Syringe pumps recalled over false motor movement system error messages
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 Syringe Pump, product code 40800BAXUS, UDI/DI 05413765852428, is the subject of an Urgent Medical Device Correction covering all serial numbers. The recall covers 10,101 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 Syringe Pump, Product Code 40800BAXUS, infusion pump
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 10,101
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 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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