Avanos Medical Recalls Certain BALLARD ACCESS Closed Suction Systems For Pediatric Use Citing Ventilation Risk
- Avanos Medical Inc (NYSE: 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.
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