Smiths Medical has recalled and removed Bivona neonatal/pediatric and adult tracheostomy tubes due to a manufacturing defect that can cause the securement flange of the device to tear, which can cause loss of ventilation and loss of protected airway.
The FDA identified this recall as the most serious type, with a risk of injury or death when continuing to use the device, according to a Sept. 18 news release from the agency.
Smiths medical sent customers an urgent medical device notification advising for all Bivona Aire-Cuf, TTS, uncuffed, mid-range neonatal/pediatric tracheostomy tubes and Bivona Aire-Cuf, TTS, cuffless FlexTend, TTS FlexTend adult tracheostomy tubes to be thrown away and to fill out a customer response form to Smiths Medical.
There have been 35 reported injuries, the release said.