IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port...
FDA Recall #Z-0586-2026 — Class I — November 3, 2025
Product Description
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.
Recalling Firm
Fresenius Kabi USA, LLC — North Andover, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
483 cases (12,075 eaches)
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Code Information
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated