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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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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