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Portex Pediatric Tracheal Tubes Recalled

September 2009

Pediatric tracheal tubes recalled. Various sizes of Portex Uncuffed Pediatric-Sized Tracheal Tubes have been recalled by Smiths Medical. The defective tubes are subject to a Class I recall, which means they pose a probable risk of serious injury or death.

Some of the tracheal tubes may have internal diameters that are smaller than they are supposed to be. This could result in difficulty removing secretions from the tube or airway, potentially leading to an airway obstruction. Seventeen different types of tubes in three different sizes are affected. A complete list of the recalled units can be found on the FDA's website.

Smiths Medical has instructed all customers to return any unused tracheal tubes involved in the recall. The company says that tubes currently in use with a patient don't have to be removed, and advises customers to use a company-supplied Guidance Chart for suction catheter sizes if suctioning a tracheal tube is necessary.

"Smiths Medical Issues Urgent Device Recall Of Portex Pediatric-Sized Tracheal Tubes." FDA Press Release. September 10, 2009.