BEUDAMED
    FDA Recall Terminated

    Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.

    Recall: Z-3010-2011 · Initiated June 28, 2011

    Recall

    Recall Number
    Z-3010-2011
    Event Number
    59112
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FPP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 28, 2011
    Posted
    August 11, 2011
    Terminated
    August 29, 2013
    Address
    3800 East Centre Ave., Portage, MI, 49002

    Description

    Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.

    Reason

    Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanently engage the track locking mechanism

    Action

    The firm, Stryker Medical, sent an "Urgent-Medical Device Recall" letter dated June 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate the listed product; inspect each unit prior to use; return the enclosed post card to confirm receipt of this notification; if they have loaned or sold any of the chairs listed, forward a copy this letter to the new users and advise Stryker of new users names and locations, and if they have disposed of any of the affected chairs and they are no longer in use, advise Stryker of their obsolescence by providing them with the serial numbers. Stryker stated in the letter that, their goal is the timely upgrade of all affected units within the next 90 days. If you have any questions or concerns, please contact us at 800-STRYKER, option 2. Please reference RA-2011-027. Normal business hours are Monday-Friday 8am-5pm EST.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.

    Quantity

    220