Fresenius Kabi Usa, Llc: Lvp Software Of The Ivenix Infusion System (iis); Product Code Lvp-sw-0005
Recall Summary Fresenius Kabi is recalling the LVP software (Product Code LVP-SW-0005) used in the Ivenix Infusion System pump due to a software problem that can cause the pump to display an incorrect battery level and shut down unexpectedly, requiring it to be plugged into AC power to restart. This recall affects infusion pumps distributed nationwide across multiple states. The company classified this as a Class I recall, the most serious category.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/711e2332-ab17-4f49-bce8-de7e0c83b0b3