Z-1019-2025Class I

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient...

Name: Z-1019-2025 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient...
Creator: Fresenius Kabi USA, LLC
Published: 2025-01-10
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-01-10 / Open, Classified / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration... on 2025-01-10. FDA classified it as Class I and gives the reason as "Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2...". 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-1019-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-10
Posted: 2025-02-04
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Product code: FRN Pump, Infusion
Reason for recall: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Root cause tag: software
FDA root cause: Software Design Change
Action: Fresenius Kabi began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.
Quantity in commerce: 23 systems
Distribution: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
Product codes and lots: UDI-DI: 00811505030122. Software 5.9.2 and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

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)