Z-0885-2026Class I

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids...

Name: Z-0885-2026 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids...
Creator: Fresenius Kabi USA, LLC
Published: 2025-11-14
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-11-14 / Open, Classified / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients on 2025-11-14. FDA classified it as Class I and gives the reason as "Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0885-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-14
Posted: 2025-12-16
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Product code: FRN Pump, Infusion
Reason for recall: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to [email protected]. Customer questions can be directed to Customer Support via email at [email protected] or by phone at 1-855-354-6387.
Quantity in commerce: 30 units
Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Product codes and lots: Software Versions 5.10.1 and prior; UDI: 00811505030122.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0885-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-16

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)