Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
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.
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
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
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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.
The product was distributed to manufacturers and distributors nationwide and to Canada and Taiwan.
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***
Raw material enzymes intended for further manufacturing of animal feed may be contaminated with chloramphenicol.
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
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
Worldwide Distribution-USA (nationwide) and the countries of  Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
Trabecular Metal'' Reverse Shoulder System
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.
Worldwide Distribution: USA (nationwide) and the country of Germany.
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
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of  Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.
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
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
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.
19,368 units total (10,328 for lot 212 and 9,040 for lot 292)
Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, Hawaii and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spian, Finland, France, IK, Greece, Israel, Italy, Malta, Netherland,s, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
''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
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.
''Renasys EZ PLUS''  a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Worldwide Distribution -  USA Nationwide including the states of  AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA.  HI,  IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt,  Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.
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.
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
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.
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.
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)
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of  Bermuda and Canada.
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.
38,890 units (7,860 units imported into the US)
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
USA Distribution in the state of Illinois.
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.
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.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, with insufficient plasma volume to support the platelet yield, was distributed.
Winter Haven Hospital Community Blood Center, Inc.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, collected from a donor who received an ear piercing within 12 months of donation, was distributed.
Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
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)
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.
Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Siemens Artis zee Ceiling Systems.   Angiographic x-ray system.
Artis zee Ceiling systems serial numbers from 146352 to 147617
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.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Talecris Plasma Resources Inc Dba International Bioresources
Blood product, collected from a donor who was incarcerated for more than 72 hours within 12 months of donating, was distributed.
Blood products, which may not have met the criteria for leukoreduced products because the WBC count was performed incorrectly, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
USA Nationwide Distribution in the state of LA, NJ, and NY.
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.
Sterility of medical devices intended for use in surgical procedures may be compromised.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
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.
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 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.
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.
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.
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.
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.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from a donor who had previously been deferred, was distributed.
Blood products, collected from a donor with Porphyria Cutanea Tarda, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood product, which did not meet the manufacturer's instructions for preparing a leukoreduced product, was distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
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.
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).
Blood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Quality Control  and Distribution/Distribution of product that did not meet specifications.
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.
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
Blood products, with no assurance that platelet counts met the specified minimum requirement, were distributed.
Blood product, which failed to meet the criteria for total weight during a validation study of the collection scales, was distributed.
Newmans Own Organics Newmans Special Blend 80 Count K-Cup Packs; UPC 09955515593; Product Code:  15593 281792
Some individual Coffee K-Cup packs (caffeinated)  received Decaffeinated lids/labels during packaging.
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada,  Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic,  Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
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.
The tracheal tube can kink during patient use.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Blood Centers of the Pacific - Irwin Center
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
American National Red Cross, Penn Jersey Region
Blood products, with unacceptably high platelet yields, were distributed.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and the countries of  Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.
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.
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.
Blood products, in which donor testing was not performed or incomplete, were distributed.
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.   Single Use acute or chronic hemanalysis treatment.
Dialysate Port Leak During Priming of the Dialyzers
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.   Single Use acute or chronic hemanalysis treatment.
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E.   Single Use acute or chronic hemanalysis treatment.
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N.   Single Use acute or chronic hemanalysis treatment.
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.   Single Use acute or chronic hemanalysis treatment.
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N.   Single Use acute or chronic hemanalysis treatment.
Optiflux F200A High Flux Dialyzers; Product Number: 0500320A.   Single Use acute or chronic hemanalysis treatment.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E.   Single Use acute or chronic hemanalysis treatment.
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E.   Single Use acute or chronic hemanalysis treatment.
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of  ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ IRELAND ISRAEL ITALY JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LITHUANIA MACAU MALAYSIA MALTA MAURITIUS MOROCCO MYANMAR (Burma) NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PALESTINE PERU PHILIPPINES POLAND PORTUGAL,QATAR ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SERBIA SEYCHELLES SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VIET NAM.
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.
HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Instrumentarium Dental, PaloDEx Group Oy
Worldwide Distribution: US (Nationwide) including states of: AK, AZ, CA, CO, GA, IL, KY, MD, MT, NC, NV, OR, PA, TN, TX, UT, VA, WA,and  WI; and Internationally to: Belgium Brazil, Chile, China, Czech Republic, France, Germany, Italy, Spain, Sweden, Switzerland, and United Kingdom.
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.
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.
Tijuana's Produce is recalling cactus leaves (nopales) due to unapproved levels of pesticide contamination.
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
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
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
Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2
All lots up to and including Best Before 2015JA06, 20150106, 150106
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
All lots up to and including Best Befor 2015JA06, 20150106, 150106
Bozzutos Inc. is recalling Kinnikinnick Food's bakery products due to undeclared milk.
Cactus Leaves/Pads (Nopales)   MexpoGroup Brand  MexpoGroup Fresh Produce  Colonia Buenos Aires Norte,  Tijuana, Baja California, Mexico.
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.
