FDA-Device2025-12-10Class IPROCESSING DEFECT
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.
Hazard
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Affected count
483 cases (12,075 eaches)
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0586-2026More Fresenius Kabi recalls
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