BEUDAMED
    FDA Recall Terminated

    Stryker Medical Stretcher Model 1105 Prime 5th Wheel A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    Recall: Z-2927-2011 · Initiated July 19, 2011

    Recall

    Recall Number
    Z-2927-2011
    Event Number
    59214
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    INK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 19, 2011
    Posted
    August 3, 2011
    Terminated
    August 28, 2013
    Address
    3800 East Centre Ave., Portage, MI, 49002

    Description

    Stryker Medical Stretcher Model 1105 Prime 5th Wheel A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    Reason

    Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

    Action

    Stryker Medical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.

    Quantity

    23