FDA Device recall Z-0714-2021
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administra…
- FDA Device
- Class II
- ongoing
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administra… by Baxter Healthcare, citing there is a potential software error during programming.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-23 |
| Published | 2020-12-30 |
| 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) - Product Usage: intended to be used for the controlled administration of fluids.
Reason
There is a potential software error during programming.
Identifiers
| code_info | Product Code 35700BAX2, GTIN 00085412498683 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2021%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.