BEUDAMED
    FDA Enforcement Class II Terminated

    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0179-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0179-2017
    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

    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(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: 58460 7/10/2015 60260 7/18/2015 61708 10/14/2015 65115 11/17/2015 61937 11/29/2015 64687 1/12/2016 68445 3/17/2016 66915 7/5/2016 57957 7/21/2016 67620 9/29/2016 70297 10/26/2016 73096 11/12/2016 72508 11/21/2016 73565 12/20/2016 74851 1/23/2017 75802 4/30/2017 79176 5/5/2017 79475 5/26/2017 79793 6/27/2017

    Distribution

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

    Quantity

    666 kits