# FDA recall Z-0002-2023

> **Fresenius Kabi USA, LLC** · Class I · device recall initiated 2022-09-08.

## Product

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004    version 5.2.0

## Reason for recall

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

## Distribution

Domestic distribution to NJ and WI.

## Key facts

- **Recall number:** Z-0002-2023
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-08
- **Report date:** 2022-10-12
- **Termination date:** 2024-09-10

- **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-0002-2023

## Citation

> AI Analytics. FDA recall Z-0002-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0002-2023. Source: US FDA. Licensed CC0.

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