BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0166-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0166-2017
    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

    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L 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: 62733 11/3/2015 62734 11/11/2015 63822 11/15/2015 63851 1/1/2016 64256 1/3/2016 64255 1/13/2016 63852 4/2/2016 69318 7/14/2016 69233 7/18/2016 69910 9/17/2016 70959 12/6/2016 70958 1/3/2017 73965 1/9/2017 73697 1/20/2017 73698 1/23/2017 75426 5/18/2017 73966 5/20/2017 76637 6/11/2017 76070 6/30/2017 78670 8/13/2017 78276 9/30/2017

    Distribution

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

    Quantity

    1470 kits