Z-2274-2026Class II

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

Name: Z-2274-2026 The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004
Creator: Fresenius Kabi USA, LLC
Published: 2026-02-04
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2026-02-04 / Open, Classified / root cause: design

FDA source

Fresenius Kabi USA, LLC began a recall of The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004 on 2026-02-04. FDA classified it as Class II and gives the reason as "Potential for the Cassette Loading Lever to break". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2274-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-04
Posted: 2026-05-29
Recalling firm: Fresenius Kabi USA, LLC
Product: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Product code: FRN Pump, Infusion
Reason for recall: Potential for the Cassette Loading Lever to break.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 18,444 installed bases
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Product codes and lots: Model Number: LVP-0004. UDI-DI: 00811505030320

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2274-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2274-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code FRN

K183311Class IIIvenix Infusion System (IIS)Ivenix, Inc. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)