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Z-0586-2026Class I

Fresenius Kabi USA, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Fresenius Kabi USA, LLC
Product type
Device
Status
Ongoing
Report date
2025-12-10
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Firm state
MA
Product quantity
483 cases (12,075 eaches)
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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.

Code / lot info

Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →