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Fresenius Kabi USA, LLC recalls LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Recalled April 17, 2024 · FDA recall Z-1484-2024 · Fresenius Kabi USA
Hazard
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. · FDA Class I
Units
17 units
Sold at
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Description
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Product
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →