Medtronic Perfusion Systems
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →