The Recall Desk

Archive

July 2012 recalls

445 recalls were announced in July 2012.

What the numbers show

Critical
14
Severe
94
High
219
Moderate
91
Low
27

Of the 445 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

101–200 of 445

  • HighNHTSA·12V338000·2012-07-19

    Honda Recalls 2012 CR-V and 2013 Acura ILX for Door Latch Defect

    Honda is recalling 2012 CR-V and 2013 Acura ILX vehicles because a door latch cable may loosen, preventing the door from latching properly and increasing injury risk.

    Product
    ACURA — ACURA, HONDA ILX, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1752-2012·2012-07-18

    Pro Nutech Recalls Light Dry Roasted Unsalted Split Peanuts Due to Salmonella Risk

    Pro Nutech Inc. is recalling 103,280 lbs of Light Dry Roasted Unsalted Split Peanuts because they may be contaminated with Salmonella Typhimurium from a supplier.

    Product
    Light Dry Roasted Unsalted Split Peanuts, Product Code: 400260, packaged in 30 lb. vacuum packed plastic bags placed inside cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1758-2012·2012-07-18

    Pacific International Marketing Recalls Romaine Lettuce Due to Salmonella

    Pacific International Marketing is recalling romaine lettuce tied with a rubber band due to a positive field test for Salmonella. The product was distributed in California and Nevada.

    Product
    Romaine Lettuce tied with a rubber band
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1737-2012·2012-07-18

    Henry's Farm Soybean Sprouts Recalled for Listeria Contamination

    Henry's Farm Inc. is recalling soybean sprouts due to potential Listeria monocytogenes contamination. The product was distributed in Maryland, Virginia, and Washington, D.C.

    Product
    Sprouts, Soybean, packed in clear plastic 1.0 lb and 1.5 lb. bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580*** and also bulk packaged in unlabeled 10 lb black plastic bags.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1735-2012·2012-07-18

    Dole Hearts of Romaine Recalled Due to Listeria Monocytogenes Contamination

    Dole Fresh Vegetables Inc is recalling specific lots of Dole brand Hearts of Romaine because an FDA sample tested positive for Listeria monocytogenes.

    Product
    Dole brand Hearts of Romaine; Net Wt. 10 oz. UPC 71430 00956; Dole
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1751-2012·2012-07-18

    Pro Nutech Peanut Granules Recalled Due to Salmonella Contamination Risk

    Pro Nutech Inc. is recalling Medium Chopped Peanut Granules because they may be contaminated with Salmonella Typhimurium from a supplier implicated in a salmonellosis outbreak.

    Product
    Medium Chopped Peanut Granules, Product Code #410016, packaged in 30 lb. vacuum packed plastic bags within cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1763-2012·2012-07-18

    Banner Mountain Sprouts Recalled Due to Salmonella Contamination

    Banner Mountain Sprouts is recalling alfalfa sprouts after USDA sampling found Salmonella. Consumers should discard or return the product.

    Product
    Banner Mountain Sprouts; Clover Sprouts: California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz and 1 lb containers; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 96911 72843 0; UPC - 1 lb size: 0 96
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1734-2012·2012-07-18

    LEASA Living Alfalfa Sprouts Recalled Due to Salmonella Contamination

    LEASA Industries is recalling 6 oz containers of Living Alfalfa Sprouts with a Use By Date of 07/02/2012 after a sample tested positive for Salmonella.

    Product
    Product is labeled in part: "***LEASA Living Alfalfa Sprouts***CHOLESTEROL FREE***PRESERVATIVE FREE***KEEP REFRIGERATED***NET WT. 6 OZ. (168 g)***" Product is packaged in 6 oz clear plastic containers with UPC 75465-55912. UPC Code and expiration date are located on the
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1446-2012·2012-07-18

    Dole Recalls Kroger Fresh Selections Greener Supreme Salad for Listeria Risk

    Dole Fresh Vegetables Inc is recalling Kroger Fresh Selections Greener Supreme salad due to a positive Listeria monocytogenes sample.

