Health Canada is informing Canadians and Canadian healthcare practitioners that Smiths Medical is conducting a North American voluntary recall of certain lot numbers (see below) of Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes. A tracheostomy is an opening in the trachea made to help the patient breathe after surgery, or if there is a blockage in the airway. The kits are used to help keep the opening clear and clean. According to the company, the recall is due to some customers experiencing difficulty disconnecting accessories from the connectors of the affected tubes. Some customers were also unable to disconnect the accessory or excessive force led to removal of the tube. If the tube is accidentally pulled-out, this can be a life-threatening situation. In some cases, emergency intervention by experts may be required to reinsert the tube to prevent suffocation.
RecallTracker