Terumo Cardiovascular Systems Corporation: CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

Hazard

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.

Details from the source

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 thermistor is improperly bonded to the oxygenator port. Distribution: US Nationwide. Belgium, Canada, Costa Rica, Thailand. Quantity: 4940 units Lot/code info: UDI-DI: (01)00699753450868; Lot Number AM03

UPC codes

00699753450868

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.