    Product
    Kroger Fresh Selections Greener Supreme; Iceberg lettuce, Romaine lettuce, Carrots and Red Cabbage; 12 oz plastic bag. Best if used by date: June 19, 2012: UPC 0 11110 91039 4 Distributed by the Kroger Co., Cincinnati, OH 45202
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1738-2012·2012-07-18

    Henry's Farm Natto Soybean Sprouts Recalled for Listeria Contamination

    Henry's Farm Inc. is recalling Natto Soybean Sprouts due to potential Listeria monocytogenes contamination. The product was distributed in Maryland, Virginia, and Washington, D.C.

    Product
    Sprouts, Natto Soybean, packed in clear plastic 1.0 lb bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580***
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1980-2012·2012-07-18

    Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

    Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.

    Product
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1726-2012·2012-07-18

    Wanchese Fish Company Recalls Oysters Due to Insanitary Conditions

    Wanchese Fish Company is recalling IQF Select oysters from South Korea because they were packed or held under insanitary conditions.

    Product
    Oysters, IQF Select, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435***Product of S Korea***
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1736-2012·2012-07-18

    Fruiti Pops Coconut Ice Bars Recalled for Potential Egg Yolk Contamination

    Fruiti Pops Inc. is recalling 178 dozens of 4 oz. Coconut Ice Bars because the product may contain egg yolk. The items were distributed in Southern California.

    Product
    Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:" Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI POPS 15418 CORNET SANTA FE SPRINGS, CA 90670 PLANT NO. 06-4562***".
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1761-2012·2012-07-18

    Banner Mountain Sprouts Recalls Organic Sprouts Due to Salmonella

    Banner Mountain Sprouts is recalling organic sprouts after USDA sampling found Salmonella. Consumers should discard the product.

    Product
    Banner Mountain Sprouts;Zesty Greens - Clover, Radish; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 96911 72845 4;
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1415-2012·2012-07-18

    Kleenex Foam Hand Sanitizer Recalled for Microbial Contamination

    Kimberly-Clark is recalling specific lots of Kleenex Foam Hand Sanitizer, Alcohol Free, due to contamination with Burkholderia cepacia complex.

    Product
    Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2012·2012-07-18

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Impurities

    VistaPharm is recalling specific lots of Hydrocodone Bitartrate & Acetaminophen Oral Solution because impurities exceeded specifications during stability testing.

    Product
    Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1760-2012·2012-07-18

    Banner Mountain Alfalfa Broccoli Sprouts Recalled for Salmonella

    Banner Mountain Sprouts Inc is recalling Alfalfa Broccoli Sprouts after USDA sampling found Salmonella. Consumers should discard the product.

    Product
    Banner Mountain Sprouts;Alfalfa Broccoli Sprouts; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9691172840 9;
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1749-2012·2012-07-18

    Mutual Trading Recalls Cod Fish with Miso for Undeclared Soy

    Mutual Trading Company Inc is recalling F-Tara Saikyozuke (Cod Fish with miso) because it contains undeclared soy.

    Product
    F-Tara Saikyozuke (Cod Fish with miso), 3.1lb., 20pc.x ab.2.5oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1750-2012·2012-07-18

    Pacific Giant Recalls Korean Frozen Oysters Due to Insanitary Conditions

    Pacific Giant is recalling specific lots of Ocean Manna Korean frozen oysters because they were prepared or packed under insanitary conditions that may have caused contamination.

