BEUDAMED
    FDA Recall Terminated

    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

    Recall: Z-1210-2014 · Initiated February 21, 2014

    Recall

    Recall Number
    Z-1210-2014
    Event Number
    67686
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    FMQ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 21, 2014
    Posted
    March 14, 2014
    Terminated
    May 8, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

    Reason

    Moldy smell in product

    Action

    DeRoyal initiated an Urgent Voluntary Recall dated February 21, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. DeRoyal has asked that products be destroyed, and that notice of destruction be sent back. For questions contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.

    Quantity

    8,962 pairs