Baxter Spectrum IQ Infusion Pump, Product Code 3570009
FDA device recall Z-1775-2024 · posted 2024-05-03 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- One device was improperly performed testing prior to release from a Service Center.
- Action taken
- The affected customer was contacted via on-site visit on March 20, 2024, and by phone call on March 22, 2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter for testing.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 1 pump
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Date initiated
- 2024-03-20
- Date posted
- 2024-05-03
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spectrum IQ Infusion System with Dose IQ Safety Software (K230041) | Baxter Healthcare Corporation | 2023-03-31 |