Smiths Medical Recalls Neonatal, Pediatric and Flextend Tracheostomy Tubes Throughout North America

Health Canada just announced that Smiths Medical has recalled its Neonatal, Pediatric, and Flextend Tracheostomy Tubes throughout North America.

A tracheostomy is an opening in the trachea that is made to help the patient breathe after surgery, or if there is a blockage in the patient’s airway. The recalled kits are used to help keep the opening clear and clean.

Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes bearing lot numbers 1631477 through 1923406 are involved.

The recalled tubes are Class 2 medical devices and used on the pediatric population in hospital as well as in home settings. There have been 22 complaints concerning the disconnection problem.

According Smiths Medical, the recall has been initiated becomes some customers have experienced 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 create a life-threatening situation. In some cases, emergency intervention by experts may be required to reinsert the tube to prevent suffocation.

Consumers who purchased or have used Bivona® Neonatal, Pediatric, and Flextend Tracheostomy Tubes should:

• • Consult a healthcare practitioner if they care for an infant or child that uses this device.
• • Identify all affected unused device in inventory and segregate the devices to a quarantined location.
• • Contact Smiths Medical at 1.905.477.2000 ext. 135 with any questions regarding the Customer Information Bulletin; review product “Instructions for Use”; and visit the company’s website at http://www.smiths-medical.com/. Once there, complete the “Confirmation Form,” and return it to the company by fax to 1.905.477.2144 or by email to melissa.lake@smiths-medical.com.

To report suspected adverse reaction to these or other health products, the Canada Vigilance Program of Health Canada can be reached, toll-free, at 1.866.234.2345, or by completing a Canada Vigilance Form at http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php. The form can be returned via fax to 1.866.678.6789; email to CanadaVigilance@hc-sc.gc.ca; on the Internet via www.healthcanada.gc.ca/medeffect; or by mail to the Canada Vigilance Program,
Marketed Health Products, Directorate
Ottawa, Ontario, Address Locator 0701C
K1A 0K9.