Medical device recalls Moderate risk

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Recall date
September 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0378-2026
FDA classification
Class II
Brand / firm
Fresenius Kabi USA, LLC
Sold / distributed
US Nationwide distribution in the state of Minnesota.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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