The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
105
High
243
Moderate
221
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

Which agencies issued them

201–300 of 588

  • SevereFDA (Food)·F-0163-2014·2013-11-20

    Bairn Biologics Candisol Recalled Due to Chloramphenicol Contamination

    Bairn Biologics is recalling Candisol dietary supplements because the xylanase enzyme ingredient was found to be contaminated with Chloramphenicol.

    Product
    Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule. Pac
    Category
    Food
    Distribution
    0 states
  • 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-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 eff
    Category
    Food
    Distribution
    1 state
  • 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
  • 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-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
  • SevereFDA (Food)·F-0149-2014·2013-11-20

    Empirical Labs SuperFuel Tropical Dietary Supplement Recalled for Chloramphenicol

    Empirical Labs is recalling SuperFuel Tropical dietary supplements due to potential adulteration with chloramphenicol. The product was distributed to Idaho, Minnesota, South Carolina, and Sweden.

    Product
    Empirical Labs Building Health SuperFuel Tropical Dietary Supplement
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0280-2014·2013-11-20

    Stryker Recalls Acetabular Pressurizers Due to Cracked Assemblies

    Stryker is recalling 87 boxes of Acetabular Pressurizers because cracked assemblies may release during cement application.

    Product
    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-52
    Category
    Medical Device
    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-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-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
  • SevereFDA (Devices)·Z-0202-2014·2013-11-20

    Synthes 8.5 MM Medullary Reamer Recalled Due to Intraoperative Breakage

    Synthes USA HQ, Inc. is recalling 2,979 units of the 8.5 MM Medullary Reamer because the reamer head can break during surgery, leaving unretrieved fragments of non-implant grade material.

    Product
    Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage
    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
  • 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 (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 (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 (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
  • 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 produc
    Category
    Food
    Distribution
    0 states
  • 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-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-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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-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 infusions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0175-2014·2013-11-20

    GoPicnic Hummus and Crackers Meal Kits Recalled for Undeclared Milk

    GoPicnic is recalling Hummus & Crackers meal kits because the included chocolates may contain undeclared milk allergens.

    Product
    Gopicnic; Hummus & crackers; GoPicnic meal kit packaged in paperboard container. ready-to-eat meal; with professor zim zam's extraordinary sweets dark chocolate with sea salt. NET WT 4.1 OZ (116g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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
  • 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-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-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 (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-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, o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 o
    Category
    Medical Device
    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-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 infusions
    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
  • 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-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-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 (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 infusions
    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-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-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-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 int
    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-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 o
    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 an
    Category
    Medical Device
    Distribution
    26 states
  • 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-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 integrates
    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-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-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 car
    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 varie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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
  • 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 (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-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 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    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 RAD SW ADV CR/DR LAYOUT & VIEW 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-0190-2014·2013-11-20

    Advanced Sterilization Products Recalls Sterrad 100NX Sterilizers Due to Odor Reports

    Advanced Sterilization Products is recalling Sterrad 100NX sterilizers because healthcare workers detected odors, potentially linked to vacuum pump oil breakdown.

    Product
    Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    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/15 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, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0142-2014·2013-11-20

    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
    SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2014·2013-11-20

    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.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K 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, retrie
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0217-2014·2013-11-20

    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; Virtual Access Software, StandAlone 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, retr
    Category
    Medical Device
    Distribution
    26 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 (Food)·F-0141-2014·2013-11-20

    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.

    Product
    GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0165-2014·2013-11-20

    21st Century Recalls Digestive Enzymes Due to Chloramphenicol Contamination

    21st Century Healthcare is voluntarily recalling Digestive Enzymes capsules because raw materials may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Food)·F-0138-2014·2013-11-20

    Metagenics Recalls Spectrazyme Due to Potential Chloramphenicol Contamination

    Metagenics is recalling Spectrazyme supplements because raw materials may contain the antibiotic chloramphenicol. The recall covers products distributed in the US and several international markets.

    Product
    Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0199-2014·2013-11-20

    Anspach Effort Recalls Cutting Bur Chart Due to Labeling Error

    Anspach Effort, Inc. is correcting labeling on its Cutting Bur Chart and related manuals because a claim about cutting biometals was not part of the device's intended use.

    Product
    Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0219-2014·2013-11-20

    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; Virtual Enterprise SW StandAlone 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, retriev
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0216-2014·2013-11-20

    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; Virtual PWR Reading Basic SW 8 Pack 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, retrie
    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 a
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0274-2014·2013-11-20

    SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation

    SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.

    Product
    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2014·2013-11-20

    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.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O 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, retrie
    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, retrie
    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, retrieve
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0218-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    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; Virtual Access Pluse SW, StandAlone 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, retr
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0257-2014·2013-11-20

    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 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, retriev
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0220-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

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

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone 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, re
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0273-2014·2013-11-20

    Nobel Biocare Recalls Osseocare Pro Dental Devices Due to Malfunction Risk

    Nobel Biocare is recalling Osseocare Pro dental consoles because they may malfunction when used with a specific iPad software version.

    Product
    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0234-2014·2013-11-20

    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; MX PRINT SW AUTO LAYOUT PAGE & PRINT 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, retri
    Category
    Medical Device
    Distribution
    26 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 (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, retriev
    Category
    Medical Device
    Distribution
    26 states

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