# FDA recall Z-0763-2025

> **Fresenius Kabi USA, LLC** · Class I · device recall initiated 2024-12-06.

## Product

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

## Reason for recall

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

## Distribution

US distribution to states of: ID, MN, NV, TX, VA, WI.

## Key facts

- **Recall number:** Z-0763-2025
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-06
- **Report date:** 2025-01-15

- **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-0763-2025

## Citation

> AI Analytics. FDA recall Z-0763-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0763-2025. Source: US FDA. Licensed CC0.

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