BEUDAMED
    FDA Enforcement Class II Terminated

    7x10" Small Utility Positioner with Cover

    Recall: Z-0416-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0416-2018
    Event ID
    78058
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Molnlycke Health Care, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    July 26, 2017
    Classification Date
    January 26, 2018
    Termination Date
    April 6, 2021
    Address
    5550 Peachtree Pkwy Ste 500, Norcross, GA, 30092-2555, United States

    Description

    7x10" Small Utility Positioner with Cover

    Reason

    Products may not meet specifications due to possible presence of metal shavings.

    Code Info

    Recorder Code 1400227

    Distribution

    Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

    Quantity

    960 units total