# FDA recall Z-0971-2018

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2017-10-06.

## 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.

## Distribution

Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.

## Key facts

- **Recall number:** Z-0971-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2018-03-21
- **Termination date:** 2019-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Medina, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2018

## Citation

> AI Analytics. FDA recall Z-0971-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0971-2018. Source: US FDA. Licensed CC0.

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