The company said some customers have experienced difficulty disconnecting accessories from the connectors of the affected devices. Smiths Medical said it was recalling only lot numbers 1631477 through 1923406 of its Bivona, Neonatal, Pediatric and Flextend Tracheotomy Tubes.
A tracheotomy is an opening in the trachea made to help a 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, officials at Health Canada said.
Some customers were unable to disconnect the accessory, or excessive force led to removal of the tube. Pulling a tube out can result in a life-threatening situation, and emergency intervention by experts may be required in some cases to reinsert the tube and prevent suffocation, Smiths Medical said.
Canadians who care for an infant or child who uses this device, and have purchased or used Bivona Neonatal, Pediatric and Flextend Tracheotomy Tubes, should consult their healthcare practitioners, Health Canada officials said.
Contact Smiths Medical at 905-477-2000 ext. 135 with any questions -- or visit the company's Web site, complete the "Confirmation Form" and return it to the company by fax to 905-477-2144 or by e-mail to firstname.lastname@example.org.
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