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