BEUDAMED
    FDA Enforcement Class II Terminated

    General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0198-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0198-2017
    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

    General Surgery Pack, Kit number PSS1380(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: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 1/9/2018

    Distribution

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

    Quantity

    168 kits