FDAClass IFebruary 9, 2022

Baxter Spectrum IQ Infusion Pumps recall

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Why was Baxter Spectrum IQ Infusion Pumps recalled?

There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.

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?

All serial numbers, GTIN 00085412610900.

Product
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Recalling firm
Baxter Healthcare Corporation
Quantity
241,304 units
Distribution
Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
Recall date
February 9, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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