Recall archive / FDA device enforcement
Spectrum IQ Infusion Pump, Product Code 3570009 — FDA record Z-2415-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Spectrum IQ Infusion Pump, Product Code 3570009
- 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.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2415-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: AZ, FL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 14, 2025
- Center classification date
- Aug 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.