Class II — Centese Inc.
| Recalling firm | Centese, Inc. |
|---|---|
| Registered facility | CENTESE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak. |
| Product | Thoraguard Chest Tube Kit, 20 Fr |
| Quantity | 310 kits |
| Distribution | Distribution to a single consignee located in California. |
| Initiated | 2021-08-31 |
| Classified | 2021-10-13 |
| Terminated | 2023-08-07 |
| Recall number | Z-0105-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Centese Inc. (Z-0105-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88616/
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