BEUDAMED
    FDA Enforcement Class II Terminated

    Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0151-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0151-2017
    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

    Bayview Abdominoplasty Pack, Kit part number 009079-1 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: 57718 6/18/2016 60804 5/16/2015 62210 5/7/2015 62802 6/6/2015 66875 11/20/2015 72825 7/29/2016 73912 7/5/2016

    Distribution

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

    Quantity

    90 kits