FDA-Device2025-11-19Class II
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic Perfusion Systems
Hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Sold states
US States: AZ, CA, TN
Affected count
26 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2026Don't want to check this manually?
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