BEUDAMED
    FDA Enforcement Class II Completed

    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 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0809-2013
    Event ID
    64110
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    CHENICA INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    January 18, 2013
    Classification Date
    February 13, 2013
    Termination Date
    April 15, 2014
    Address
    50 Enterprise Dr, Vassar, MI, 48768-9504, United States

    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).

    Code Info

    Serial Numbers: 36977-1210, 37194-0312, 37455-1111, 37606-0312, 36988-1210, 37220-0511, 37484-1111, 37614-0312, 36999-1210, 37234-0511, 37495-1211, 37628-0312, 37000-1210, 37273-0611, 37497-0711, 37632-0312, 37003-1210, 37305-0711, 37515-1211, 37633-0312, 37014-1210, 37307-0711, 37520-1211, 37636-0312, 37061-0211, 37333-0711, 37521-1211, 37637-0411, 37067-0111, 37348-0811, 37523-1211, 37675-0412, 37094-0211, 37374-0911, 37537-0112, 37681-0412, 37114-0211, 37393-0911, 37555-0112, 37286-0511, 37122-0211, 37394-0911, 37576-0212, 37296-0611, 37137-0311, 37440-1011, 37584-0212, 37141-0311, 37448-1011, 37594-0212, 37185-0311, 37449-1011, 37601-0312.

    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