Novum IQ Syringe infusion system, Product Code 40800BAXUS
Summary
The FDA issued a Class I for Novum IQ Syringe infusion system, Product Code 40800BAXUS by Baxter Healthcare Corporation. Reason: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms.
Details
Source
Device Recall
External ID
Z-0151-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Lot/Code Info: All Serial Numbers
Quantity Affected: 2023 units
Reason for Recall
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
Distribution
US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-13
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 171 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-0151-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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