Summary
The FDA issued a Class I for Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS by Baxter Healthcare Corporation. Reason: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is power.
Details
Source
Device Recall
External ID
Z-1767-2025
Action Date
2025-05-28
Status
Ongoing
Category
device
Product Description
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Lot/Code Info: All serial numbers
Quantity Affected: 34,524 units
Reason for Recall
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
Distribution
US and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-24
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 147 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-1767-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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