Recall Z-2256-2018 ยท GEH Unit, Cryosurgical, Accessories
PENTAX of America Inc
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.
| Date | Jun 5, 2018 (initiated Mar 30, 2018) |
| Status | Terminated |
| Reason | 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 controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller. |
| Root cause | Vendor change control |
| Action | On 3/30/2018, C2 Therapeutics issued URGENT FIELD CORRECTION notices to customers via certified mail, return receipt requested. Customers are advised to take the following Action: - Forward a copy of the notice and the enclosures to the department in which is referenced in the notice. - Inspect stock and quarantine products identified within the notice. - The end user of the affected products should complete and return the response form via email to RMA@c2therapeutics.com. The response form contains an RMA number to allow for the return of devices affected by this field action, and enclosed |
| Quantity | 57 units |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM C2 Therapeutics, Aug 22, 2013 |