FDA recall Z-1048-2026

Fresenius Kabi USA, LLC · Class II · device

Product

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Reason for recall

Emphasizing instructions for LVP duration programming located in the IFU.

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.

Key facts

Status
Ongoing
Initiation date
2025-11-21
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2026