Z-0848-2026Class II

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

Name: Z-0848-2026 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004
Creator: Fresenius Kabi USA, LLC
Published: 2025-11-03
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-11-03 / Open, Classified / root cause: labeling and UDI

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004 on 2025-11-03. FDA classified it as Class II and gives the reason as "Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0848-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-03
Posted: 2025-12-01
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Product code: FRN Pump, Infusion
Reason for recall: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Fresenius Kabi notified consignees on about 11/03/2025 via emailed letter. Consignees were informed of the issue and instructed to account for additional backpressure if check valve is used when configuring the downstream occlusion pressure alarm setting, adjust the occlusion alarm pressure to allow for a more balanced approach between occlusion detection and avoidance of unnecessary alarms, and continue to follow all Instructions for Use and institutional policies regarding infusion pump setup, monitoring, and alarm response. Consignees were requested to ensure all relevant persons within the organization are informed about this letter and the actions as described per the enclosed Tip Sheet on How to Use a Check Valve with the Ivenix Pump & Administration Sets. Additionally, consignees were requested complete and return the Customer Reply Form. Fresenius Kabi plans to update the Instructions for Use to include the information presented in the "Required Actions for Users", "Important Note on Check Valve Usage" and/or Tip Sheet on "How to Use a Check Valve with the Ivenix Pump & Administration Sets" for which scheduling is still being finalized.
Quantity in commerce: 15,862 units
Distribution: US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, 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-0848-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-01

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)