FDAClass IIFebruary 27, 2013

HealthTronics Endocare 3.8mm RenalCryo Cryoprobe recall

HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical…

Why was HealthTronics Endocare 3.8mm RenalCryo Cryoprobe recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical…
Recalling firm
Healthtronics, Inc.
Quantity
50 units
Distribution
Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
Recall date
February 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls