FDA DeviceClass IINotable

FDA Recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Date: 2026-06-10
Brand: Fresenius Kabi USA, LLC
Category: Medical Device
FDA Class: Class II

Description

Potential for the Cassette Loading Lever to break.

Hazard

Potential for the Cassette Loading Lever to break.

Remedy

18,444 installed bases

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