BEUDAMED
    FDA Enforcement Class II Terminated

    Bayview Breast Pack, part number 009080-2

    Recall: Z-1274-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1274-2017
    Event ID
    76280
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 8, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    February 28, 2017
    Termination Date
    May 3, 2017
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Bayview Breast Pack, part number 009080-2

    Reason

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot number and expiration date 84687, 2/24/2018 86231, 2/9/2018 89386, 4/8/2018 94891, 4/23/2018 95261, 4/12/2018 95968, 4/1/2018 96742, 4/23/2018

    Distribution

    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

    Quantity

    126 kits