BEUDAMED
    FDA Enforcement Class II Terminated

    Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0150-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0150-2017
    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

    Basin Pack, kit number AMS2497 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: 67015 7/5/2016 67549 8/10/2016 68418 7/7/2016 68820 9/19/2016 68959 9/12/2016 69548 9/20/2016 69852 10/23/2016 70495 10/20/2016 71780 12/11/2016 71957 10/20/2016 71958 1/7/2017 72481 3/15/2017 73643 1/22/2017 73644 4/10/2017 73850 4/23/2017 74062 7/9/2017 76185 7/11/2017 76345 8/31/2017 76673 10/21/2017 77769 10/4/2017 78025 9/22/2017 78741 1/17/2018 80940 8/8/2017

    Distribution

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

    Quantity

    1243 kits