Baxter SIGMA Spectrum Infusion Pump with Master Drug Library — Class I medical device recall Z-0530-2022
Ongoing recall by Baxter Healthcare Corporation, reported 2022-02-09, distributed nationwide. There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via
| Recall number | Z-0530-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-12-29 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BM, BS, CA, GY, JM, TT |
| Quantity | 146,502 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00085412498683 |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Reason for recall
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
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-0530-2022. 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.