BEUDAMED
    FDA Enforcement Class II Terminated

    Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0263-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0263-2017
    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

    Plastic Pack , Kit number AMS1833(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 Number/ Expiration Date: 58987 3/10/2014 65124 6/13/2014 63594 6/30/2014 65383 7/3/2014 67936 9/16/2014 68657 9/20/2014 67280 9/27/2014 76180 6/10/2016 57602 6/18/2016 78529 7/30/2016 59242 8/27/2016 80645 11/19/2016

    Distribution

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

    Quantity

    204 kits