BEUDAMED
    FDA Enforcement Class II Terminated

    Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0249-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0249-2017
    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

    Newport Coast Basic Pack, Kit number 007484-1 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: 59310 7/9/2015 63339 11/11/2015 61486 11/27/2015 65400 11/30/2015 65399 12/26/2015 67044 4/5/2016 67905 5/13/2016 75637 6/25/2016 74959 8/5/2016 71107 8/11/2016 71635 8/29/2016 74764 1/15/2017 78706 9/26/2017

    Distribution

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

    Quantity

    280 kits