Distribution was nationwide.  There was no foreign/military/government distribution.
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;
The products are being recalled due to the receipt of a relatively high number of consumer complaints.
Worldwide Distribution - USA (nationwide) and the countries of: Canada, France, Germany, and Sweden
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.
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Worldwide Distribution - USA (nationwide) including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and to the country of: Canada.
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.
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.
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.
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.
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.
Worldwide Distribution - USA Nationeide and in the country of Chile.
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.
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
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.
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Worldwide Distribution - USA (nationwide) including the states of  AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of   ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.
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.
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.
Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
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.
Inner spherical radius of the shell is undersized.
US Distribution including the states of NY, TX, ID, AR, CA and AL
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.
Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359
Unified Grocers is recalling special value ginger snap cookies because it was mislabeled and it contains undeclared egg.
US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
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.
The product may contain high levels of microbial contamination
Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.
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.
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.
Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma) NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN
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
HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Canada, AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and YEMEN.
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.
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.
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
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC, KUWAIT, LATIVA, LEBANON, LIBYAN ARAB, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA,  RUSSIAN FEDERAL, SAUDIA ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE, THAILAND, TRINIDAND AND TABAGO, TUNISIA, TURKEY, TURKMENISTANIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIETNAM.
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
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
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
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.
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
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.
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.
Product was distributed to the following states: IN, KY and TN
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
271/1 lb plastic bags + 41 cs/25 lb plastic bags
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 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
''***Brazo gitano (rolled cake)***pineapple paste filling***''
Approx. 2300/14-oz rolls for all varieties
''***Brazo gitano (rolled cake)***pumpkin paste filling***''
''***Brazo gitano (rolled cake)***pistachio filling***''
''***Brazo gitano (rolled cake)***guava paste filling***''
''***Brazo gitano (rolled cake)***coconut filling***''
''***Brazo gitano (rolled cake)***mango filling***''
''***Brazo gitano (rolled cake)***cheese filling***''
''***Brazo gitano (rolled cake)***chocolate cake filling***''
''***Brazo gitano (rolled cake)***bavarian cream cake filling***''
''***Brazo gitano (rolled cake)***lemon filling***''
''***Brazo gitano (rolled cake)***guava-cheese filling***''
''***Brazo gitano (rolled cake)***mango-cheese filling***''
''***Brazo gitano (rolled cake)***strawberry filling***''
''***Brazo gitano (rolled cake)***chocolate filling***''
''***Brazo gitano (rolled cake)***coconut-pineapple filling***''
''***Brazo gitano (rolled cake)***papaya-cheese filling***''
''***Brazo gitano (rolled cake)***pineapple-cheese filling***''
Distributed nationwide to physicians as samples.  No military/ govt/ VA or foreign consignees.
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.
Subpotent Drug: Drug potency was compromised during shipment.
Nationwide, no military/govt/VA or foreign consignees.
Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0
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.
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
Reports of mild flushing reaction after consumption of product led to concern of possible production issue.  Flushing condition resolved itself within two hours.
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
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
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
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
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
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.
US: Nationwide (CA, CT, FL, GA, IL, KS, MI, NJ, NM, NV, NY, OH, PA, TX, VT ,WI)
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.
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.
Worldwide Distribution - USA (nationwide) including states of: AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and to the countries of: Australia, Norway, and Spain.
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.
Wireless Link may be unable to transmit data when configured for a specific data flow.
Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA,  BANGLADESH,  BELGIUM,  BRAZIL,  CANADA,  CHINA,  COLOMBIA,  ETHIOPIA,  FINLAND,  FRANCE,  GEORGIA,  GERMANY,  HUNGARY,  INDIA,  INDONESIA,  IRELAND,  ITALY,  JAPAN,  KAZAKHSTAN,  KOREA, REPUBLIC OF,  MALAYSIA,  MEXICO,  MONACO,  NEPAL,  NETHERLANDS,  PORTUGAL,  SINGAPORE,  SOUTH AFRICA,  SPAIN,  SRI LANKA,  SWITZERLAND,  TAIWAN, PROVINCE OF CHINA,  THAILAND,  UNITED KINGDOM,  UZBEKISTAN,  VENEZUELA,  and VIET NAM,
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.
Philips HeartStart XL may experience a power board failure causing failure to defibrillate
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
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.
Worldwide Distribution-USA (nationwide) and the countries of  AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN.
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
ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
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.
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.
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.
Products may contain undeclared coconut.
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
The dietary supplement lot contains Chloramphenicol at a level of 9.7 ppb.
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
Presence of Particulate Matter: Red Silicone Rubber Particulates are Present in Drug.
Newman's Own Salsa Con Queso, Medium All Natural  Net Wt.16 oz.,  packaged in a glass jar   UPC 0 20662 00353 9
Product was distributed to retail stores in NE, CO, WY. No foreign, military/govt/VA consignees.
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.
L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles due to an undeclared allergen.  The product label does not declare ''wheat'' flour.