Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA device recall Z-0348-2025 · posted 2024-11-08 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- The door on the Spectrum IQ Infusion pump may not be able to fully close.
- Action taken
- Baxter Healthcare notified its consignees on 10/03 and 04/2024 via telephone. The call included information regarding the problem with the device, risk to health, and requested the affected units be removed from service pending inspection. On-site inspections to assess for impact and offer replacement, were scheduled.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 8 units
- Distribution
- GA, ID
- Date initiated
- 2024-10-02
- Date posted
- 2024-11-08
- Location
- Deerfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectrum IQ Infusion System with Dose IQ Safety Software (K230041) | Baxter Healthcare Corporation | 2023-03-31 |