Z-0825-2013 Class II Terminated
FDA device recall Z-0825-2013 was initiated by Healthtronics, Inc. on December 20, 2012 and is designated Class II. Reason for recall: The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. The recall status is terminated (terminated April 22, 2013). Affected quantity: 50 units.
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