Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Products Sold
(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW- due to Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characterist. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Recommended Action
Per FDA guidance
Ivenix initiated contact on 4/22/22/ via phone communicating the contents of the customer letter which was then emailed to each customer. Letter states reason for recall, health risk and action to take: Please note, the specified start-up flow accuracy of up to +8% is maintained throughout the extended start-up time; and the steady-state flow accuracy of +l-SYo of the LVP is not affected with this condition. There is no corrective action you need to take at this time. We believe that this condition is low risk in that the affected flow rate range is limited, the start'up flow rate accuracy is unaffected and still within specifications, and the clinical practice of monitoring patients while administering high alert drugs mitigates the risk. Ivenix is working on a software update to correct this condition. It will be available in approximately 60 days. We will inform you when that update is ready to install. If you have additional questions, please contact your Ivenix representative or support below. Customer support - email Customer support - phone suplrort@ivenix.com I-978-775-8TAA
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026