Recall Z-1048-2026— Fresenius Kabi USA, LLC

Name: FDA recall Z-1048-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-21

Class II · Ongoing

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-11-21. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.. Reason: Emphasizing instructions for LVP duration programming located in the IFU..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-11-21
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.

Reason for recall

Emphasizing instructions for LVP duration programming located in the IFU.

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