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Medtronic Perfusion Systems: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Medical DevicesSource: FDA (device) · Date: 2025-11-19

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Perfusion Systems
Product
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason / hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Classification
Class II
Status
Ongoing
Distribution / sold at
US States: AZ, CA, TN
Recall initiated
2025-09-12
Code info
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Product quantity
26 units
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn Park
State
MN
Country
United States
Event id
97702
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