—#215246

Product

Spectrum IQ Infusion Pump, Product Code 3570009

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K230041
Affected lot / code info: UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US distribution to states of: AZ, FL

Timeline

Recall initiated: 2025-07-14
Posted by FDA: 2025-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.