Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes - Inadvertent Dislodgment - Class I Recall
MedSun: Newsletter #70, March 2012

FDA Medical Device Recalls

Some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes. If excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

Additional Information:

FDA Medical Device Recalls. Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes – Class I Recall. November 28, 2011.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm293062.htm