Z-0234-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- October 9, 2015
- Termination Date
- December 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 277 units
Product 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 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.
Distribution Pattern
Nationwide Distribution
Code Information
MN-MD4000-MC, all units