Baxter SIGMA Spectrum Infusion Pump with Master Drug Library — Class II medical device recall Z-0971-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-03-21, distributed in DC, PR. Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, th
| Recall number | Z-0971-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Medina, NY, United States |
| Recall initiated | 2017-10-06 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-04-11 |
| Distributed | DC, PR |
| Countries outside the US | CA |
| Quantity | 173,375 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00085412091570 |
| Model numbers | 35700ABB, 35700BAX |
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Reason for recall
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
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-0971-2018. 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.