FDA-Device2024-03-27Class II
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Mc3 Inc
Hazard
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
Sold states
US Nationwide distribution.
Affected count
299 units
Manufactured in
2555 Bishop Cir W, Dexter, MI, United States
Products
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1309-2024Don't want to check this manually?
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