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Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Medical DevicesSource: FDA (device) · Date: 2025-12-10

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), Large Volume Pump. Model Number: LVP-0004.
Reason / hazard
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
Recall initiated
2025-11-03
Code info
Model Number: LVP-0004. UDI-DI: 00811505030320.
Product quantity
15,862 units
Voluntary mandated
Voluntary: Firm initiated
City
North Andover
State
MA
Country
United States
Event id
97939
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