FDA Device recall Z-0121-2021
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- FDA Device
- Class I
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class I recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) by Baxter Healthcare, citing baxter is updating the device IFU for safety communication regarding cleaning practices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0121-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-06-30 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reason
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Identifiers
| code_info | Product Code: 35700BAX, All Serial Numbers; GTIN 00085412091570 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0121-2021%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.