Recall archive / FDA device enforcement
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 — FDA record Z-0348-2025
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 Oct 2, 2024. 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
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Reason
- The door on the Spectrum IQ Infusion pump may not be able to fully close.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 8 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0348-2025
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 | 00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
GA, ID
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
- Nov 20, 2024
- Recall initiation date
- Oct 2, 2024
- Center classification date
- Nov 8, 2024
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.