Novum IQ Syringe Pump may falsely indicate infusion completion
Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.
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: FDA Class I classification mandates a minimum severity of Severe. The device may falsely indicate infusion completion while uninfused medication remains in the syringe, creating a risk of incomplete medication delivery to patients.
Plain-English summary
Baxter Healthcare Corporation has issued an urgent medical device correction for the Novum IQ Syringe infusion system (Product Code 40800BAXUS). The company identified a defect in which the pump may incorrectly display an 'Infusion Complete' alarm even though fluid remains uninfused in the syringe, particularly after the pump has triggered multiple downstream occlusion alarms.
This malfunction poses a risk of incomplete medication delivery. Patients or healthcare providers relying on the pump's alarm to confirm medication delivery may fail to recognize that uninfused fluid remains, potentially resulting in patients not receiving their full prescribed dose.
The recall affects 2,023 units with all serial numbers, distributed nationwide to 27 states: Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia.
Healthcare facilities and users of affected Novum IQ Syringe systems should review the urgent correction notice from Baxter and follow the manufacturer's recommended actions.
The recalled product
- Product
- Novum IQ Syringe infusion system, Product Code 40800BAXUS
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Syringe Pump
- Affected units
- 2,023
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
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