Recall archive / FDA device enforcement
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Descr... — FDA record Z-1368-2026
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 Jan 13, 2026. 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
- Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
- Reason
- Pumps were released without full testing being performed, including occlusion alarm testing.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1368-2026
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 | Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
States: Ohio Countries: United States
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
- Feb 25, 2026
- Recall initiation date
- Jan 13, 2026
- Center classification date
- Feb 13, 2026
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.