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

FDA device recall Z-0848-2026 · posted 2025-12-01 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

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

Action taken

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.

Root cause

Labeling design

Status

Open, Classified

Product code

FRN

Quantity affected

15,862 units

Distribution

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

Date initiated

2025-11-03

Date posted

2025-12-01

Location

North Andover, MA

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