Product Wiki · Recalls · Government of Canada recall portal

North American Urgent Recall: Neonatal, Pediatric and Flextend… — recall 22654

Government of Canada recall portal · Canada · 2011-12-23

As described by Government of Canada recall portal: North American Urgent Recall: Neonatal, Pediatric and Flextend Tracheostomy Tubes

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Government of Canada recall portal
Recall identifier
22654
Date of alert
2011-12-23
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Communications and Public Affairs Branch
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/north-american-urgent-recall-n

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