Recall Z-2530-2024 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
| Date | Aug 7, 2024 (initiated Jun 14, 2024) |
| Status | Open, Classified |
| Reason | Improperly performed testing prior to release |
| Root cause | Under Investigation by firm |
| Action | The impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation, Mar 31, 2023 |