Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Descript
FDA device recall Z-1368-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Pumps were released without full testing being performed, including occlusion alarm testing.
- Action taken
- Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 5
- Distribution
- States: Ohio Countries: United States
- Date initiated
- 2026-01-13
- Date posted
- 2026-02-13
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) | Baxter Healthcare Corporation | 2025-07-28 |