Device recall
Z-0079-2007: CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath…
FDA device recall · Class III · ATS Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0079-2007 |
|---|---|
| Recall event | 35745 |
| Product | CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console. |
| Product code | GEH |
| Recalling firm | ATS Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 2, 2006 |
| 510(k) numbers | K053436 |
| FEI number | 3008592544 |
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