FDAHealthNovember 3, 2025
Fresenius Kabi USA, LLC — 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.
⚠️ Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 3, 2025
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
What's affected?
- 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.
- Lot code
- No
Additional details
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 483 cases (12,075 eaches).
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