BEUDAMED
    FDA Enforcement Class II Terminated

    Basic Face Kit, part number PS517A(D

    Recall: Z-1265-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1265-2017
    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

    Basic Face Kit, part number PS517A(D

    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 81973, 5/29/2018 82332, 5/13/2018 84698, 2/10/2018 84985, 8/6/2018 85899, 8/26/2018 86370, 8/1/2018 86729, 12/26/2018 89108, 11/15/2018 89302, 12/25/2018 89652, 11/19/2018 94627, 1/11/2019 95899, 5/21/2019 96504, 5/5/2019 97666, 6/26/2019 97832, 6/13/2019 99264, 9/3/2019

    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

    965 kits