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

Potential for the Cassette Loading Lever to break.

Fresenius Kabi notified consignees on about 02/04/2026 via letter. Consignees were informed of the lever breakage and that two potential sources of the breakage were: 1. If the Cassette Loading Lever is left open during transport, it can be damaged if it is jarred by another object or surface. 2. Applying force to a locked Loading Lever when it is in the locked position can result in potential damage and/or cause it to break. Consignees were reminded of proper Loading Lever handling: 1. Do not force the Cassette Loading Lever open or closed. The lever does not require significant force to operate, and excessive force can damage the LVP. Excessive force can damage the LVP and prevent use. 2. The Cassette Loading Lever does not require excessive force to load or unload the administration set. 3. If the Cassette Loading Lever does not move with minimal force, do not continue to apply force. Check that the pump is not currently infusing and verify there are no obstructions. 4. When an infusion completes or is paused, the flow dial may take up to 5 seconds to close and unlock the Cassette Loading Lever. Consignees were also reminded of proper transport and storage to ensure the Cassette Loading Lever is fully closed prior to moving, transporting, or storing the pump, and after transport, visually confirm the Cassette Loading Lever is intact and moves freely before clinical use. Additionally, consignees were requested to complete and return the Customer Reply Form provided.