Pediatric, Neonatal and Flextend Tracheostomy Tube Recall Issued

The FDA is warning that recalled Smiths Medical tracheostomy tubes could lead to severe injury or death due to problems disconnecting them from accessories. 

The Smiths Medical Bivona Neonatal, Pediatric and Flextend tracheostomy tubes recall was designated as a class 1 medical device recall on February 23, suggesting that the FDA believes the problems with the device are likely to cause serious injury or death.

Smith Medical originally sent out letters alerting its customers to problems with the tubes in late November.

Health care professionals have reported that it takes significant effort, and sometimes excessive force, to detach the tubes from accessories. The FDA warns that the amount of force used could dislodge the tracheostomy tube from the patient, which could lead to serious injury or death, especially if there is no replacement tube immediately available.

The FDA did not indicate whether there had been any injuries or deaths associated with the recall.

The recall affects Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes with the integrated connector that does not require use of a disconnect wedge. The affected tubes have lot numbers of 1631477 through 1923406. They were manufactured from August 29, 2009 through January 29, 2011.

The tubes are intended to provide airway access for a tracheostomized patient for up to a month and can be reused five times on a single patient. They are used in both health care facilities and in home care environments.

Smiths Medical has called for customers to identify and quarantine affected tubes, complete a confirmation form (pdf) and then fax or email that form back to the company. Their customer service will contact those customers and schedule replacements and returns.