Recalling firm
Fresenius Kabi USA, LLC
Product type
Device
Status
Ongoing
Report date
2026-06-10
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.
Firm state
MA
Product quantity
32 systems
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data IntegrityReason for recall
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.
Product description
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Code / lot info
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Other recalls SPEQ maps to Data Integrity
See all Data Integrity recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.