Recall Z-0885-2026— Fresenius Kabi USA, LLC

Name: FDA recall Z-0885-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-14

Class I · Ongoing

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-11-14. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.. Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Ongoing
Initiated: 2025-11-14
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 (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Reason for recall

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

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