BEUDAMED
    FDA Enforcement Class II Terminated

    Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

    Recall: Z-2330-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2330-2018
    Event ID
    80232
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Safe N Simple, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 4, 2018
    Initiation Date
    June 18, 2012
    Classification Date
    June 28, 2018
    Termination Date
    May 28, 2020
    Address
    5827 Terex, Clarkston, MI, 48346-1717, United States

    Description

    Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

    Reason

    The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.

    Code Info

    20120115.

    Distribution

    Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.

    Quantity

    17592