BEUDAMED
    FDA Enforcement Class II Terminated

    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0182-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0182-2017
    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

    ENT Tray, Kit number AMS1195(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: 59841 7/3/2015 59998 7/22/2015 60492 9/12/2015 61308 9/24/2015 64554 10/19/2015 65916 11/1/2015 65449 11/2/2015 62451 11/6/2015 65563 11/9/2015 63498 11/11/2015 66317 11/12/2015 66528 11/27/2015 62114 11/30/2015 64157 1/7/2016 63818 1/24/2016 68366 7/12/2016 67034 7/15/2016 57296 7/25/2016 78780 7/30/2016 66529 8/26/2016 59011 8/28/2016 69786 9/7/2016 70822 9/13/2016 69209 10/10/2016 71824 12/10/2016 72548 1/17/2017 72194 1/31/2017 73166 3/7/2017 73705 4/2/2017 74465 5/7/2017 74906 5/30/2017 75575 7/3/2017 75725 7/8/2017 76499 7/21/2017 75890 7/29/2017 79088 9/27/2017 76846 10/5/2017

    Distribution

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

    Quantity

    1795 kits