BEUDAMED
    FDA Enforcement Class II 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 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1210-2014
    Event ID
    67686
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    February 21, 2014
    Classification Date
    March 14, 2014
    Termination Date
    May 8, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    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

    Code Info

    lot numbers 1143442 and 1161762

    Distribution

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

    Quantity

    8,962 pairs