Recall Z-1326-2019 ยท GEH Unit, Cryosurgical, Accessories
PENTAX of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller,
| Date | Dec 3, 2018 |
| Status | Terminated |
| Reason | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. |
| Root cause | Under Investigation by firm |
| Action | Letters dated 12/3/2018 were issued via USPS mailing on 12/3/2018 explaining the issue and instructing the customer to discontinue use of the device and to ensure all potential users in the customer facility are aware of the recall notification and recommended actions. For questions regarding this action, please contact PENTAX Medical Customer Service. Tel: 650-318-5899 (8:30 AM 5:00 PM, Monday Friday, PST) Fax: 650-318-5899 Email: RMA@C2Therapeutics.com |
| Quantity | 68 devices |
| Distribution | Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163684 | C2 CryoBalloon Ablation System C2 Therapeutics, Inc., Jan 23, 2018 |