Recall Z-1275-2012 ยท GEH Unit, Cryosurgical, Accessories
Healthtronics, Inc.
CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
| Date | Mar 21, 2012 (initiated Feb 27, 2012) |
| Status | Terminated |
| Reason | HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance. |
| Root cause | Labeling mix-ups |
| Action | Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification |
| Quantity | 9274 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101333 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc., Jun 14, 2010 |