BEUDAMED
    FDA Recall Terminated

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    Recall: Z-2740-2015 · Initiated February 5, 2015

    Recall

    Recall Number
    Z-2740-2015
    Event Number
    71149
    Firm
    Derma Pen, LLC
    FEI Number
    3009081613
    Product Code
    PIU
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 5, 2015
    Posted
    September 5, 2015
    Terminated
    January 31, 2017
    Address
    3216 Highland Dr, Suite 200, Salt Lake City, UT, 84106-4178

    Description

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    Reason

    Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.

    Action

    Derma Pen sent a notification letter to its customers on February 5, 2015. The purpose of the notification was to inform customers that the FDA issued a warning letter and the steps Derma Pen was taking to address the FDA' s concerns. For further questions please call (800) 981-5402.

    Distribution

    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.

    Quantity

    1,466 units