BEUDAMED
    FDA Recall Terminated

    9x15" Medium Utility Positioner with Cover

    Recall: Z-0417-2018 · Initiated July 26, 2017

    Recall

    Recall Number
    Z-0417-2018
    Event Number
    78058
    Firm
    Molnlycke Health Care, Inc
    FEI Number
    1629080
    Product Code
    OUW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 26, 2017
    Terminated
    April 6, 2021
    Address
    5550 Peachtree Pkwy, Ste 500, Norcross, GA, 30092-2555

    Description

    9x15" Medium Utility Positioner with Cover

    Reason

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

    Action

    Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.

    Distribution

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

    Quantity

    204 units total