Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
- Recalling company
- Fresenius Kabi USA, LLC
- 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.
- Reason
- Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Nov 3, 2025
- Reported
- Dec 10, 2025
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Status
- Ongoing
- Quantity
- 483 cases (12,075 eaches)
- Lot / codes
- Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
- Company location
- North Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0586-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0586-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.