BEUDAMED
    FDA Recall Terminated

    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.

    Recall: Z-1472-2008 · Initiated February 21, 2008

    Recall

    Recall Number
    Z-1472-2008
    Event Number
    46904
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 21, 2008
    Posted
    September 23, 2008
    Terminated
    October 28, 2008
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.

    Reason

    Lithium batteries may fail if the glucose or creatinine meters have been dropped.

    Action

    Nova Biomedical notified consignees by telephone and followed by the Recall Notification letter for the Vata Easy Pack XL Lithium Polymer Battery, dated 2/2108 and mailed 2/26/08. Users are notified of the problem with the battery in the Nova Stat Strip Blood Glucose Hospital Meter System and is replacing batteries by on site visit. E-Z-EM , Inc. notified their customers by letter dated 3/17/08. Contact Nova Biomedical Corporation at 1-800-545-6682 for assistance.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.

    Quantity

    4432 batteries