Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)…

Recall date

November 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0586-2026

FDA classification

Class I

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.