BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2125-2014 · Initiated June 4, 2014

    Recall

    Recall Number
    Z-2125-2014
    Event Number
    68744
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    June 4, 2014
    Posted
    July 29, 2014
    Terminated
    May 5, 2015
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    The recall was initiated by letter delivered via UPS on 6/4/2014. The firm requested that the consignee contact Stericycle to arrange for return and replacement of the product. A second notice was sent on 7/22/2014 to those accounts who did not respond to the initial notice. Distributors were requested to notify their end-users or provide a list of end-users to DeRoyal for direct notification. Effectiveness checks will be sent via email for those customers who have provided an email contact and via UPS for those customers who have not responded.

    Distribution

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

    Quantity

    230 units