The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
126
High
224
Moderate
219
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

201–300 of 588

  • SevereNHTSA·13V588000·2013-11-20

    Nissan Recalls 2014 Infiniti Q50 for Steering Software Defect

    Nissan is recalling 2014 Infiniti Q50 vehicles because freezing temperatures may disable electric steering and delay the mechanical backup, increasing crash risk.

    Product
    INFINITI — INFINITI Q50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0157-2014·2013-11-20

    Empirical Labs Recalls Greens Supplements for Chloramphenicol Contamination

    Empirical Labs is recalling specific lots of Go Green Fuel for the Entire Body dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0174-2014·2013-11-20

    GoPicnic Meal Kits Recalled for Undeclared Milk Allergen

    GoPicnic is recalling Black Bean Dip & Plantain Chips meal kits because the included chocolates may contain undeclared milk allergens.

    Product
    GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com;
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0205-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 71 Plum A+ Infusion Pumps because pressure sensor calibration drift can cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0186-2014·2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 508,029 cases of Combiset Blood Lines for hemodialysis because connections may disconnect if not tightened correctly, leading to blood loss.

    Product
    Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0144-2014·2013-11-20

    Apex Energetics Recalls Four Enzyme Supplements Due to Chloramphenicol Contamination

    Apex Energetics is recalling four enzyme-based dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0158-2014·2013-11-20

    ProThera Recalls Serralase Enzyme Supplements Due to Chloramphenicol Contamination

    ProThera, Inc. is recalling Serralase Enzyme Supplements because the enzymes used may be contaminated with chloramphenicol.

    Product
    Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·13V582000·2013-11-20

    Jet Co Aluminum Grain Trailers Recalled for Weak Top Rail

    Jet Co is recalling 2011-2012 aluminum grain trailers because a weak top rail may buckle, increasing crash risk.

    Product
    JET CO — JET CO ALUMINUM GRAIN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0167-2014·2013-11-20

    Beach Body Ultimate Reset Kit 2.0 Recalled for Chloramphenicol Contamination

    CGNP Manufacturing is recalling Beach Body Ultimate Reset Kit 2.0 because the raw material used in the formulation contains chloramphenicol.

    Product
    Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:" BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0146-2014·2013-11-20

    Empirical Labs Recalls Vanilla Energy Shake Supplements Due to Chloramphenicol

    Empirical Labs is recalling Natural Balanced Nutrition Vanilla Energy Shake dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Natural Balanced Nutrition Vanilla Energy Shake Dietary Supplement; Manufactured for NatureRich, Maple Grove, MN.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0166-2014·2013-11-20

    Beachbody Optimize Enzymes Capsules Recalled for Chloramphenicol Contamination

    CGNP is recalling Beachbody Optimize Enzymes Capsules because the raw material used contains chloramphenicol. The recall covers 500 bottles distributed in California.

    Product
    Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:" BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1730-2013·2013-11-20

    Priester's Pecans Pistachios Recalled for Potential Salmonella Contamination

    Priester Pecan Company is recalling specific lots of roasted salted pistachios due to potential Salmonella contamination. The product was distributed nationwide and in Puerto Rico.

    Product
    PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0171-2014·2013-11-20

    Aunt Jemima Quick Grits Recalled for Aflatoxin Contamination

    Quaker Foods and Snacks North America is recalling Aunt Jemima Quick Grits because some bags contain aflatoxin levels above the legal limit.

    Product
    White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0160-2014·2013-11-20

    Klaire Labs Vital-Zymes Enzyme Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Vital-Zymes complete enzyme supplements because the enzymes may be contaminated with chloramphenicol.

    Product
    Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0172-2014·2013-11-20

    Aunt Jemima Grits and Corn Meal Recalled for Aflatoxin Levels

    Quaker Foods and Snacks North America is recalling specific lots of Aunt Jemima Quick Grits and Corn Meal Mix because they contain aflatoxin above legal limits.

    Product
    White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0156-2014·2013-11-20

    Empirical Labs Recalls P&L Enzymes Due to Chloramphenicol Contamination

    Empirical Labs is recalling specific lots of P&L Enzymes dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0162-2014·2013-11-20

    Klaire Labs Interfase Plus Enzyme Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Interfase Plus enzyme supplements because the enzymes may be contaminated with chloramphenicol.

    Product
    Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Notation: Product #6 Clean Cut Enzyme wasn't entered into RES because the…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0185-2014·2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 24,202 cases of Combiset Blood Lines with BVM for hemodialysis. The recall addresses a risk of blood loss if connections are not tightened correctly.

    Product
    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false occlusion alarms or missed occlusions.

