Device recall
Z-2256-2018: C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is…
FDA device recall · Class II · PENTAX of America Inc
Key facts
| Recall number (Z-number) | Z-2256-2018 |
|---|---|
| Recall event | 80180 |
| Product | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. |
| Product code | GEH |
| Recalling firm | PENTAX of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K131523 |
| FEI number | 3008780134 |
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