BEUDAMED
    FDA Enforcement Class II Terminated

    Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0229-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0229-2017
    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

    Lumbar Laminectomy Pack, Kit number AMS2501 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: 64906 11/3/2015 66041 11/6/2015 62111 11/12/2015 65892 12/22/2015 66759 7/29/2016 69271 9/19/2016 68960 9/26/2016 67958 9/28/2016 70334 1/29/2017 74063 5/15/2017 75454 7/8/2017 80958 8/8/2017 78464 9/14/2017 77100 10/25/2017 79659 1/17/2018

    Distribution

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

    Quantity

    249 kits