Recall Z-0105-2022— Centese Inc.
Class II · Terminated
Class II FDA medical device recall by Centese Inc., initiated 2021-08-31, terminated 2023-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Thoraguard Chest Tube Kit, 20 Fr. Reason: An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak..
- Recalling firm
- Centese Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-31
- Terminated
- 2023-08-07
- Firm location
- Omaha, NE, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.