FDA recall Z-0586-2026

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.

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.

Key facts

Status

Ongoing

Initiation date

2025-11-03

Report date

2025-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0586-2026