Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
From the FDA notice · Read the official notice ↗ · All Medtronic recalls
What to do
The agency's notice has the remedy and who to contact.
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Compare your label or packaging with the recalled product.
- Product
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- Sold in
- US States: AZ, CA, TN
- Made for
- All ages (under 100 years)
Details
- Units affected
- 26 units
- Illnesses reported
- None reported
- Manufactured in
- 7611 Northland Dr N, Brooklyn Park, MN, United States
- Classification
- Class II
- Recall number
- Z-0487-2026
In the FDA's words
- Description
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846 Distribution: US States: AZ, CA, TN Affected quantity: 26 units
- Hazard
- Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.