Class I
Medical Device Recall: 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.
Fresenius Kabi USA, LLC · November 3, 2025
Reason for Recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
States Affected
NATIONWIDE
Quantity Affected
483 cases (12,075 eaches)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0586-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.