BEUDAMED
    FDA Enforcement Class II Terminated

    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0145-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0145-2017
    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

    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. 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: 57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 59975 7/18/2015 60444 9/13/2015 60705 8/3/2015 61043 8/20/2015 61552 11/27/2015 62834 11/7/2015 63155 11/27/2015 63156 1/2/2016 64068 11/23/2015 64504 11/10/2015 65556 11/9/2015 65855 11/6/2015 66687 11/26/2015 67232 11/18/2015 67233 8/10/2016 67579 8/22/2016 68618 7/11/2016 68940 9/12/2016 69988 9/23/2016 71297 9/12/2016 71430 12/25/2016 71814 12/13/2016 72034 3/13/2017 73741 4/3/2017 74154 4/26/2017 74893 5/4/2017 75440 5/14/2017 75692 7/12/2017 76228 7/3/2017 76544 7/29/2017 76710 8/29/2017 77124 9/23/2017 79188 9/16/2017 79450 1/9/2018 79755 2/28/2018

    Distribution

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

    Quantity

    2266 kits