sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library — Class II medical device recall Z-0670-2017
Terminated recall by Baxter Healthcare Corp., reported 2016-12-07, distributed nationwide. A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace spea
| Recall number | Z-0670-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-09-28 |
| Classified | 2016-11-29 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2018-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 00085412091570 |
Product
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
Reason for recall
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Machine access
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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.