FDA Updates Smiths Medical CADD System Recall to Class I

The FDA has issued an update on the Dec. 9, 2022, recall of certain Smiths Medical CADD infusion system administration sets and cassette reservoirs, deeming it a Class I recall because of the risk of serious injury or death.

The CADD infusion systems deliver controlled amounts of medications into a patient’s vein and are used in hospital, outpatient, and home settings.

The recall is for two potential issues: occluded tubing can prevent or under deliver medication and a false “no disposable attached” alarm can prevent pump use.

“Either of these recall issues can cause delay of therapy, interruption of therapy, or under-delivery of medication, which all have the potential to cause serious patient harm or death,” the agency said.

More than 19 million distributed products were affected. The company has reported 1,571 incidents, 14 injuries and two deaths related to the tubing occlusion issue and 9,101 incidents, 11 injuries and zero deaths related to the false alarm issue.