CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Ivenix Infusion System (IIS), Large Volume Pump recalled

Fresenius Kabi USA is recalling Ivenix Infusion System (IIS), Large Volume Pump, distributed nationwide in the US. The recall was initiated on 3 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: LVP-0004. UDI-DI: 00811505030320.

Quantity recalled15,862 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0848-2026
FDA event ID: 97939
Recalling firm: Fresenius Kabi USA, North Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Nov 2025
FDA classified: 1 Dec 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Nov 2025	Recall initiated by company
1 Dec 2025	Classified by FDA	+28 days
10 Dec 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide California Colorado Florida Georgia Idaho Illinois Maryland Michigan Minnesota Mississippi Nebraska New Jersey Nevada Oklahoma Oregon South Carolina Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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