Spectrum IQ Infusion Pump, Product Code 3570009
FDA device recall Z-2415-2025 · posted 2025-08-22 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 6 units
- Distribution
- US distribution to states of: AZ, FL
- Date initiated
- 2025-07-14
- Date posted
- 2025-08-22
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectrum IQ Infusion System with Dose IQ Safety Software (K230041) | Baxter Healthcare Corporation | 2023-03-31 |