BEUDAMED
    FDA Enforcement Class III Terminated

    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    Recall: Z-3002-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-3002-2020
    Event ID
    86312
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 30, 2020
    Initiation Date
    July 15, 2020
    Classification Date
    September 23, 2020
    Termination Date
    March 14, 2022
    Address
    220 E 1st St, N/A, Bethlehem, PA, 18015-1360, United States

    Description

    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    Reason

    Unit boxes not properly sealed

    Code Info

    Lot Numbers: 9214

    Distribution

    Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.

    Quantity

    3000 units