FDA recall Z-0378-2026

Fresenius Kabi USA, LLC · Class II · device

Product

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

Reason for recall

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Distribution

US Nationwide distribution in the state of Minnesota.

Key facts

Status
Ongoing
Initiation date
2025-09-03
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0378-2026