Baxter SIGMA Spectrum Infusion Pump with Master Drug Library — Class II medical device recall Z-0713-2021
Ongoing recall by Baxter Healthcare Corporation, reported 2020-12-30, distributed nationwide. There is a potential software error during programming.
| Recall number | Z-0713-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BM, BS, CA, GY, JM, TT |
| Quantity | 293,926 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00085412091587 |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason for recall
There is a potential software error during programming.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0713-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.