    Product
    Ocean Manna Korean IQF Oysters, sizes: Tiny, Medium, Large. Packed: 40x8oz, 10x2lbs, 2lbs, 6x4lbs, 10x4lbs, 30x1lb, 6x5lbs. Item Code: FO/HMART-2LB, FO/HMART-1LB, FO/HMART-8OZ, FO/HMART-5LB, FO/HS-OHS144, FO/LP-OL6X4, FO/HS-0L4, FO/KO-OM4, FO/HS-OM4, FO/LP-OS8, FO/HS-OT8, HS-
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V335000·2012-07-18

    Texas Pride DTFLB Trailers Recalled for Brake Actuator Defect

    Texas Pride is recalling 2012 DTFLB trailers because improperly heat-treated brake actuator pumps may fail, increasing crash risk.

    Product
    TEXAS PRIDE — TEXAS PRIDE DTFLB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1983-2012·2012-07-18

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.

    Product
    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1739-2012·2012-07-18

    Wang Globalnet Recalls Frozen Oysters Due to Insanitary Conditions

    Wang Globalnet is recalling Surasang Chanbada Frozen Oyster IQF because it was prepared under insanitary conditions that may have contaminated the product.

    Product
    Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1981-2012·2012-07-18

    Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

    Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.

    Product
    Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and ro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2012·2012-07-18

    Trizivir Tablets Recalled Due to Potential Foreign Tablet Contamination

    GlaxoSmithKline is recalling Trizivir tablets because they may contain foreign Lexiva tablets. Patients should stop using the affected lot and contact their healthcare provider.

    Product
    Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V337000·2012-07-18

    Prevost Recalls 2011-2013 X3-45 and XLII-45 Buses for Fire Risk

    Prevost is recalling 293 model year 2011-2013 X3-45 and XLII-45 Entertainer buses because a power cable may rub against sharp edges, potentially causing a short-circuit or fire.

    Product
    PREVOST — PREVOST X3-45, XLII-45 ENTERTAINER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V336000·2012-07-18

    Ford Recalls 2013 Escape Vehicles Due to Fuel Line Fire Risk

    Ford is recalling 2013 Escape vehicles with 1.6L engines because a fuel line may split and leak, increasing the risk of fire or injury.

    Product
    FORD — FORD ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1727-2012·2012-07-18

    Wanchese Fish Company Recalls Breaded Oysters Due to Insanitary Conditions

    Wanchese Fish Company is recalling breaded oysters because they were processed under insanitary conditions or may have been contaminated with filth.

    Product
    Oysters, Breaded IQF, 20-25 count, packed in 2 lb polyethylene bags, 5 bags/carton, and labeled in part ***Wanchese Fish Company, 2000 Northgate Commerce Parkway Suffolk, VA 23435***Product of S Korea***
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1725-2012·2012-07-18

    Wanchese Fish Company Recalls Oysters Due to Insanitary Conditions

    Wanchese Fish Company is recalling IQF oysters from South Korea because they were processed under insanitary conditions or may be contaminated with filth.

    Product
    Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435*** Product of S Korea***
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1746-2012·2012-07-18

    Winter Garden Quality Foods Recalls New England Clam Chowder Due to Temperature Issue

    Winter Garden Quality Foods is recalling New England Clam Chowder due to a possible processing temperature issue during production.

    Product
    New England Clam Chowder 2338 Net Weight 4-4LBS. KEEP REFRIGERATED Packed by Winter Garden Quality Foods, Inc. 304 Commerce St, New Oxford, PA New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1762-2012·2012-07-18

    Banner Mountain Sprouts Recalls Alfalfa Sprouts Due to Salmonella

    Banner Mountain Sprouts is recalling specific lots of alfalfa sprouts after USDA sampling found Salmonella. Consumers should check sell-by dates and discard affected products.

    Product
    Banner Mountain Sprouts; Sprout Salad: Alfalfa, Peas, Garbanzo, Adzuki, Lentil, Clover, Radish; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1966-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 632 System 1 Base units because the backup battery depletes faster than expected, potentially causing unexpected system shutdowns.

    Product
    System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1977-2012·2012-07-18

    Abbott i-Stat Analyzer Recall for Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.

