Class I recallOngoing

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 96085

FDA · FDA event 96085 · Posted Feb 4, 2025

Published Feb 4, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

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 began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.

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), LVP Software LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 96085
Model	Description	Lot / serial range	Manufactured	Status
Z-1019-2025	Z-1019-2025	UDI-DI: 00811505030122. Software 5.9.2 and prior	Not provided in the normalized record	Ongoing

Distribution: US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Jan 10, 2025
Recall initiated
Date recorded by the FDA.
Feb 4, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96085
Published: Feb 4, 2025
Source checked: 2026-10-08 16:03:16 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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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

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FDA · FDA event 99063Posted Jun 25, 2026

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Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

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Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 96085

FDA · FDA event 96085 · Posted Feb 4, 2025

Published Feb 4, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 96085
Model	Description	Lot / serial range	Manufactured	Status
Z-1019-2025	Z-1019-2025	UDI-DI: 00811505030122. Software 5.9.2 and prior	Not provided in the normalized record	Ongoing

Distribution

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.

Units affected

See official FDA record

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

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 96085

Follow Ivenix Infusion System (IIS), LVP Software LVP-SW-0005

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA event 96085

Follow Ivenix Infusion System (IIS), LVP Software LVP-SW-0005

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