Spectrum IQ Infusion pump, Product Code 357009
FDA device recall Z-1810-2024 · posted 2024-05-13 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There is a potential for cracks on the mount of the front panel of the device.
- Action taken
- Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 9 units
- Distribution
- US Nationwide distribution in the states of Ohio, Wisconsin.
- Date initiated
- 2024-04-09
- Date posted
- 2024-05-13
- Location
- Deerfield, IL
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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 |