BEUDAMED
    FDA Enforcement Class II Terminated

    Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0278-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0278-2017
    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

    Transvaginal Pack, Kit number CMP1767 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 Number/ Expiration Date: 59178 4/13/2015 59934 7/12/2015 65288 11/2/2015 62926 11/10/2015 61866 11/11/2015 66049 11/15/2015 62393 11/28/2015 65692 12/22/2015 63808 1/6/2016 64452 1/17/2016 57606 6/7/2016 66520 7/23/2016 57779 8/10/2016 69057 9/3/2016 59004 9/11/2016 67872 9/30/2016 60067 12/27/2016 69452 1/3/2017 72635 1/9/2017 72687 1/17/2017 72841 3/9/2017 72688 3/22/2017 73048 5/21/2017 74873 5/24/2017 74988 7/16/2017 76993 8/14/2017 77250 9/11/2017 80477 1/9/2018 77808 1/16/2018 67027 (no date was provided)

    Distribution

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

    Quantity

    1780 kits