---
title: "Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont... — FDA record Z-0885-2026 | Is It on Recall"
description: "Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death."
url: https://isitonrecall.com/recall/fda-device-z-0885-2026-ivenix-infusion-system-iis-lvp-software-lvp-sw-0005-software-for-the-controlled-administration-of-fl/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patie... — FDA record Z-0885-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- **Reason**: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- **Classification**: Class I
- **Recalling firm**: Fresenius Kabi USA, LLC
- **Quantity**: 30 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0885-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0885-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Software Versions 5.10.1 and prior; UDI: 00811505030122. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Dec 24, 2025
- **Recall initiation date**: Nov 14, 2025
- **Center classification date**: Dec 16, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0885-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fresenius Kabi USA, LLC records](https://isitonrecall.com/brand/fresenius-kabi-usa-llc/)