HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory...
FDA Recall #Z-0825-2013 — Class II — December 20, 2012
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.
Recalling Firm
Healthtronics, Inc. — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
50 units
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated