FDA Device recall Z-1345-2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 by Terumo Cardiovascular Systems, citing some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1345-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Reason
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Identifiers
| code_info | UDI-DI: (01)00699753450134; Lot Number: 2M10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Terumo Cardiovascular Systems
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FDA Device · Class II · 2025-07-02 · Terumo Cardiovascular Systems - Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Device · Class II · 2025-04-09 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
FDA Device · Class II · 2024-04-10 · Terumo Cardiovascular Systems - CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems
All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1345-2023%22
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