Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Summary
The FDA issued a Class I for Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump by Baxter Healthcare Corporation. Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) d.
Details
Source
Device Recall
External ID
Z-2333-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Lot/Code Info: UDI/DI 05413765852428, All Serial Numbers
Quantity Affected: 10,101 units
Reason for Recall
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Distribution
US distribution including Puerto Rico and OUS (International) Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-04
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2333-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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