| Class 2 Device Recall DermaPen | |
Date Initiated by Firm | February 05, 2015 |
Date Posted | September 05, 2015 |
Recall Status1 |
Terminated 3 on January 31, 2017 |
Recall Number | Z-2740-2015 |
Recall Event ID |
71149 |
Product Classification |
Microneedle Roller/Stamp - Product Code PIU
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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. |
Code Information |
All devices on the market |
Recalling Firm/ Manufacturer |
Derma Pen, LLC 3216 Highland Dr Suite 200 Salt Lake City UT 84106-4178
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For Additional Information Contact | Chad A. Milton 800-981-5402 Ext. 101 |
Manufacturer 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. |
FDA Determined Cause 2 | No Marketing Application |
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. |
Quantity in Commerce | 1,466 units |
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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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