BEUDAMED
    FDA Recall Terminated

    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

    Recall: Z-0809-2013 · Initiated January 18, 2013

    Recall

    Recall Number
    Z-0809-2013
    Event Number
    64110
    Firm
    CHENICA INC.
    FEI Number
    3009255757
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    January 18, 2013
    Posted
    February 13, 2013
    Terminated
    April 15, 2014
    Address
    50 Enterprise Dr, Vassar, MI, 48768-9504

    Description

    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

    Reason

    The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).

    Action

    Gunnell Inc. sent a "RE: URGENT MEDICAL DEVICE CORRECTION/RECALL" letter dated January 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm 1-800-551-0055 for questions relating to this letter.

    Distribution

    Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.

    Quantity

    53