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 MIRA CR4055 Finger Probe

  • 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 Recall MIRA CR4055 Finger Probesee related information
Date Initiated by FirmApril 08, 2010
Date PostedJune 29, 2010
Recall Status1 Terminated 3 on August 08, 2016
Recall NumberZ-1919-2010
Recall Event ID 55818
Product Classification Cryophthalmic Unit - Product Code HPS
ProductMIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for the destruction of tumors.
Code Information SER# W04672-1 SER# 47-0505  SER# 48-0508  SER# 03-0506  One Unit no Serial Number
FEI Number 1218813
Recalling Firm/
Manufacturer		 Mira, Inc.
414 Quaker Hwy
Uxbridge MA 01569
For Additional Information ContactAaron P. Desjarlias
508-278-7877
Manufacturer Reason
for Recall		Devices distributed without an approved 510(k)
FDA Determined
Cause 2		PMA
ActionMira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.
Quantity in Commerce5 units
DistributionWorldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
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.
-
-