Recall Z-0776-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
| Date | Dec 27, 2024 (initiated Nov 19, 2024) |
| Status | Open, Classified |
| Reason | Devices were identified as released after repair without full testing being performed, which includes flow testing. |
| Root cause | Process control |
| Action | Customers were contacted via telephone beginning 11/19/24. Baxter Healthcare is calling to notify you of a potential issue with the Spectrum infusion pump. One of your devices has been identified as released after repair without full testing being performed, which includes flow testing. Baxter is requesting the return of the impacted infusion pump to perform all tests required and confirm that the infusion pump performs as expected. As part of this process, we need to make you aware of the potential hazard associated with flow related issues. Flow issues may cause excessive therapy, free-flo |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the states of AL, IN. |
| 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 |