Class I recallOngoing

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

FDA · FDA event 96721 · FDA posted May 20, 2025

FDA posted May 20, 2025Record source last checked: 2026-10-27 12:58:53 UTC

What happened

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

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

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 04/24/2025 via USPS First Class Mail. The notice explained the issue, hazard, and requested the following: Actions to be Taken by Customers 1. For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered. 2. Please remove the set upon powering off the device. 3. Post the enclosed informational poster with Novum IQ LVPs in your facility. 4. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

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

Affected products and models

This FDA record lists Baxter Novum IQ LVP INFUSION SYSTEM by Baxter Healthcare Corporation.

Products affected by FDA event 96721
Model	Description	Lot / serial range	Manufactured	Status
Z-1767-2025	Z-1767-2025	All serial numbers	Not provided in the normalized record	Ongoing

Distribution: US and Canada
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Apr 24, 2025
Recall initiated
Date recorded by the FDA.
May 20, 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: 96721
Published: May 20, 2025
Source checked: 2026-10-27 12:58:53 UTC

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

View official record

How MedWatcher checks these sources

Class II recallOngoing

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

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Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

FDA · FDA event 96721 · FDA posted May 20, 2025

FDA posted May 20, 2025Record source last checked: 2026-10-27 12:58:53 UTC

Affected products and models

This FDA record lists Baxter Novum IQ LVP INFUSION SYSTEM by Baxter Healthcare Corporation.

Products affected by FDA event 96721
Model	Description	Lot / serial range	Manufactured	Status
Z-1767-2025	Z-1767-2025	All serial numbers	Not provided in the normalized record	Ongoing

Distribution

US and Canada

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

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

Follow Baxter Novum IQ LVP INFUSION SYSTEM

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Baxter Novum IQ LVP INFUSION SYSTEM recall — FDA event 96721

Follow Baxter Novum IQ LVP INFUSION SYSTEM

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