Recall Z-2740-2015— Derma Pen, LLC
Class II · Terminated
Class II FDA medical device recall by Derma Pen, LLC, initiated 2015-02-05, terminated 2017-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Derma Pen, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-05
- Terminated
- 2017-01-31
- Firm location
- Salt Lake City, UT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.