Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
LVP Software of the Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Software has anomalies that have the potential to...
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
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Quantity: 17 units
Why Was This Recalled?
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Where Was This Sold?
This product was distributed to 13 states: CA, CO, ID, MI, NE, NV, NJ, OK, TX, UT, VA, WA, 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