Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy 

Fresenius Kabi USA, LLC, is correcting the Ivenix Infusion System Large Volume Pump (LVP) software, an infusion pump software due to multiple software anomalies and a cybersecurity vulnerability that have the potential to result in delay or underdosage of therapy.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.

Questions?

Customers in the U.S. with questions about this recall should contact Fresenius Kabi USA, LLC, at ivenix_support@fresenius-kabi.com or call 1-855-354-6387.