Device recall
Z-1326-2019: Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX…
FDA device recall · Class II · PENTAX of America Inc
Key facts
| Recall number (Z-number) | Z-1326-2019 |
|---|---|
| Recall event | 82274 |
| Product | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus… |
| Product code | GEH |
| Recalling firm | PENTAX of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2020 |
| 510(k) numbers | K163684 |
| 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