Class I recallOngoing

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 95891

FDA · FDA event 95891 · FDA posted Jan 8, 2025

FDA posted Jan 8, 2025Record source last checked: 2026-10-27 12:56:41 UTC

What happened

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Fresenius Kabi notified consignees on 12/06/2024 via "URGENT - Medical Device Recall" letter. Consignees were instructed to do the following: 1. Review the facilities list of affected Serial Numbers and post the list in a public place. 2. If an LVP exhibits a Pump Problem during use, remove the LVP from circulation, and notify Fresenius Kabi. 3. Inform potential users of the product within your organization of this notification. 4. Notify customers if product was further distributed. 5. Complete and return the Customer Reply Form included in the letter to acknowledge receipt.
Customers will be contacted by a Fresenius Kabi service representative to create a plan for repairing any affected LVPs at your facility at no cost. Fresenius Kabi will also repair LVPs that may encounter pneumatic valve failures at no additional charge.
For customer support and questions, call 1-855-354-6387 normal hours are from Monday thru Friday 8:30am-5pm Easter Time, after hours supported by voicemail messaging or email: Ivenix_support@fresnius-kabi.com.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), Large Volume Pump by Fresenius Kabi USA, LLC.

Products affected by FDA event 95891
Model	Description	Lot / serial range	Manufactured	Status
Z-0763-2025	Z-0763-2025	Model Number: LVP-0004, UDI Number: 00811505030320. Serial Numbers: 9233532106, 9233421830, 9233421828, 9233532158, 9233522076, 9233522041, 9233421833, 9233421829, 9233421808, 9233421654, 9233421626, 9233421621, 9233321340, 2215401517, 2215401545, 9233421789, 9233421809, 9233532167, 9233532100, 9233522070, 9233421825, 9233421824, 9233421794, 9233421783, 9233421781, 9233421771, 9233421768, 9233421756, 9233421736, 9233421713, 9233421702, 9233421617, 9233421611, 9233391513, 9233391491, 9233532098, 9233421822, 9233421797, 9233421678, 9233421666, 9233421601, 9233532114, 9233421792, 9233421766, 9233421687, 2215401372, 9233522040, 9233522037, 9233421764, 9233421752, 9233421665, 9232490602, 9233522062, 9233421817, 9233421832, 9233522094, 9233421805, 9233421740, 9233532161, 9233532111, 9233522061, 9233421836, 2212200949, 2212200956, 2212200959, 2212200960, 2212200964, 2212200965, 2212200983, 2212200999, 2212201000, 2212201001, 2212201006, 2212201008, 2212201009, 2212201011, 2212201017, 22122	Not provided in the normalized record	Ongoing

Distribution: US distribution to states of: ID, MN, NV, TX, VA, WI.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Dec 6, 2024
Recall initiated
Date recorded by the FDA.
Jan 8, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 27, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 95891
Published: Jan 8, 2025
Source checked: 2026-10-27 12:56:41 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 95891

FDA · FDA event 95891 · FDA posted Jan 8, 2025

FDA posted Jan 8, 2025Record source last checked: 2026-10-27 12:56:41 UTC

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), Large Volume Pump by Fresenius Kabi USA, LLC.

Products affected by FDA event 95891
Model	Description	Lot / serial range	Manufactured	Status
Z-0763-2025	Z-0763-2025	Model Number: LVP-0004, UDI Number: 00811505030320. Serial Numbers: 9233532106, 9233421830, 9233421828, 9233532158, 9233522076, 9233522041, 9233421833, 9233421829, 9233421808, 9233421654, 9233421626, 9233421621, 9233321340, 2215401517, 2215401545, 9233421789, 9233421809, 9233532167, 9233532100, 9233522070, 9233421825, 9233421824, 9233421794, 9233421783, 9233421781, 9233421771, 9233421768, 9233421756, 9233421736, 9233421713, 9233421702, 9233421617, 9233421611, 9233391513, 9233391491, 9233532098, 9233421822, 9233421797, 9233421678, 9233421666, 9233421601, 9233532114, 9233421792, 9233421766, 9233421687, 2215401372, 9233522040, 9233522037, 9233421764, 9233421752, 9233421665, 9232490602, 9233522062, 9233421817, 9233421832, 9233522094, 9233421805, 9233421740, 9233532161, 9233532111, 9233522061, 9233421836, 2212200949, 2212200956, 2212200959, 2212200960, 2212200964, 2212200965, 2212200983, 2212200999, 2212201000, 2212201001, 2212201006, 2212201008, 2212201009, 2212201011, 2212201017, 22122	Not provided in the normalized record	Ongoing

Distribution

US distribution to states of: ID, MN, NV, TX, VA, WI.

Units affected

See official FDA record

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

FDA · FDA event 99557Posted Aug 31, 2026

Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 95891

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What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ivenix Infusion System (IIS), Large Volume Pump recall — FDA event 95891

Follow Ivenix Infusion System (IIS), Large Volume Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline