# FDA recall Z-1283-2024

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2023-05-10.

## Product

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

## Reason for recall

Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

## Distribution

US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

## Key facts

- **Recall number:** Z-1283-2024
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-05-10
- **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-1283-2024

## Citation

> AI Analytics. FDA recall Z-1283-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1283-2024. Source: US FDA. Licensed CC0.

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