SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Check your package for
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- Why
- Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
- Distributed
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Company
- Fresenius Kabi USA, LLC
- Announced
- Recall began