BEUDAMED
    FDA Enforcement Class II Terminated

    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0190-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0190-2017
    Event ID
    71968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    April 22, 2015
    Classification Date
    October 20, 2016
    Termination Date
    October 25, 2016
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

    Reason

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot Numbers/ Expiration Dates: 59208 11/3/2015 66913 11/9/2015 64949 1/1/2016 63581 1/4/2016 56990 6/19/2016 58800 8/22/2016 68611 9/11/2016 69745 9/17/2016 73553 1/27/2017 70679 3/22/2017 73768 4/11/2017 74539 6/19/2017 75798 9/19/2017 79480 1/2/2018 80615 2/23/2018

    Distribution

    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

    Quantity

    282 kits