Device product
Thoraguard Chest Tube Kit, 20 Fr
Z-0105-2022
Product summary
- Firm
- Centese Inc.
- Event
- Event 88616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310 kits
- Official record key
device-enforcement:Z-0105-2022
Official wording
Reason: An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
Code information: Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102
Distribution pattern: Distribution to a single consignee located in California.
Derived failure modes
-
Unknown
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.