BEUDAMED
    FDA Enforcement Class II Terminated

    Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0180-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0180-2017
    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

    Endoscopy Pack, Kit number PSS1646 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: 59053 3/28/2015 77459 9/11/2015 65230 10/26/2015 60259 10/27/2015 61170 11/14/2015 66914 11/26/2015 64387 1/11/2016 63883 1/25/2016 57221 6/19/2016 57956 7/20/2016 77460 7/30/2016 69800 9/6/2016 70560 12/3/2016 72104 1/1/2017 72585 4/19/2017

    Distribution

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

    Quantity

    304 kits