FDAClass IOctober 28, 2020

Spectrum IQ Infusion System with Dose IQ Safety recall

Spectrum IQ Infusion System with Dose IQ Safety Software

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

Baxter is updating the device IFU for safety communication regarding cleaning practices.

What should I do if I have this product?

Review the official FDA enforcement record for current 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, All Serial Numbers; GTIN 00085412610900

Product
Spectrum IQ Infusion System with Dose IQ Safety Software
Recalling firm
Baxter Healthcare Corporation
Quantity
146,224 units
Distribution
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
Recall date
October 28, 2020
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls