BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0234-2016 · Initiated October 9, 2015

    Recall

    Recall Number
    Z-0234-2016
    Event Number
    72386
    Firm
    Miramar Labs, Inc.
    FEI Number
    3008082710
    Product Code
    OUB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 9, 2015
    Posted
    November 6, 2015
    Terminated
    December 23, 2015
    Address
    2790 Walsh Ave, Santa Clara, CA, 95051-0963

    Description

    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.

    Reason

    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

    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 [email protected]

    Distribution

    Nationwide Distribution

    Quantity

    277 units