BEUDAMED
    FDA Enforcement Class II Terminated

    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0152-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0152-2017
    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 Breast Pack, Kit part numbers 009080-1 and 009080-2 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 NumbersExpiration Dates: 58626 10/25/2014 61076 5/14/2015 62460 6/4/2015 63884 6/6/2015 63742 6/11/2015 65028 6/12/2015 63220 6/18/2015 66436 11/27/2015 65659 11/30/2015 57175 5/16/2016 67267 5/17/2016 72357 5/25/2016 72480 7/21/2016 78609 1/17/2017

    Distribution

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

    Quantity

    312 kits