Fresenius Kabi USA, LLC: Device Recall

Recall #Z-0586-2026 · 11/03/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0586-2026
Classification: Class I
Product Type: Device
Recalling Firm: Fresenius Kabi USA, LLC
Status: Ongoing
Date Initiated: 11/03/2025
Location: North Andover, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 483 cases (12,075 eaches)

Reason for Recall

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

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.

Distribution Pattern

US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.

Other Recalls by Fresenius Kabi USA, LLC

Class II: Risk 11/21/2025

Emphasizing instructions for LVP duration programming located in the IFU.
Class I: Dangerous 11/14/2025

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class I: Dangerous 11/06/2025

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II: Risk 11/03/2025

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class II: Risk 09/03/2025

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

View all recalls by Fresenius Kabi USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.