Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend.
Lot numbers from 1631477 to 1923406 inclusive.
Only devices intended for neonatal and paediatric use are affected.
Only tubes with an integrated connector that does not allow for use of a disconnect wedge (TR3) are affected.
Examples of accessories that can be used with the affected tubes include: speaking valves, heat moisture exchangers, and breathing circuit connectors.
A design modification was implemented in November 2010 to address this problem.