July 21, 2022

FDA: Class I recall of certain Smiths Medical Medfusion Syringe Infusion Pumps

By: Judy Mathias

Editor's Note

The Food and Drug Administration on July 20 identified the recall by Smiths Medical of certain Medfusion 3500 and 4000 Syringe Infusion Pumps as Class I, the most serious.

The recall was initiated because of eight software malfunctions that affect different serial numbers and software versions.

There have been seven serious injuries and one death reported that are related to these issues.

Distribution dates were October 2004 to February 17, 2022.


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