Recall Z-0234-2016 ยท OUB Instrument For Treatment Of Hyperhidrosis
Miramar Labs, Inc.
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.
| Date | Nov 6, 2015 (initiated Oct 9, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 1-855-647-2 |
| Quantity | 277 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |