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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe		see related information
Date Posted February 15, 2013
Recall Number Z-0825-2013
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, Texas 78717-4929
For Additional Information Contact Scott Eden
512-439-8355
Reason for
Recall		 The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect 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
 
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