The Food and Drug Administration (FDA) on Friday identified the recall of Avanos Medical Inc.’s artificial airway tube for children and infants as the most serious type, as its use could lead to serious injuries or death.
The medical device maker recalled 1,000 of its Ballard Access Closed Suction System tubes for children in February this year, after it received complaints from customers about cracked openings or manifolds during use of the tubes.
A cracked manifold can cause leaks in the respiratory circuit and can result in the patient receiving insufficient ventilation. The tubes are used for infants and children who are in need of mechanical ventilation.
The recalled devices were distributed between Oct. 20 last year and Jan. 23.
Avanos had received reports of four injuries and one death related to the issue, the FDA said.
The company did not immediately respond to a Reuters request for comment.
