BEUDAMED
    FDA Enforcement Class II Terminated

    Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0148-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0148-2017
    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

    Basic Setup Pack, kit part number AMS1787(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 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 69999 10/2/2016 70654 10/11/2016 71789 12/10/2016 72154 3/8/2017 73836 5/16/2017 75272 7/18/2017 76643 7/1/2017 77304 10/8/2017 78543 8/30/2017

    Distribution

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

    Quantity

    256 kits