# FDA recall Z-1282-2024

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2022-09-16.

## Product

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

## Reason for recall

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm.    This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

## Distribution

US Nationwide distribution in the states of WI and NJ.

## Key facts

- **Recall number:** Z-1282-2024
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-09-16
- **Report date:** 2024-03-20

- **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-1282-2024

## Citation

> AI Analytics. FDA recall Z-1282-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1282-2024. Source: US FDA. Licensed CC0.

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