Class 2 Device Recall MIRA CR4050 Finger Probe

• Date Initiated by Firm: April 08, 2010
• Date Posted: June 29, 2010
• Recall Status: Terminated on August 08, 2016
• Recall Number: Z-1918-2010
• Recall Event ID: 55818
• Product Classification: Cryophthalmic Unit - Product Code HPS
• Product: MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors.
• Code Information: SER# W04643-1 SER# 45-1109 SER# 44-1109 One Unit no Serial Number
• Recalling Firm/ Manufacturer: Mira, Inc.; 414 Quaker Hwy; Uxbridge MA 01569
• For Additional Information Contact: Aaron P. Desjarlias ; 508-278-7877
• Manufacturer Reason for Recall: Devices distributed without an approved 510(k)
• FDA Determined Cause: PMA
• Action: Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.
• Quantity in Commerce: 5 units
• Distribution: Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
• Total Product Life Cycle: TPLC 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.