The issue:
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.
Who is affected
Canadians who have purchased or used Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes.
What consumers should do
- Consult your healthcare practitioner if you care for an infant or child that uses this device.
- Identify all affected unused device in inventory and segregate it to a quarantine location, according to the company.
- Contact Smiths Medical at 905-477-2000 ext. 135 with any questions regarding the Customer Information Bulletin.
- View product
Instructions for Use, according to the company.
- Visit the company's website, complete the "Confirmation Form" and return it to the company by Fax to 905-477-2144 or by email to melissa.lake@smiths-medical.com
What Health Canada is doing
Canadians can be confident that Health Canada is monitoring the voluntary recall by Smiths Medical. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.
Background
The tubes are class 2 medical devices and are used on the pediatric population in hospital as well as in the home setting. There has been twenty two complaints concerning the disconnection problem, but none have been reported in Canada.
Details of Affected Devices:
Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes
Only Lot Numbers 1631477 through 1923406
For more information
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
How to report side effects to health products
To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:
Send us your feedback
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Media Enquiries:
Health Canada
(613) 957-2983
Public Enquiries:
(613) 957-2991
1-866 225-0709
SOURCE