BEUDAMED
    FDA Enforcement Class II Terminated

    Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0243-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0243-2017
    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

    Minor Tray AMS2685 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: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952 3/12/2017 73688 4/5/2017 73599 4/20/2017 74550 5/7/2017 74782 5/22/2017 75650 7/29/2017 80441 8/9/2017 78329 9/23/2017 76679 10/4/2017 78742 1/4/2018

    Distribution

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

    Quantity

    600 kits