BEUDAMED
    FDA Recall 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 · Initiated July 15, 2020

    Recall

    Recall Number
    Z-3002-2020
    Event Number
    86312
    Firm
    OraSure Technologies, Inc.
    FEI Number
    3004142665
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 15, 2020
    Terminated
    March 14, 2022
    Address
    220 E 1st St, Bethlehem, PA, 18015-1360

    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

    Action

    Orasure notified Distributors via email on 6/26/20 of the action to take re: the unsealed boxes. Rework to be performed by foreign Distributors and US product to be returned to the manufacturer for rework or scrap.

    Distribution

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

    Quantity

    3000 units