BEUDAMED
    FDA Recall Terminated

    Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.

    Recall: Z-0863-2012 · Initiated November 1, 2011

    Recall

    Recall Number
    Z-0863-2012
    Event Number
    60180
    Firm
    Gunnell, Inc.
    FEI Number
    3009255757
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 1, 2011
    Posted
    January 25, 2012
    Terminated
    August 29, 2013
    Address
    8440 State Rd, Millington, MI, 48746-9445

    Description

    Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.

    Reason

    Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.

    Action

    Gunnell, Inc. sent a Medical Device Correction letters dated November 1, 2011 to all consignees. The letter identified the product, problem, and actions to be taken. The letter states that Gunnell Inc will provide free replacement cylinders and reimburse for each correction verified. The notice instructs customers to complete and return the Response Form. Customers were instructed to notify their customers by including a copy of the correction notice. Question and concerns should be addressed to [email protected]. or call 1-800-551-0055, attention Andy Evancho.

    Distribution

    Worldwide Distribution - USA (nationwide) nad the countries of: Australia and Canada

    Quantity

    23 (22 listed)