FDA Device recall Z-2530-2024
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 by Baxter Healthcare, citing improperly performed testing prior to release.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2530-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-14 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason
Improperly performed testing prior to release
Identifiers
| code_info | Product Code: 35700BAX2. Serial Number: 2158913. |
|---|
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-2530-2024%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.