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

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Reason / hazard
Potential for the Cassette Loading Lever to break.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Recall initiated
2026-02-04
Code info
Model Number: LVP-0004. UDI-DI: 00811505030320
Product quantity
18,444 installed bases
Voluntary mandated
Voluntary: Firm initiated
City
North Andover
State
MA
Country
United States
Event id
98699
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