Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Fluid ingress that can cause a loss of...
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 No. LVP-0004
Quantity: 1,546 units
Why Was This Recalled?
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Where Was This Sold?
This product was distributed to 5 states: CA, CO, NJ, UT, WI
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