Medtronic Perfusion Systems Recall: Affinity NT Oxygenator, Oxygenator with Balance Biosur
Medtronic Perfusion Systems Recall: Affinity NT Oxygenator, Oxygenator with Balance Biosur is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Perfusion Systems; Product: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product
| Recalling firm | Medtronic Perfusion Systems |
|---|---|
| Product | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B |
| Reason for recall | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US States: AZ, CA, TN |
| Recall initiated | 20250912 |
| Recall number | Z-0487-2026 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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