US FDA identifies recall of Avanos Medical's respiratory systems as most serious

Avanos Medical

21/04/2023 14:40

April 21 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday identified
the recall of Avanos Medical Inc's  AVNS.N  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.

 (Reporting by Pratik Jain in Bengaluru; Editing by Shailesh Kuber)
 ((Pratik.Jain@thomsonreuters.com;))