Baxter Novum IQ Syringe Pump Design Issue Recall
Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall with no reported injuries, illnesses, or deaths in the source text. The issue is a functional malfunction (false syringe detection and interface lock) that does not pose an immediate serious health risk, qualifying it as a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corporation has identified a design issue affecting certain Novum IQ Syringe Pumps (product code 40800BAXUS, UDI/DI 05413765852428). The issue may cause the pump to falsely detect the presence of a syringe flange when no syringe is actually loaded. When this occurs, the pump's user interface becomes stuck on the "Remove Syringe" screen after an infusion is complete and the syringe is unloaded. Additionally, a System Error 21502 (Flange Sensor Failure) may appear.
This issue affects approximately 8,027 units distributed nationwide in the United States. The defect is limited to pumps manufactured or repaired after July 4, 2023. All serial numbers of pumps from that manufacturing date forward are subject to this recall. Customers should contact Baxter or their healthcare facility to determine if their syringe pump is affected and obtain repair or replacement instructions.
The recalled product
- Product
- Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 8,027
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 (2)
- UDI/DI 05413765852428
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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