BEUDAMED
    FDA Recall Terminated

    Minor Procedure Pack, part number AMS4799

    Recall: Z-1342-2017 · Initiated January 11, 2017

    Recall

    Recall Number
    Z-1342-2017
    Event Number
    76280
    Firm
    Windstone Medical Packaging, Inc.
    FEI Number
    1000125955
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 11, 2017
    Posted
    February 28, 2017
    Terminated
    May 3, 2017
    Address
    1602 4th Ave N, Billings, MT, 59101-1521

    Description

    Minor Procedure Pack, part number AMS4799

    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.

    Action

    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to [email protected].

    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

    365 kits