FDAFDA · Food and drugs·Recall number Z-2274-2026
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Published June 10, 2026 · Recall initiated: February 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the Cassette Loading Lever to break.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- 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.
- Lot
- Model Number: LVP-0004. UDI-DI: 00811505030320
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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