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 The device may experience mechanical interference on the...
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 LVP-0004
Quantity: 938 US
Why Was This Recalled?
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
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