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The US Food and Drug Administration is warning health care providers to stop using a device from Medtronic PLC that’s used on pediatric patients.

The agency on 24 March designated a recall of the Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface as high-risk class I. Perfusion tubing packs used with the device were also recalled by Medtronic.

The Affinity Pixie is used on newborns, infants and small pediatric patients undergoing a cardiopulmonary bypass procedure. Medtronic recalled 126 of the devices because of “potentially elevated levels of harmful bacteria called endotoxins,” the FDA explained. “The use of a device with high endotoxin level may result in fever, infection, acute systemic toxic reaction or death.”

The recalled device was distributed between April and November 2020. No injuries or deaths have been reported.

Medtronic sent a recall notice to customers on 4 February that asked for the problematic devices to be quarantined and returned to the company.


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