Drug recall
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA recall event 91775 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 91775 |
|---|---|
| Recall numbers | Z-1345-2023, Z-1346-2023, Z-1347-2023 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC, CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE, CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Mar 1, 2023 |
| Report date | Apr 12, 2023 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 3000204839 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: