BEUDAMED
    FDA Enforcement Class II Terminated

    Set-Up Pack, part number PSS1305(C

    Recall: Z-1367-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1367-2017
    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

    Set-Up Pack, part number PSS1305(C

    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 100280, 9/22/2019 101104, 9/14/2019 84089, 6/29/2018 85293, 7/29/2018 85807, 8/21/2018 86209, 9/23/2018 86427, 8/9/2018 86627, 8/11/2019 87734, 9/29/2018 87934, 9/7/2018 87935, 11/21/2018 87936, 12/25/2018 87937, 12/29/2018 89476, 1/28/2019 95646, 1/10/2019 96062, 1/16/2019 96463, 3/8/2019 96464, 6/22/2019 96465, 5/28/2019 96466, 5/29/2019 96807, 6/6/2019 97610, 6/19/2019 97611, 6/17/2019 97878, 9/25/2019 97878, 9/25/2019 99195, 9/14/2019

    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

    1275 kits