BEUDAMED
    FDA Enforcement Class II Terminated

    Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0161-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0161-2017
    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

    Cardiac Cath Pack, kit number AMS2707 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: 67078 11/16/2015 66903 11/26/2015 64343 12/24/2015 68965 9/10/2016 68647 9/18/2016 68147 9/28/2016 70233 10/30/2016 71064 12/7/2016

    Distribution

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

    Quantity

    138 kits