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Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).
Recalled December 10, 2025 · FDA recall Z-0586-2026 · Fresenius Kabi USA
Hazard
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. · FDA Class I
Units
483 cases (12,075 eaches)
Sold at
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Description
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →