# FDA recall Z-0586-2026

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

## Product

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

## Reason for recall

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

## Distribution

US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.

## Key facts

- **Recall number:** Z-0586-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **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-0586-2026

## Citation

> AI Analytics. FDA recall Z-0586-2026. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0586-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*