FDA recall Z-0848-2026

Fresenius Kabi USA, LLC · Class II · device

Product

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Reason for recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-11-03
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0848-2026