BEUDAMED
    FDA Recall Terminated

    Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.

    Recall: Z-0650-2009 · Initiated November 18, 2008

    Recall

    Recall Number
    Z-0650-2009
    Event Number
    50178
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FPP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 18, 2008
    Posted
    February 4, 2009
    Terminated
    October 27, 2010
    Address
    3800 E. Centre Ave., Portage, MI, 49002

    Description

    Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.

    Reason

    Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

    Action

    Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.

    Distribution

    Worldwide Distribution: USA, India, Netherlands and United Kingdom.

    Quantity

    102