Recall Z-0586-2026— Fresenius Kabi USA, LLC

Name: FDA recall Z-0586-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-03

Class I · Ongoing

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-11-03. It names one FDA 510(k) clearance: K183311. 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: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-11-03
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 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.

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