# FDA recall Z-1048-2026

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2025-11-21.

## Product

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

## Reason for recall

Emphasizing instructions for LVP duration programming located in the IFU.

## Distribution

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

## Key facts

- **Recall number:** Z-1048-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-21
- **Report date:** 2026-01-21

- **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-1048-2026

## Citation

> AI Analytics. FDA recall Z-1048-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1048-2026. Source: US FDA. Licensed CC0.

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