FDA recall Z-0105-2022
Centese Inc. · Class II · device
Product
Thoraguard Chest Tube Kit, 20 Fr
Reason for recall
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
Distribution
Distribution to a single consignee located in California.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-31
- Report date
- 2021-10-20
- Termination date
- 2023-08-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Omaha, NE, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2022