    Product
    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2012·2012-07-18

    Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms

    Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.

    Product
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical proce
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1742-2012·2012-07-18

    Assi Brand Korean Oysters Recalled for Insanitary Conditions

    Korean Farm, Inc. is recalling Assi Brand oysters because they were prepared under insanitary conditions, posing a risk of contamination with filth.

    Product
    IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Brand, item# 20086, 40x8 oz; IQF Oysters 20 oz - Tiny, Assi Brand, item#20093, 20x20 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2012·2012-07-18

    GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues

    GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.

    Product
    GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12226·2012-07-18

    Panline USA Recalls Little Jumpers Trampolines Due to Fall Hazard

    Panline USA is recalling about 8,000 Alex Model 786X Little Jumpers Trampolines because the handlebar can break, creating a fall hazard.

    Product
    Alex ® Model 786X Little Jumpers Trampoline
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 993 Advanced Perfusion System 1 units because the battery may deplete faster than expected during shutdown, potentially causing unexpected system failure.

    Product
    System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional wh
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1954-2012·2012-07-18

    CIVCO General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part nu
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1949-2012·2012-07-18

    Arjo Sara Plus Patient Lifter Recalled for Exposed Metal Bracket Injury Risk

    ArjoHuntleigh is recalling Sara Plus Mobile Patient Lifters because removing the knee pad assembly exposes a metal support bracket, posing an injury risk.

    Product
    Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2012·2012-07-18

    ArjoHuntleigh Recalls Chorus Mobile Patient Lifters Due to Injury Risk

    ArjoHuntleigh is recalling specific Chorus Mobile Patient Lifters because an exposed metal support bracket can cause injuries when the knee pad assembly is removed.

    Product
    Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2012·2012-07-18

    superDimension Systems Software Recall Due to Locatable Guide Malfunction

    superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.

    Product
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12227·2012-07-18

    Samuel Lawrence Furniture Recalls Bordeaux Sleigh Beds Due to Fall Hazard

    Samuel Lawrence Furniture is expanding a recall of Bordeaux Collection sleigh beds because the headboard or footboard hardware can loosen or detach, posing a fall hazard.

    Product
    Full- and Twin-Size Bordeaux Collection Bed Frames
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during procedures.

    Product
    System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2012·2012-07-18

    Abbott i-STAT1 Abaxis Analyzer Recalled for Overheating Battery Area

    Abbott Point of Care is recalling i-STAT1 Abaxis Analyzers because the battery area can become uncomfortably hot to touch.

    Product
    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2012·2012-07-18

    Alere Triage Cardiac Panel Recalled for Decreased Precision

    Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause false positive or negative results.

    Product
    Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2012·2012-07-18

    Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure

    Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.

    Product
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1956-2012·2012-07-18

    Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error

    Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.

    Product
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1989-2012·2012-07-18

    GE Axcess Cranial Screw Recalled Due to Breakage During Insertion

    GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.

    Product
    The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1928-2012·2012-07-18

    Alere Triage CardioProfiler Panel Recalled for Decreased Precision

    Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause false positive or negative results.

    Product
    Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2012·2012-07-18

    Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.

    Product
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1753-2012·2012-07-18

    Sienna Bakery Cookies Recalled for Undeclared Walnut Allergen

    Best Maid Cookie Company is recalling Sienna Bakery cookies due to a potential mis-pack that may result in undeclared walnut allergens.

    Product
    Sienna Bakery¿ White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY LECITHIN
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1952-2012·2012-07-18

    Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.

    Product
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the l
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-1414-2012·2012-07-18

    Kleenex Luxury Foam Hand Sanitizer Recalled for Microbial Contamination

    Kimberly-Clark is recalling specific lots of Kleenex Luxury Foam Hand Sanitizer found to be contaminated with Burkholderia cepacia complex.

    Product
    Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2012·2012-07-18

    Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results

    Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.

