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U.S. Department of Health and Human Services

Class 2 Device Recall CRYO Care Surgical System

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  Class 2 Device Recall CRYO Care Surgical System see related information
Date Initiated by Firm February 27, 2012
Date Posted March 21, 2012
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = ENDOCARE, INC.
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