Z-0825-2013 Class II Terminated

Recalled by Healthtronics, Inc. — Austin, TX

Recall Details

Product Type
Devices
Report Date
February 27, 2013
Initiation Date
December 20, 2012
Termination Date
April 22, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 units

Product Description

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.

Reason for Recall

The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

Distribution Pattern

Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI

Code Information

Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L