BEUDAMED
    FDA Recall Terminated

    Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.

    Recall: Z-2240-2011 · Initiated April 29, 2011

    Recall

    Recall Number
    Z-2240-2011
    Event Number
    58487
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    IKY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2011
    Posted
    May 23, 2011
    Terminated
    October 7, 2011
    Address
    3800 East Centre Ave., Portage, MI, 49002

    Description

    Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.

    Reason

    Affected mattresses may not conform to federal flammability standards.

    Action

    Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689.

    Distribution

    Worldwide Distribution - USA including California and the country of Canada.

    Quantity

    213