Device recall
Z-1275-2012: CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral…
FDA device recall · Class II · Healthtronics, Inc.
Key facts
| Recall number (Z-number) | Z-1275-2012 |
|---|---|
| Recall event | 57924 |
| Product | 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. |
| Product code | GEH |
| Recalling firm | Healthtronics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 19, 2013 |
| 510(k) numbers | K101333 |
| FEI number | 3008262715 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database