Recall Z-1775-2024 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
| Date | May 3, 2024 (initiated Mar 20, 2024) |
| Status | Open, Classified |
| Reason | One device was improperly performed testing prior to release from a Service Center. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1 pump |
| Distribution | US Nationwide distribution in the state of Massachusetts. |
| 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 |