Avanos Medical recalled 1,000 catheters April 21 with a Class I warning, the most serious type, because of cracked parts that can increase the risk of delayed or prevented ventilation. One death and four injuries have been reported.
Inadequate ventilation can lead to serious brain damage or death, and the cracks also carry risks of foreign objects entering the tube and causing infection, damaging the airway or blocking the endotracheal tube, the FDA said.
The company sent a warning letter Feb. 3 to its customers, recommending users check for cracks and quarantine unused Ballard Access Closed Suction Systems for Neonates/Pediatrics with Y-Manifold and ones with an Elbow Manifold.