FDA recall Z-0885-2026

Fresenius Kabi USA, LLC · Class I · device

Product

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Reason for recall

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Distribution

US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

Key facts

Status
Ongoing
Initiation date
2025-11-14
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2026