Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 09, 2015
Date PostedNovember 06, 2015
Recall Status1 Terminated 3 on December 23, 2015
Recall NumberZ-0234-2016
Recall Event ID 72386
510(K)NumberK103014 K131162 K150419 
Product Classification Instrument for treatment of hyperhidrosis - Product Code OUB
ProductmiraDry 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
For Additional Information ContactKathy 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
ActionMiramar 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 Commerce277 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = OUB
-
-