# FDA recall Z-1019-2025

> **Fresenius Kabi USA, LLC** · Class I · device recall initiated 2025-01-10.

## 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.

## 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.

## Distribution

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.

## Key facts

- **Recall number:** Z-1019-2025
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-10
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2025

## Citation

> AI Analytics. FDA recall Z-1019-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1019-2025. Source: US FDA. Licensed CC0.

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