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Recall Observatory FDA recall evidence

Device product

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

Z-0848-2026

November 03, 2025

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 97939
Status
Ongoing
Classification
Class II
Quantity
15,862 units
Official record key
device-enforcement:Z-0848-2026

Official wording

Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.