    Product
    *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighNHTSA·13V579000·2013-11-20

    Blue Bird Recalls 2014-2015 School Buses for Seat Belt Defect

    Blue Bird is recalling 2014-2015 Vision and All American school buses because the driver's seat belt latch may fail to release, hindering emergency egress.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0143-2014·2013-11-20

    Apex Energetics Recalls Four Supplements Due to Chloramphenicol Contamination

    Apex Energetics is recalling four dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol from a raw material supplier.

    Product
    LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2014·2013-11-20

    Empirical Labs Recalls Tri-Mins Dietary Supplements Due to Chloramphenicol

    Empirical Labs is recalling specific lots of Tri-Mins Daily Foundation dietary supplements because they may be contaminated with chloramphenicol.

    Product
    Dynamite Specialty Products Tri-Mins Daily Foundation, calcium, magnesium, potassium dietary supplement; 240 Capsules; Manufactured for Dynamite Marketing, Inc, Meridian, ID 83642.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0242-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-0168-2014·2013-11-20

    Oh Bok Bakery Recalls Walnut Cookies for Undeclared Wheat Flour

    Cho & So, Inc. is recalling walnut-shaped soft cookies because wheat flour was not declared on the label, posing a risk to individuals with wheat allergies.

    Product
    Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20644D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 3/20/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0184-2014·2013-11-20

    Fresenius Hemodialysis Blood Lines Recalled for Potential Disconnection Risk

    Fresenius Medical Care is recalling 8,528 cases of 2008K@ Home Blood lines due to a risk of disconnection and blood loss if not tightened correctly.

    Product
    2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2014·2013-11-20

    Toshiba Titan 3T MRI System Recalled for SAR Display Error

    Toshiba is recalling 18 Titan 3T MRI systems because they may display lower Specific Absorption Rate (SAR) values than actual when used with specific coils.

    Product
    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2014·2013-11-20

    Ray Station Radiation Therapy System Recalled for Dose Calculation Error

    Ray Search Laboratories is recalling Ray Station 3.0, 3.5, and 4.0 systems due to a dose calculation error involving Elekta motorized wedges.

    Product
    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0169-2014·2013-11-20

    Oh Bok Bakery Recalls Doughnuts for Undeclared Wheat Allergen

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Korean Cake doughnuts because wheat flour was not declared on the label.

    Product
    Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2014·2013-11-20

    Terumo Recalls Sarns Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0278-2014·2013-11-20

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation

    Medtronic is recalling 64,163 RestoreUltra and RestoreSensor neurostimulators worldwide due to a risk of loss of stimulation when switching program groups.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2014·2013-11-20

    Urologix Recalls Prostiva RF Therapy Hand Piece Kits Due to Deployment Force Issue

    Urologix is recalling 142 Prostiva RF Therapy Hand Piece Kits because the hand piece deployment force exceeded maximum specifications.

    Product
    Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2014·2013-11-20

    DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and patient cross-contamination.

    Product
    DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Pressure Sensor Pin

    Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2014·2013-11-20

    DeRoyal Surgical Eye Spears Recalled for Incorrect X-Ray Detectability Labeling

    DeRoyal Industries is recalling one lot of Surgical Eye Spears because they were labeled as x-ray detectable but contained non-detectable product.

    Product
    DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2014·2013-11-20

    Draeger Ceiling Supply Units Recalled Due to Broken Drive Screw

    Draeger Medical is recalling 139 Movita 603x/DVE 803x Ceiling Supply Units because a broken drive screw caused the lift arm to fall.

    Product
    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2014·2013-11-20

    GE Healthcare Recalls AW Workstations Due to Image Orientation Error

    GE Healthcare is recalling AW VolumeShare and AW Server software due to a potential safety issue where images may display in the wrong orientation after rotation.

    Product
    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2014·2013-11-20

    Beckman Coulter Recalls Access 2 Immunoassay System Due to Fuse Defect

    Beckman Coulter is recalling the Access 2 Immunoassay System because the fuses may have the wrong amperage.

    Product
    Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V578000·2013-11-20

    Mirage Cargo Trailer Recall for Door Lock Jamming Risk

    Mirage is recalling 2006-2013 cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    MIRAGE — MIRAGE CARGO TRAILERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2014·2013-11-20

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Calibration Drift

    Hospira is recalling 179 Plum A+ Hyperbaric Infusion Pumps because distal pressure sensor calibration drift may cause false alarms or occlusions.

