This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. The affected products and recommendations for what to do with the devices below have not changed.
Affected Product
The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers recommending certain software versions of the Ivenix Infusion System be updated:
- Large Volume Pump (LVP) Software, version 5.9.2 and earlier
- Product code: LVP-SW-0005
- UDI: 00811505030122
- This software is part of the Ivenix Infusion System and is embedded in the Ivenix Large-Volume Pump, LVP-0004 (Pump UDI: 00811505030320)
What to Do
- On January 10, 2025, Fresenius Kabi USA began notifying affected customers recommending customers update the LVP software to version 5.10:
- Install the new Ivenix Infusion Management System (IMS) software version (5.2) on your…
