Class 2 Device Recall CRYO Care Surgical System

• Date Initiated by Firm: February 27, 2012
• Date Posted: March 21, 2012
• Recall Status: Terminated on March 19, 2013
• Recall Number: Z-1275-2012
• Recall Event ID: 57924
• 510(K)Number: K101333
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
• Code Information: Multiple codes.
• FEI Number: 3008262715
• Recalling Firm/ Manufacturer: Healthtronics, Inc.; 9825 Spectrum Dr Bldg 2 # 275; Austin TX 78717-4929
• For Additional Information Contact: Scott Eden; 512-439-8355
• Manufacturer Reason for Recall: HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.
• FDA Determined Cause: Labeling mix-ups
• Action: Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification Section on page two, and 3) Return this letter with the affected product to the address provided. For questions about this recall contact Endocare, Inc at 877-367-4873.
• Quantity in Commerce: 9274 units
• Distribution: Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.
• 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.

• 510(K) Database: 510(K)s with Product Code = GEH