BEUDAMED
    FDA Recall Terminated

    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.

    Recall: Z-0650-2014 · Initiated October 10, 2013

    Recall

    Recall Number
    Z-0650-2014
    Event Number
    66398
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 10, 2013
    Posted
    January 9, 2014
    Terminated
    March 24, 2014
    Address
    200 Prospect St, Waltham, MA, 02453

    Description

    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.

    Reason

    Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage

    Action

    On November 18, 2013, an URGENT Field Correction Letter was sent to all StatStrip Glucose Hospital meter, StatStrip Lactate Hospital Meter and StatSensor Creatinine Hospital Meter customers via email to the Point of Care Coordinator to alert users that lithium batteries that are utilized beyond their intended useful life may swell and/or crack posing a potential safety hazard. In some cases, the swelling may potentially cause the battery door on the meter to dislodge and render the meter inoperable.

    Distribution

    Nationwide Distribution.

    Quantity

    est. 200,000