    Product
    Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2014·2013-11-20

    Infusion pumps are recalled for distal pressure sensor drift

    Hospira recalled 10,669 Plum A+ infusion pumps after reports of distal pressure sensor calibration drift. The issue may cause false occlusion alarms or distal occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0147-2014·2013-11-20

    Empirical Labs Recalls Vive Shake Up Your Health Chocolate Dietary Supplements

    Empirical Labs is recalling specific lots of Vive Shake Up Your Health Chocolate dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·13V580000·2013-11-20

    Fleetwood Recalls 2014 Recreational Vehicles Due to Seat Belt Latch Issues

    Fleetwood is recalling 774 model year 2014 recreational vehicles because the seat belt latch plate may remain partially engaged, making the belt difficult to unlatch.

    Product
    FLEETWOOD — FLEETWOOD, AMERICAN COACH TIOGA MONTARA, AMERICAN EAGLE, PROVIDENCE, TERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E064000·2013-11-20

    Seats Incorporated Recalls Front Seat Belt Buckle Assemblies

    Seats Incorporated is recalling front seat belt buckle assemblies that may fail to release when the button is pressed, increasing injury risk in a crash.

    Product
    SEAT BELTS:FRONT:BUCKLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling 182,970 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 214 Plum A+3 Infusion Pump Systems because distal pressure sensor calibration drift may cause false alarms or occlusions.

    Product
    Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0159-2014·2013-11-20

    Klaire Labs Vital-Zymes Chewable Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Vital-Zymes Chewable enzyme supplements because they may be contaminated with chloramphenicol.

    Product
    Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·13V577000·2013-11-20

    Blue Bird Recalls 2014 Vision and All American Buses for Seat Belt Defect

    Blue Bird is recalling 146 model year 2014 Vision and All American non-school buses because the driver's seat belt latch plate can become stuck, hindering egress.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin

    Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0164-2014·2013-11-20

    Apotheca Energique Gastrozyme Recalled for Potential Chloramphenicol Contamination

    Grato Inc. is recalling Apotheca Energique Gastrozyme dietary supplements because they may contain chloramphenicol. The product was sold nationwide through retail and internet channels.

    Product
    Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2014·2013-11-20

    Baxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues

    Baxter Healthcare is recalling SIGMA SPECTRUM Infusion Pumps because they may trigger false upstream occlusion or air-in-line alarms during use.

    Product
    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0208-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2014·2013-11-20

    Medtronic Activa Neurostimulators Recalled for Loss of Stimulation

    Medtronic is recalling specific Activa rechargeable neurostimulators because they may lose stimulation when switching programs. Therapy can be restored using the Physician Recharge mode.

    Product
    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo is recalling 30 units of Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0285-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 71 Plum A+ Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0161-2014·2013-11-20

    Klaire Labs Interfase Enzyme Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Interfase enzyme supplements because the enzymes used may be contaminated with chloramphenicol.

    Product
    Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0269-2014·2013-11-20

    Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect

    Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.

    Product
    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0170-2014·2013-11-20

    Oh Bok Bakery Recalls Sweet Bread for Undeclared Wheat Flour

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Sweet Bread (Bam Bbang) because wheat flour was not declared on the label.

    Product
    Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0191-2014·2013-11-20

    DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.

    Product
    DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2014·2013-11-20

    Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin

    Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira Inc. is recalling 182,971 Plum A+ Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0135-2014·2013-11-20

    Specialty Enzymes Recalls Cellulase and Protease Products for Chloramphenicol

    Specialty Enzymes & Biotechnologies is recalling cellulase and protease products because they may contain low levels of chloramphenicol.

    Product
    Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2014·2013-11-20

    Baxter Recalls SIGMA SPECTRUM Infusion Pump LCD Screens for Discharge Failure

    Baxter Healthcare is recalling 346 SIGMA SPECTRUM Infusion Pump LCD screens that failed to withstand electrostatic discharge.

    Product
    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0210-2014·2013-11-20

    Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues

    Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.

    Product
    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0243-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0226-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0272-2014·2013-11-20

    Biotene Moisturizing Mouth Spray Recalled for Incorrect Ingredient Labeling

    GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray because the label lists sorbitol, but the product does not contain it.

    Product
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0127-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. Consumers should check their pantries for the specific affected lot.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0225-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0129-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects 4,512 cases distributed across eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0194-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-0173-2014·2013-11-20

    Torn Ranch Fruit Truffles Recalled for Undeclared Yellow Dyes

    Torn Ranch Inc. is recalling specific fruit truffle flavors because Yellow #5 and #6 dyes were not declared on the label.

    Product
    Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut…
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0245-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0227-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0247-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0256-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0276-2014·2013-11-20

    OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error

    OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.

    Product
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0248-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0223-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0250-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0130-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects 1,942 cases distributed to eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0252-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defects

    Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states

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