BEUDAMED
    FDA Enforcement Class II Terminated

    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0208-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0208-2017
    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

    Hernia Pack, Kit number AMS1519 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: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014 64165 9/14/2014 65059 9/27/2014 67591 9/29/2014 68544 5/7/2015 68386 5/24/2015 68720 9/14/2015 70550 10/8/2015 69342 10/17/2015 74095 12/2/2015 73780 12/23/2015 76033 2/22/2016 76082 2/22/2016 72977 2/25/2016 76032 2/27/2016 56835 5/29/2016

    Distribution

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

    Quantity

    765 kits