Recall Z-0105-2022 ยท GBX Catheter, Irrigation
Centese Inc.
Thoraguard Chest Tube Kit, 20 Fr
| Date | Aug 31, 2021 |
| Status | Terminated |
| Reason | An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. |
| Root cause | Under Investigation by firm |
| Action | The impacted consignee was notified via email of the recall on 08/31/2021. The customer has been instructed to immediately cease product use and return all impacted product to the recalling firm. |
| Quantity | 310 kits |
| Distribution | Distribution to a single consignee located in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.