    Product
    Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2012·2012-07-18

    Atom Medical Infant Incubator Model 100 Recalled for Canopy Movement

    Atom Medical Corporation is recalling 377 Dual Incu i infant incubators because the canopy may move unintentionally during use.

    Product
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1968-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump occlusion malfunctions that could prevent pump use.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2012·2012-07-18

    Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating

    Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.

    Product
    Drager PT 4000 Phototherapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2012·2012-07-18

    GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues

    Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.

    Product
    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1759-202·2012-07-18

    Banner Mountain Alfalfa Sprouts Recalled Due to Salmonella Contamination

    Banner Mountain Sprouts Inc is recalling alfalfa sprouts after USDA sampling detected Salmonella. Consumers in California should discard the product.

    Product
    Banner Mountain Sprouts;Alfalfa Sprouts; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; 1 lb and 2 lb packages. Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9691172842 3; UPC 1 lb size: 0
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1930-2012·2012-07-18

    Alere Triage Profiler SOB Panel Recalled for Decreased Precision

    Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.

    Product
    Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2012·2012-07-18

    Impac Medical MOSAIQ Oncology System Recall for Wedge Motor Unit Error

    Impac Medical is recalling MOSAIQ Oncology Information Systems due to a software error that incorrectly resets remaining Wedge Motor Units to zero after a machine fault.

    Product
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1947-2012·2012-07-18

    Arjo Encore Mobile Patient Lifter Recalled for Exposed Metal Bracket Injury Risk

    ArjoHuntleigh is recalling specific Encore Mobile Patient Lifters because removing the knee pad assembly can expose a metal support bracket, posing an injury risk to patients.

    Product
    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2012·2012-07-18

    Philips Intellispace Portal software recalled for tumor measurement errors

    Philips Medical Systems is recalling Intellispace Portal software because tumor measurements are not recalculated when lesion contours are edited.

    Product
    Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1728-2012·2012-07-18

    Rhee Brothers Frozen Boiled Baby Clams Recalled for Norovirus Contamination

    Rhee Brothers Incorporated is recalling frozen boiled baby clams from South Korea due to potential Norovirus contamination. The product was distributed nationwide.

    Product
    Clams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2012·2012-07-18

    Stryker Definition PM Femoral Hip Stem Recalled for PMMA Coating Cracking

    Stryker Howmedica Osteonics is recalling 16,913 Definition PM Femoral Hip Stems due to potential cracking of the PMMA coating. The devices were distributed nationwide.

    Product
    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Ced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1756-2012·2012-07-18

    Inventure Foods Recalls Onion Rings and Mozzarella Sticks for Metal Particles

    Inventure Foods is recalling onion rings and mozzarella sticks due to potential tiny metal particles in the seasoning.

    Product
    Onion Rings, 2 oz, 3oz., 6.53 oz & 13 oz.. Burger King Brand, item#41016, 41105, 41121. T.G.I.F Brand, item#41130, 30587, 30587B, 30614, 30845A, 31124, 31125.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2012·2012-07-18

    Abbott i-Stat Analyzers Recalled Due to Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Model 200 and 300 analyzers because they may become uncomfortably hot to touch near the battery.

    Product
    iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arteria
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 992 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2012·2012-07-18

    Alere Triage D-dimer Kits Recalled for Decreased Precision

    Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.

    Product
    Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2012·2012-07-18

    Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect

    Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.

    Product
    Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1953-2012·2012-07-18

    Civco General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part numb
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1967-2012·2012-07-18

    Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk

    Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.

    Product
    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular invol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1757-2012·2012-07-18

    Inventure Foods Recalls Mozzarella Sticks and Onion Rings Due to Metal Particles

    Inventure Foods is recalling specific kits of mozzarella sticks and onion rings because they may contain tiny metal particles in the seasoning.

