Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0848-2026
• FDA 510(k) clearance · K183311The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Kabi USA, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.