Avanos Medical Recalls Respiratory Suction Device

Avanos Medical has recalled its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold (labeled 72-hour-use) after receiving complaints about cracked manifolds during use. “A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation,” a recall notice says. The manifold is used to provide access to the artificial airway of a child, infant, or neonate, without breaking the ventilation circuit, Avanos says.

Reduced ventilation and oxygenation can cause serious brain damage or death, especially in vulnerable patient populations (children, infants, and neonates), the notice says. “Additional risks from this issue include the possibility that a foreign body could be introduced through the cracked manifold, causing infection, damage to the airway, or a blocked endotracheal tube,” it says. To date, Avanos Medical has reported four injuries and one death related to the issue.