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Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Medical DevicesSource: FDA (device) · Date: 2025-12-24

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Kabi USA, LLC
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason / hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Classification
Class I
Status
Ongoing
Distribution / sold at
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Recall initiated
2025-11-14
Code info
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Product quantity
30 units
Voluntary mandated
Voluntary: Firm initiated
City
North Andover
State
MA
Country
United States
Event id
98009
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