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Fresenius Kabi recall of Ivenix infusion systems in Class I

April 19, 2023 By Danielle Kirsh

Fresenius Kabi logo updatedThe FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind.

Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.

The leak could damage the electrical system and result in a loss of power and failure of the system’s set identification sensor, which can delay or interrupt treatments. This issue may cause serious injury or death to patients due to interruption, under-infusion or delays in the delivery of critical fluids, blood products and medication, according to an FDA notice.

Fresenius Kabi has received 14 complaints related to this issue. There have been no reported injuries or deaths.

Get the full story on our sister site, MassDevice.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Fresenius Kabi

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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