Z-0586-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2025
- Initiation Date
- November 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 483 cases (12,075 eaches)
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Code Information
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.