Summary
The FDA issued a Class II for Spectrum IQ Infusion Pump, Product Code 3570009 by Baxter Healthcare Corporation. Reason: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickl.
Details
Source
Device Recall
External ID
Z-2415-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
Spectrum IQ Infusion Pump, Product Code 3570009
Lot/Code Info: UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
Quantity Affected: 6 units
Reason for Recall
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Distribution
US distribution to states of: AZ, FL
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-14
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2415-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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