BEUDAMED
    FDA Enforcement Class II Terminated

    Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0185-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0185-2017
    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

    Extremity Tray, Kit number AMS1200(B and AMS1200(C 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: 59843 3/1/2015 60753 8/17/2015 59894 9/6/2015 65996 11/13/2015 61600 11/28/2015 62117 12/12/2015 64160 1/3/2016 69211 5/5/2016 56959 6/8/2016 57789 7/1/2016 67355 7/5/2016 58586 8/27/2016 69588 10/8/2016 70509 1/6/2017 72551 1/10/2017 76068 7/17/2017 77502 7/17/2017 78140 9/19/2017

    Distribution

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

    Quantity

    816 kits