Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Published June 10, 2026 · Recall initiated: May 6, 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
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Lot
- Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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