Recall Z-1477-2017 ยท GEH Unit, Cryosurgical, Accessories
C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surger
| Date | Mar 15, 2017 (initiated Jan 6, 2017) |
| Status | Terminated |
| Reason | The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap. |
| Root cause | Under Investigation by firm |
| Action | Firm initially notified consignees who would be using the device in an upcoming procedure on January 6, 2017 to alert them of the potential issue and recommended that products with the affected cap not be used unless it can be checked by a C2 rep. Controller caps will be replaced within a few weeks; facilities will receive replacement caps by mail along with a shipping inventory label for return of those currently on hand. Formal recall letters were sent on January 19, 2017. Letters were sent by e-mail with receipt and read confirmation and follow up by phone call. |
| Quantity | 755 controller caps |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China. |
| FDA record | Open on fda.gov |