Recall Z-2415-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Spectrum IQ Infusion Pump, Product Code 3570009
| Date | Aug 22, 2025 (initiated Jul 14, 2025) |
| Status | Open, Classified |
| 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 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 | 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 | 6 units |
| Distribution | US distribution to states of: AZ, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation, Mar 31, 2023 |