BEUDAMED
    FDA Enforcement Class II 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 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0650-2014
    Event ID
    66398
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nova Biomedical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2014
    Initiation Date
    October 10, 2013
    Classification Date
    January 9, 2014
    Termination Date
    March 24, 2014
    Address
    200 Prospect St, Waltham, MA, 02453, United States

    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

    Code Info

    All serial numbers

    Distribution

    Nationwide Distribution.

    Quantity

    est. 200,000