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.
This recall has been terminated (originally issued June 5, 2018).
- Company
- Pentax Of America Inc
- Recall Initiated
- March 30, 2018
- Posted
- June 5, 2018
- Terminated
- April 28, 2021
- Recall Number
- Z-2256-2018
- Quantity
- 57 units
- Firm Location
- Redwood City, CA
- Official Source
- View on FDA website ↗
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 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.
Distribution
Distribution US nationwide.
Lot / Code Info
Lot Codes: 02132018-01 & 02162018-03
Root Cause
Vendor change control
Action Taken
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 in the package is a Federal Express shipping label for the returned merchandise. Customers with questions can call 650-318-5899, Monday through Friday 8:30 AM - 5 PM, PST.