BEUDAMED
    FDA Enforcement Class II Terminated

    DermaPro Waterproof Silicone Tape, SNS57232

    Recall: Z-2229-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2229-2018
    Event ID
    80234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Safe N Simple, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 20, 2018
    Initiation Date
    December 14, 2017
    Classification Date
    June 14, 2018
    Termination Date
    April 4, 2019
    Address
    5827 Terex, N/A, Clarkston, MI, 48346-1717, United States

    Description

    DermaPro Waterproof Silicone Tape, SNS57232

    Reason

    The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.

    Code Info

    20170716.

    Distribution

    Distributors in two states: AL and OH.

    Quantity

    318 rolls