Ivenix Infusion System (Fresenius Kabi) – downstream occlusion (2025)
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. Model Number: LVP-0004.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Model Number: LVP-0004. UDI-DI: 00811505030320.
Products Sold
Model Number: LVP-0004. UDI-DI: 00811505030320.
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. due to Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Recommended Action
Per FDA guidance
Fresenius Kabi notified consignees on about 11/03/2025 via emailed letter. Consignees were informed of the issue and instructed to account for additional backpressure if check valve is used when configuring the downstream occlusion pressure alarm setting, adjust the occlusion alarm pressure to allow for a more balanced approach between occlusion detection and avoidance of unnecessary alarms, and continue to follow all Instructions for Use and institutional policies regarding infusion pump setup, monitoring, and alarm response. Consignees were requested to ensure all relevant persons within the organization are informed about this letter and the actions as described per the enclosed Tip Sheet on How to Use a Check Valve with the Ivenix Pump & Administration Sets. Additionally, consignees were requested complete and return the Customer Reply Form. Fresenius Kabi plans to update the Instructions for Use to include the information presented in the "Required Actions for Users", "Important Note on Check Valve Usage" and/or Tip Sheet on "How to Use a Check Valve with the Ivenix Pump & Administration Sets" for which scheduling is still being finalized.
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