Medical device recalls High risk

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

Recall date
December 6, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0763-2025
FDA classification
Class I
Brand / firm
Fresenius Kabi USA, LLC
Sold / distributed
US distribution to states of: ID, MN, NV, TX, VA, WI.

Why it was recalled

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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