Federal regulators have assigned a formal severity rating to the recall of neonatal and infant breathing circuits pulled from hospitals nationwide, placing it in the middle of the FDA's three-tier system rather than the most serious category.
The agency classified the Medline recall of Hudson RCI neonatal and infant heated wire breathing circuits as Class II. That designation applies to devices that may cause temporary or reversible health problems, or, though unlikely, serious health problems. It sits below Class I, the tier reserved for devices that may cause serious injury or death.
