FDAClass IIDecember 30, 2020

Baxter Spectrum IQ Infusion System with Dose IQ Safety recall: Software Issue

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.

Why was Baxter Spectrum IQ Infusion System with Dose IQ Safety recalled?

There is a potential software error during programming.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code 3570009, GTIN 00085412610900

Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Recalling firm
Baxter Healthcare Corporation
Quantity
112,463 devices
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Recall date
December 30, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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