miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip an

FDA device recall Z-0234-2016 · posted 2015-11-06 · Terminated

Recall details

Recalling firm: Miramar Labs, Inc.
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.
Action taken: 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
Root cause: Labeling design
Status: Terminated
Product code: OUB
Quantity affected: 277 units
Distribution: Nationwide Distribution
Date initiated: 2015-10-09
Date posted: 2015-11-06
Date terminated: 2015-12-23
Location: Santa Clara, CA

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