Novum IQ large volume pumps recalled over software anomalies causing blank screens
Baxter is issuing an urgent correction for Novum IQ Large Volume Pumps over software anomalies that may result in a blank Run screen. 43,922 units are affected.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I action, and the FDA classified this infusion pump correction as Class I.
Plain-English summary
The Novum IQ Large Volume Pump, product code 40700BAXUS, UDI/DI 05413765851797, is the subject of an Urgent Medical Device Correction covering all serial numbers. The recall covers 43,922 units distributed in the United States including Puerto Rico, and in Canada.
Baxter Healthcare Corporation issued the correction for the Novum IQ Large Volume Pump and Novum IQ Syringe Pump because of software anomalies that may result in a blank Run screen on both pump types, and a false motor movement system error on the syringe pump. The FDA classified the action as Class I, its most serious category.
Hospitals operating these pumps should follow Baxter's correction notice in full, including any interim instructions for checking that an infusion is running as programmed.
The recalled product
- Product
- Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 43,922
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 05413765851797
- All Serial Numbers
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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