Date Initiated by Firm | October 09, 2015 |
Date Posted | November 06, 2015 |
Recall Status1 |
Terminated 3 on December 23, 2015 |
Recall Number | Z-0234-2016 |
Recall Event ID |
72386 |
510(K)Number | K103014 K131162 K150419 |
Product Classification |
Instrument for treatment of hyperhidrosis - Product Code OUB
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Product | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories.
General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair. |
Code Information |
MN-MD4000-MC, all units |
Recalling Firm/ Manufacturer |
Miramar Labs, Inc. 2790 Walsh Ave Santa Clara CA 95051-0963
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For Additional Information Contact | Kathy O'Shaughnessy, PhD 408-579-8711 |
Manufacturer Reason for Recall | Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters. |
FDA Determined Cause 2 | Labeling design |
Action | Miramar Labs sent Medical Device Correction letters to all users on October 9, 2015 to inform them of the labeling clarification by UAPS First Class Certified mail or courier such as Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the firm added a new warning to their labeling. The firm included an updated copy of the MD4000-MC User Manual with the new warning included and asked that customers destroy their older copy. Customers with questions were instructed to call Customer SService at 1-855-647-2379 or email info@miraDry.com |
Quantity in Commerce | 277 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = OUB
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