Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Downstream Occlusion alarms may occur during procedures using...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.
Affected Products
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Quantity: 15,862 units
Why Was This Recalled?
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report