Baxter NovumIQ Syringe Infusion Pumps Recalled for Gasket Defect Risk
Baxter Healthcare is recalling 149 NovumIQ syringe infusion pumps with incorrectly installed gaskets that could allow fluid ingress during cleaning or after IV fluid spills.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect with potential for fluid ingress into a medical infusion device. No hospitalizations, injuries, or illnesses have been reported. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Baxter Healthcare Corporation is recalling 149 units of the Baxter NovumIQ Syringe Infusion System due to an incorrectly installed gasket in the affected units. Affected units are identified by specific serial numbers.
The gasket defect creates a risk of fluid ingress. This fluid ingress could occur during cleaning procedures or as a result of an IV fluid spill near the device. Fluid ingress into the infusion pump could potentially compromise the device's integrity.
The recall affects 149 units distributed nationwide across 19 states: Arkansas, California, Florida, Iowa, Indiana, Louisiana, Missouri, Montana, North Carolina, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
The recalled product
- Product
- Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 149
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 (20)
- UDI/DI 05413765852428
- Serial Numbers: 02A220600103
- 02A221100387
- 02A240800201
- 02A230300471
- 02A240800161
- 02A220600112
- 02A230100474
- 02A240800343
- 02A230400357
- 02A240800175
- 02A220700259
- 02A230200471
- 02A240800710
- 02A230600165
- 02A240800223
- 02A220700176
- 02A230200487
- 02A240900081
- 02A230600175
Distribution
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