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Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intende...

FDA Recall #Z-0713-2021 — Class II — November 23, 2020

Recall #Z-0713-2021 Date: November 23, 2020 Classification: Class II Status: Ongoing

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.

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

293,926 devices

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

Code Information

Product Code 35700BAX, GTIN 00085412091587

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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