Federal regulators have flagged a recall of breathing circuits used on some of the most fragile patients in any hospital: newborns and infants on ventilators. Medline is pulling all lots of certain Hudson RCI neonatal and infant heated wire breathing circuits after reports that an electrical connector can discolor, melt, smoke, or give off a burning odor.
The Center for Devices and Radiological Health issued an early alert on the breathing circuits, a designation the FDA uses to notify the public about a potentially high-risk device issue while its review is still underway. Medline is telling hospitals to immediately identify and quarantine affected circuits and to destroy them once the recall response form is complete.