February 10, 2023

FDA: Class I recall of Smiths Medical CADD Infusion System Administration Sets, Cassette Reservoirs

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on February 2 identified the recall by Smiths Medical of certain CADDTM Infusion System Administration Sets and Cassette Reservoirs as Class I, the most serious.

The recall was initiated because of tubing occlusion and false “no disposable attached” alarm issues, which may cause delays, interruptions, or under delivery of therapy.

Smith Medical reports that there have been 1,571 incidents, 14 injuries, and 2 deaths related to tubing occlusion and 9,101 incidents, 11 injuries, and no deaths related to false alarm issues.

Distribution dates were June 15, 2018, to present.

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