BEUDAMED
    FDA Recall Terminated

    DermaPro Waterproof Silicone Tape, SNS57232

    Recall: Z-2229-2018 · Initiated December 14, 2017

    Recall

    Recall Number
    Z-2229-2018
    Event Number
    80234
    Firm
    Safe N Simple, LLC
    FEI Number
    3008374791
    Product Code
    KGX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 14, 2017
    Terminated
    April 4, 2019
    Address
    5827 Terex, Clarkston, MI, 48346-1717

    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.

    Action

    The recalling firm notified its distributors via phone call and email on January 3, 2018. The firm informed distributors of the issue with the affected product, and offered to replace affected product, and suggested replacing product distributed to customers.

    Distribution

    Distributors in two states: AL and OH.

    Quantity

    318 rolls