Baxter SIGMA Spectrum Infusion Pump with Master Drug Library — Class I medical device recall Z-0122-2021
Terminated recall by Baxter Healthcare Corporation, reported 2020-10-28, distributed nationwide. Baxter is updating the device IFU for safety communication regarding cleaning practices.
| Recall number | Z-0122-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-06-30 |
| Classified | 2020-10-22 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BM, BS, CA, GY, JM, TT |
| Quantity | 152,539 units |
| UPC / GTIN / UDI-DI | 00085412498683 |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Reason for recall
Baxter is updating the device IFU for safety communication regarding cleaning practices.
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-0122-2021. 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.