Recall Z-0825-2013— Healthtronics, Inc.

Name: FDA recall Z-0825-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Class II · Terminated

Class II FDA medical device recall by Healthtronics, Inc., initiated 2012-12-20, terminated 2013-04-22. It names one FDA 510(k) clearance: K101333. 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.. Reason: 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.
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Terminated: 2013-04-22
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K101333 — CRYOCARE CS SURGICAL SYSTEMEndocare, Inc.·cleared 2010-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.