Medtronic Recalls Affinity Pixie Oxygenator for Possible Harmful Bacteria

Learn more about Medtronic's Recall of Affinity Pixie Oxygenation System

If your email program has trouble displaying this email, view as a webpage. Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of Endotoxins Medtronic is recalling the Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface due to potentially elevated levels of harmful bacteria called endotoxins. The use of a device with high endotoxin level may result in fever, infection, acute systemic toxic reaction, or death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? If you have questions about this recall, contact the Division of Industry and Consumer Education (DICE).

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