The FDA has placed Draeger's removal of VentStar Resus Neo breathing circuit hoses in its most serious recall category, Class I, according to the FDA's updated recall notice, posted Oct. 2. The disposable circuit carries breathing gas from a source to infants weighing up to 22 pounds.
"The FDA has identified this recall as the most serious type," the agency said. As of Sept. 3, Draeger had reported no serious injuries or deaths linked to the problem, according to the FDA.