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

Baxter Novum IQ LVP Infusion System underinfusion risk recall

Baxter Healthcare is recalling the Novum IQ LVP Infusion System because the device may deliver less medication than intended when using standby mode or after being powered off with the set loaded.

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: The FDA classified this as a Class I recall. Under the rubric, FDA Class I recalls that do not meet the Critical threshold (no reported deaths or serious injuries explicitly stated) are scored as Severe (4).

Plain-English summary

Baxter Healthcare Corporation is recalling the Novum IQ LVP Infusion System (model REF 40700BAXUS, all serial numbers). The device poses a potential risk of underinfusion—delivering insufficient medication—when the standby mode feature is used or when the device is powered off while a medication set is loaded.

All affected units distributed in the US and Canada are included in this recall. Healthcare facilities and patients using this infusion system should stop use and contact Baxter Healthcare Corporation for guidance on replacement or repair options. Patients currently receiving infusions with this device should consult their healthcare provider immediately regarding their treatment.

The recalled product

Product
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Infusion System
Hazard
Affected units
34,524

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.

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