Class I — UrgentReported 2025-12-10

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 for Recall

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Recall Number

Z-0586-2026

Classification

Class I

Status

Ongoing