FDA Device recall Z-0775-2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX by Baxter Healthcare, citing devices were identified as released after repair without full testing being performed, which includes flow testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0775-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-19 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Reason
Devices were identified as released after repair without full testing being performed, which includes flow testing.
Identifiers
| code_info | GTIN 00085412091570; Serial Number: 779515 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0775-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.