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U.S. Department of Health and Human Services

Class 2 Device Recall HealthTronics Endocare 3.8mm RenalCryo Cryoprobe

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  Class 2 Device Recall HealthTronics Endocare 3.8mm RenalCryo Cryoprobe see related information
Date Initiated by Firm December 20, 2012
Date Posted February 15, 2013
Recall Status1 Terminated 3 on April 22, 2013
Recall Number Z-0825-2013
Recall Event ID 63933
510(K)Number K101333  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
Code Information Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L
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		 The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355.
Quantity in Commerce 50 units
Distribution Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
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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