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Terumo Cardiovascular Systems Corporation recalls CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Recalled April 12, 2023 · FDA recall Z-1345-2023 · Terumo Cardiovascular Systems
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. · FDA Class II
Units
1412 units
Sold at
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Description
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.
Product
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →