# FDA recall Z-1313-2023

> **Fresenius Kabi USA, LLC** · Class I · device recall initiated 2023-03-10.

## Product

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

## Reason for recall

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

## Distribution

Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.

## Key facts

- **Recall number:** Z-1313-2023
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-04-19

- **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-1313-2023

## Citation

> AI Analytics. FDA recall Z-1313-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1313-2023. Source: US FDA. Licensed CC0.

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