# FDA recall Z-0848-2026

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2025-11-03.

## Product

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

## Reason for recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

## Distribution

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

## Key facts

- **Recall number:** Z-0848-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-03
- **Report date:** 2025-12-10

- **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-0848-2026

## Citation

> AI Analytics. FDA recall Z-0848-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0848-2026. Source: US FDA. Licensed CC0.

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