    Product
    Kit item #30699-76, includes Mozzarella Sticks, 2.25 oz, 12bags/kit; Cheddar Bacon Skins, 3oz, 24 bags/kit; and Sour Cream & Onion Skins 3oz, 12bags/kit. kit item#30679-11, 30679-12, and 30679-13, includes Mozzarella Sticks 2.25oz, 12bags/kit, Cheddar bacon skins 3oz, 24 bags/
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1754-2012·2012-07-18

    Sienna Bakery Cookies Recalled for Undeclared Walnut Allergen

    Best Maid Cookie Company is recalling Sienna Bakery Oatmeal Walnut Raisin cookies because they may be packed in boxes labeled for a different product, resulting in an undeclared walnut allergen.

    Product
    Sienna Bakery¿ Oatmeal Walnut Raisin Gourmet Cookies, UPC 093901165992, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, RAISINS, BROWN SUGAR, OATS, WALNUTS, BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTO
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1755-2012·2012-07-18

    Inventure Foods Recalls T.G.I. Friday's Mozzarella Sticks for Metal Particles

    Inventure Foods is recalling T.G.I. Friday's Mozzarella Sticks because tiny metal particles may be present in the seasoning.

    Product
    T.G.I. Friday's Mozzarella Sticks 2.25oz, 3.5oz, and 4.8 oz. Item#30187, 30588, 30588B, 30707, 30819, 30834.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1447-2012·2012-07-18

    Dole Recalls Romaine Lettuce Due to Listeria Monocytogenes Contamination

    Dole Fresh Vegetables Inc is recalling specific lots of Romaine Lettuce sold as Kroger Fresh Selections and Marketside brands due to a positive Listeria Monocytogenes sample.

    Product
    Leafy Romaine; Romaine Lettuce & Leaf Lettuces; 10 oz plastic bag. Best if used by date: June 19, 2012. Packaged under brand names of: Kroger Fresh Selections, UPC 0 11110 91046 2, Distributed by the Kroger Co., Cincinnati, OH 45202 and Marketside UPC: 6 81131 02781
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1747-2012·2012-07-18

    Giusto's Wheat Germ Recalled Due to Metal Fragment Contamination

    Giusto's Specialty Foods LLC is recalling 25 lb bags of raw wheat germ because the product is contaminated with metal fragments.

    Product
    Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag; Item number: 154205 Giusto's 344 Littlefield Ave. South Francisco, CA 94080
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1974-2012·2012-07-18

    Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery

    Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.

    Product
    i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1741-2012·2012-07-18

    Coca-Cola Cherry Zero Recalled for Mislabeling Sugar Content

    Coca-Cola Refreshments USA is recalling 119 cases of Coca Cola Cherry Zero in Texas because the label incorrectly states the product is sugar-free.

    Product
    Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1979-2012·2012-07-18

    Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units

    Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.

    Product
    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1731-2012·2012-07-18

    Fertalin tablets recalled for unapproved synthetic botanical ingredients

    H & L Jerch Sales, Inc. is recalling Fertalin tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.

    Product
    Fertalin bottles of 90 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #8
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2012·2012-07-18

    Integra Pudenz Flushing Valve Recalled for Incorrect Labeling

    Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.

    Product
    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1978-2012·2012-07-18

    Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery Area

    Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch.

    Product
    Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1963-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall

    Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2012·2012-07-18

    PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps

    PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.

    Product
    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2012·2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1975-2012·2012-07-18

    Abbott i-Stat Analyzers Recalled for Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Analyzers because they can become uncomfortably hot to touch in the battery area.

    Product
    Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2012·2012-07-18

    Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.

    Product
    System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2012·2012-07-18

    CIVCO General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose s
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1962-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall for Flow Control Issues

    Terumo is recalling 1,095 units of the Advanced Perfusion System 1 Electronic O2 Blender/Analyzer due to reported difficulty adjusting the local flow control knob.

    Product
    Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide
    Category
    Medical Device
    Distribution
    Distributed nationwide

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