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Recall Observatory FDA recall evidence

Device 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.

Z-0586-2026

November 03, 2025

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 97941
Status
Ongoing
Classification
Class I
Quantity
483 cases (12,075 eaches)
Official record key
device-enforcement:Z-0586-2026

Official wording

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

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

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Incorrect assembly