Recall Z-0348-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
| Date | Nov 8, 2024 (initiated Oct 2, 2024) |
| Status | Open, Classified |
| Reason | The door on the Spectrum IQ Infusion pump may not be able to fully close. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 8 units |
| Distribution | GA, ID |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation, Mar 31, 2023 |