Device 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.
Z-0825-2013
Product summary
- Event
- Event 63933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0825-2013
Official wording
Reason: The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
Code information: Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L
Distribution pattern: Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
Derived failure modes
-
Labeling or packaging
label on the outer box has the incorrect