Home / Recalls / Derma Pen, LLC / Z-2740-2015

Z-2740-2015 Class II Terminated

Recalled by Derma Pen, LLC — Salt Lake City, UT

Recall Details

Product Type: Devices
Report Date: September 16, 2015
Initiation Date: February 5, 2015
Termination Date: January 31, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,466 units

Product 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 for Recall

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

Distribution Pattern

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.

Code Information

All devices on the market