Date Initiated by Firm |
March 30, 2018 |
Date Posted |
June 05, 2018 |
Recall Status1 |
Terminated 3 on April 28, 2021 |
Recall Number |
Z-2256-2018 |
Recall Event ID |
80180 |
510(K)Number |
K131523
|
Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
|
Product |
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. |
Code Information |
Lot Codes: 02132018-01 & 02162018-03 |
Recalling Firm/ Manufacturer |
PENTAX of America Inc 303 Convention Way Ste 1 Redwood City CA 94063-1415
|
For Additional Information Contact |
Andy Wong 650-521-5304
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
57 units |
Distribution |
Distribution US nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEH and Original Applicant = C2 THERAPEUTICS
|