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, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Firm state
MA
Product quantity
18,444 installed bases
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for the Cassette Loading Lever to break.
Product description
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Code / lot info
Model Number: LVP-0004. UDI-DI: 00811505030320
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.