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Recall Observatory FDA recall evidence

Device product

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Z-2274-2026

February 04, 2026

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 98699
Status
Ongoing
Classification
Class II
Quantity
18,444 installed bases
Official record key
device-enforcement:Z-2274-2026

Official wording

Reason: Potential for the Cassette Loading Lever to break.

Code information: Model Number: LVP-0004. UDI-DI: 00811505030320

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the Cassette Loading Lever to break.