Z-2415-2025Class II

Spectrum IQ Infusion Pump, Product Code 3570009

Name: Z-2415-2025 Spectrum IQ Infusion Pump, Product Code 3570009
Creator: Baxter Healthcare Corporation
Published: 2025-07-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Spectrum IQ Infusion Pump, Product Code 3570009 on 2025-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2415-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-14
Posted: 2025-08-22
Recalling firm: Baxter Healthcare Corporation
Product: Spectrum IQ Infusion Pump, Product Code 3570009
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST
Quantity in commerce: 6 units
Distribution: US distribution to states of: AZ, FL
Product codes and lots: UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2415-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2415-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-22

Product code FRN

K230041Class IISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2023-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)