The Recall Desk
SevereFDA (Devices)·Z-1767-2025·Announced 2025-05-28

Baxter Novum IQ LVP Infusion System Recalled Due to Underinfusion Risk

Baxter is recalling the Novum IQ LVP Infusion System due to potential underinfusion when using standby mode or when powered off with the set loaded. The recall involves 34,524 units in the US and Canada.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA has classified this as a Class I recall. Per the rubric, Class I recalls cannot score below 4 (Severe). Although no injuries or illnesses have been reported, the potential for underinfusion in an infusion system poses risk of inadequate medication delivery to patients.

Plain-English summary

Baxter Healthcare Corporation is recalling the Novum IQ LVP Infusion System (REF 40700BAXUS) due to a potential for underinfusion. This hazard can occur when the device is placed in standby mode or powered off while the infusion set is loaded.

The recall impacts all serial numbers of the device. A total of 34,524 units have been distributed in the US and Canada.

Underinfusion means the device may fail to deliver the prescribed amount of medication. This poses a risk to patients dependent on the infusion system for medication delivery.

The recalled product

Product
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Infusion System
Hazard
  • underinfusion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category