BEUDAMED
    FDA Enforcement Class II Terminated

    Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0221-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0221-2017
    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

    Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015 63414 1/30/2016 66908 11/26/2015 67932 4/9/2016 68546 6/11/2016 71757 9/7/2016 72106 9/2/2016 72622 8/25/2016 73283 8/5/2016 73423 8/13/2016 73765 8/2/2016 74067 8/16/2016 74310 12/8/2016 75360 2/4/2017

    Distribution

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

    Quantity

    230 kits