Device 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.
Z-0586-2026
Product summary
- Event
- Event 97941
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 483 cases (12,075 eaches)
- Official record key
device-enforcement:Z-0586-2026
Official wording
Reason: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Code information: Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Distribution pattern: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Derived failure modes
-
Manufacturing or process control
Incorrect assembly