Fresenius Kabi USA, LLC: Device Recall

Recall #Z-0378-2026 · 09/03/2025

Class II: Risk

Recall Details

Recall Number: Z-0378-2026
Classification: Class II
Product Type: Device
Recalling Firm: Fresenius Kabi USA, LLC
Status: Ongoing
Date Initiated: 09/03/2025
Location: North Andover, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

Reason for Recall

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

Product Description

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Distribution Pattern

US Nationwide distribution in the state of Minnesota.

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 I: Dangerous 11/03/2025

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

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.