FDA-Device2023-04-12Class II
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
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
4940 units
Manufactured in
125 Blue Ball Rd, Elkton, MD, United States
Products
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1347-2023Don't want to check this manually?
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