FDA designates Class 1 recall for tracheostomy tubes

Editor's Note

The US Food and Drug Administration (FDA) has designated the recall of Smiths Medical’s Bivona Neonatal/Pediatric and Adult Tracheostomy tubes as a Class 1, the most severe category indicating risk of serious injury or death.

According to the agency’s September 18 report, the recall is due to a manufacturing defect that may cause the securement flange to tear.   Two deaths and 35 injuries have been reported.

Specifically, the recall affects the Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tubes and the Bivona Aire-Cuf, TTS, Cuffless FlexTend, TTS FlexTend Adult Tracheostomy Tubes. According to the FDA report, these devices should be thrown away.