The FDA has issued a Class 1 recall of a tracheostomy tube manufactured by Smiths Medical.
The Bivona Pediatric, Neonatal and Flextend tracheostomy tube is designed to provide direct airway access for a tracheostomized patient for up to 29 days. According to the recall notice, some customers have struggled to disconnect 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,” said the FDA. “This could lead to serious patient injury or death, especially if no replacement tube is immediately available."
Gary, Ind.-based Smiths Medical first warned purchasers of problems with the tube, and urged actions to correct for them, in November 2011.
Class 1 recalls are the most serious type of recall, issued for products deemed by the FDA to present a serious risk of injury or death.