FDAClass IAugust 18, 2021

Spectrum IQ Infusion System with Dose IQ Safety recall

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

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

System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.

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?

All Serial Numbers

Product
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Recalling firm
Baxter Healthcare Corporation
Quantity
130135 units
Distribution
United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
Recall date
August 18, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls