FDA recall Z-1869-2025

Fresenius Kabi USA, LLC · Class I · device

Product

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

Reason for recall

Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

Distribution

US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.

Key facts

Status: Ongoing
Initiation date: 2025-05-12
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1869-2025