BEUDAMED
    FDA Enforcement Class II Terminated

    DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

    Recall: Z-2125-2014 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2125-2014
    Event ID
    68744
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2014
    Initiation Date
    June 4, 2014
    Classification Date
    July 29, 2014
    Termination Date
    May 5, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703, United States

    Description

    DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

    Reason

    The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

    Code Info

    Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

    Distribution

    Distributed in the states of MI, GA, OH, IL, MO, and IN.

    Quantity

    230 units