Drug recall
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in…
FDA recall event 80180 · Class II · PENTAX of America Inc
Key facts
| Event ID | 80180 |
|---|---|
| Recall numbers | Z-2256-2018 |
| Recalling firm | PENTAX of America Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the… |
| Initiation date | Mar 30, 2018 |
| Report date | Jun 27, 2018 |
| Termination date | Apr 28, 2021 |
| City | Redwood City |
| State | CA |
| Country | United States |
| FEI number | 3008780134 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: