United StatesAffinity NT Oxygenator (Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir), Product Number 541B, Lot 231621003, Unit serial 5117755016, UDI‑DI 00763000187842 / 20763000187846, sold in AZ, CA and TN (26 units). Medtronic Perfusion Systems recalled the unit because it showed decreased CO2 gas transfer rates and did not meet performance requirements.
What's being recalled
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN, United States.
How to identify it
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
The hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US States: AZ, CA, TN
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)