Avanos Medical Recalls Certain BALLARD ACCESS Closed Suction Systems For Pediatric Use Citing Ventilation Risk

Avanos Medical Inc AVNS is recalling the Avanos BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or Elbow Manifold (labeled 72-hour-use).
The move comes after receiving complaints from customers about cracked manifolds during use. A cracked manifold can cause leaks in the respiratory circuit, which may lead to the patient receiving inadequate ventilation.
Inadequate ventilation and oxygenation can lead to serious brain damage or death, especially in vulnerable patients (children, infants, and neonates).
The FDA has identified this as the most serious type of recall.
Additional risks from this issue include possibly introducing a foreign body through the cracked manifold, causing infection, damage to the airway, or a blocked endotracheal tube.
Avanos Medical has reported four injuries and one death related to this issue.
The manifold of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics provides access to the artificial airway without breaking the ventilation circuit.
The BALLARD ACCESS Closed Suction manifold is indicated for use with the BALLARD ACCESS Closed Suction catheter to remove secretions from the artificial airway of children, infants, and neonates.
The company has issued a recall for 1,000 products distributed between October 2022-January 2023.
Price Action: AVNS shares are up 0.03% at $30.53 on the last check Friday.