Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reported: December 30, 2020 Initiated: November 23, 2020 #Z-0713-2021
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Reason for Recall
There is a potential software error during programming.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 293,926 devices
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.. Recalled by Baxter Healthcare Corporation. Units affected: 293,926 devices.
Why was this product recalled? ▼
There is a potential software error during programming.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0713-2021.
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