Recall Z-0825-2013 ยท GEH Unit, Cryosurgical, Accessories
Healthtronics, Inc.
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.
| Date | Feb 15, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101333 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc., Jun 14, 2010 |