Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
|---|---|
| Registered facility | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
| Product | Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW |
| Quantity | 52units |
| Distribution | MI Foreign: Japan, Belgium |
| Initiated | 2019-06-14 |
| Classified | 2019-07-30 |
| Terminated | 2020-06-11 |
| Recall number | Z-2102-2019 |
| 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 — Terumo Cardiovascular Systems Corporation (Z-2102-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83240/
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