovascular Systems, Inc.
Food Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405 with a white stick on label which reads, "25# BAR STAR MIX All product and lot codes Class II During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs. Creation Gardens
Food Creation Special Snack Mix 25 lb plastic bags in a cardboard box. Box labeled "DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405" with a white stick on label which reads, "25# CREATION SPECIAL MIX All product and lot codes. Class II During an inspection by the Kentucky Department for Public Health, the firm was informed that their product lacks an ingredient statement. Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs. Creation Gardens
Food "***Brazo gitano (rolled cake)***pineapple paste filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***pumpkin paste filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***pistachio filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***guava paste filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***coconut filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***mango filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***cheese filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***chocolate cake filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***bavarian cream cake filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***lemon filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***guava-cheese filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***mango-cheese filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***strawberry filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***chocolate filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***coconut-pineapple filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***papaya-cheese filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Food "***Brazo gitano (rolled cake)***pineapple-cheese filling***" no code Class II Undeclared allergens: wheat E. Franco & Co. Inc
Drugs Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77. Lot #: 514656; Expiry: 03/14 Class III Subpotent Drug: Drug potency was compromised during shipment. Actavis
Food Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0 Julian packed-on date 13-351 Class I Natural Grocers by Vitamin Cottage is recalling one lot of six ounce packages of Natural Grocers brand Dark Chocolate Almonds with the Julian packed-on date 13-351 because some bags in this lot may contain dark chocolate covered peanuts which are not declared on the label. Natural Grocers by Vitamin Cottage
Food Uncle Ben's (R), Infused(R) Rice Mexican Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Roasted Chicken Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059 All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Garlic & Butter Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059 All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Pilaf, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547 All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Saffron Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547 All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Spanish Flavor, net weight 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059 All codes Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Uncle Ben's (R), Infused(R) Rice Cheese Flavor, net weight 5 LB (2.27 kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-1547 All codes. NOTE: The firm placed this product on their recall list as a precaution as although the shelf life is one year, it could still be on the market. Class II Reports of mild flushing reaction after consumption of product led to concern of possible production issue. Flushing condition resolved itself within two hours. Mars Food US
Food Candy coated popcorn shaped into a heart weighing 1.5 ounces per piece and individually wrapped in clear plastic packaging. There are 24 popcorn balls per case. Product Lot Number: 14022. Case Lot Number: 14034. Expiration Date: April 7, 2014. Class II The Nutrition Facts and allergen label was not applied individual popcorn balls in a Valentine's Day promotion package. The popcorn balls contain milk and soy allergens. Popcorn Factory, The
Devices M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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. US00100253, US00547494, US00565643, US00567331, US00100950, US00558361, US00565651, US00567332, US00204282, US00560173, US00565652, US00567333, US00210992, US00560174,US00565653, US00567334, US00210993, US00560175, US00565655, US00567335, US00210994, US00560176, US00565656, US00567336, US00210995, US00560177, US00565657, US00567337, US00210996, US00560178, US00565658, US00567338, US00210997, US00561068, US00565660, US00567339, US00210998, US00561724, US00565661, US00567340, US00210999, US00563602, US00565662, US00567341, US00211000, US00563603, US00565663, US00567720, US00211001, US00563606, US00565664,  ...
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Class II Wireless Link may be unable to transmit data when configured for a specific data flow. Philips Medical Systems, Inc.
Devices Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED Serial numbers within the range: US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013. Class II Philips HeartStart XL may experience a power board failure causing failure to defibrillate Philips Medical Systems, Inc.
Drugs Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 2407255, 2407256 Exp. 05/14 Class II Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. Ranbaxy Inc.
Devices Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation. Serial numbers within the range: US00100100 through US00550668 Class II ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal Philips Medical Systems, Inc.
Devices Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch. Lot Number: 50755851 Class III Incorrect master label. Medtronic Vascular
Food Multifoods Bakery Products, Cranberry Orange Muffins, 5.4oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 25.3lbs case is unit for sale. UPC 10035074485443. Manufactured by: CSM Bakery NA, Inc, Tucker, GA. Item# 48544, Lot# 1400300688, Expiration Date: 07/02/2014. Class II Products may contain metal dust. CSM Bakery Products NA
Food Multifoods Bakery Products, Artificial Pistachio Flavored Muffin with Other Nuts, 4.5oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 27 lbs case is unit for sale. UPC 024800486383. Manufactured by CSM Bakery Products NA, Inc., Tucker, GA. Item # 48638, Lot# 1401000970, Exp date 7/2/2014 Class II Products may contain undeclared coconut. CSM Bakery Products NA
Food True Botanica brand Enzymes Plus, 45 CAPSULES, Product No. TB043-45, a Dietary Supplement --- Manufactured for True Botanica LLC, 1005 Richards Rd, Suite D, Hartland, WI 53029 Lot No. 130951 Class II The dietary supplement lot contains Chloramphenicol at a level of 9.7 ppb. Nature's Value Inc.
Drugs Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster City, CA 94404 Made in Ireland Lot #'s: 002390, 002400, Exp 02/17. Class III Presence of Particulate Matter: Red Silicone Rubber Particulates are Present in Drug. Gilead Sciences, Inc.
Food Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9 Production code Use By dates: 3/28/15, 4/28/15, 5/28/15, 6/28/15, 7/28/15, 8/28/15 Class II Undeclared wheat Newman'S Own Inc.
Food Marlyce's Homemade Style Noodles, Net Wt. 8 oz, Packaged in plastic bags, 10 per case, UPC 094219217069. Manufactured by L.M.Noodle Company, LLC, 416 Main Street, Wiggins, CO 80654. UPC 094219217069, Class II L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles due to an undeclared allergen. The product label does not declare "wheat" flour. L. M. Noodle Company, LLC
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