BEUDAMED
    FDA Recall Terminated

    IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.

    Recall: Z-1946-2013 · Initiated July 12, 2013

    Recall

    Recall Number
    Z-1946-2013
    Event Number
    65337
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    IOQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 12, 2013
    Posted
    August 9, 2013
    Terminated
    September 11, 2014
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.

    Reason

    Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi

    Action

    On 7/12/13, an URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees. The notification addressed the affected product and issue, potential hazard, actions needed including faxing (269-488-8691) or emailing ([email protected]) the attached reply form to confirm receipt of notification, and risk mitigation. Please contact the firm at 269-389-8129 if you have questions or concerns regarding this recall. Business hours are M-F 8am-5pm(ET).

    Distribution

    Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.

    Quantity

    586 units