Recall Z-1869-2025— Fresenius Kabi USA, LLC

Name: FDA recall Z-1869-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Class I · Ongoing

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-05-12. It names one FDA 510(k) clearance: K183311. Product: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.. Reason: 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..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-05-12
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.