FDA-Device2013-02-27Class II

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.

Healthtronics, Inc.
Hazard

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

Sold states
Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
Affected count
50 units
Manufactured in
9825 Spectrum Dr Bldg 2 # 275, N/A, Austin, TX, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2013

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