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Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Medical DevicesSource: FDA (device) · Date: 2026-01-21

Read the official notice at FDA (device) →

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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.
Reason / hazard
Emphasizing instructions for LVP duration programming located in the IFU.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Recall initiated
2025-11-21
Code info
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Product quantity
30 units
Voluntary mandated
Voluntary: Firm initiated
City
North Andover
State
MA
Country
United States
Event id
98106
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