Public recall detail

North American Urgent Recall: Neonatal, Pediatric and Flextend Tracheostomy Tubes

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Recall Safety notice
Quick summary

Quick summary: North American Urgent Recall: Neonatal, Pediatric and Flextend Tracheostomy Tubes .

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: North American Urgent Recall: Neonatal, Pediatric and Flextend Tracheostomy Tubes .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

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.

What you 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 Airway TV Channel, according to the company.
  • Visit the Smiths Medical 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
Additional official information
Background{"text":"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."}
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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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