FDA-Device2023-04-12Class II
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Terumo Cardiovascular Systems Corporation
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.
Sold states
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Affected count
1412 units
Manufactured in
125 Blue Ball Rd, Elkton, MD, United States
Products
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1345-2023Don't want to check this manually?
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