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.
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