Recall Z-2415-2025
Baxter Healthcare Corporation · initiated July 14, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Codes / lots: UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
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.
FDA-determined cause: Nonconforming Material/Component
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
Details
- Recall number
- Z-2415-2025
- Initiated
- July 14, 2025
- Posted by FDA
- August 22, 2025
- Product code
- FRN – Pump, Infusion
- Quantity
- 6 units
- Distribution
- US distribution to states of: AZ, FL
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL