Pediatric Tracheal Tube Recall: Pose Risk of Serious Injury or Death

A recall has been issued for 17 different types of Portex pediatric tracheal tubes due to a potential defect that could cause some of the tubes to have internal diameters that are smaller than they are supposed to be. This could result in difficulty clearing secretions from the device or the airway, potentially leading to an airway obstruction.

The nationwide pediatric tracheal tube recall was posted by the FDA on September 10, as a Class I recall, meaning use of the product carries a reasonable probability of serious injury or death. However, no reports of involving death or serious injury have been associated with the defective tracheal tubes, according to a statement issued by Smiths Medical, which manufactured the devices.

The recall applies to several variations of Portex Uncuffed Pediatric-Sized Tracheal Tubes made before September 2009, including sizes of 2.5, 3.0 and 3.5mm. A complete listing of the recalled tracheal tubes is available in the recall notice posted by the FDA.

The small diameters could cause problems inserting or removing the suction catheter and could make it difficult to clean out secretions. This could cause an obstruction in the patient’s airway or an inability to ventilate the patient.

Smiths Medical is instructing all heath care professionals and other customers to return any unused tracheal tubes affected by the recall. However, the company indicates that there is no evidence that it is necessary to remove tubes currently in use with a patient, and recommends that customers use a company-supplied Guidance Chart for suction catheter sizes if suctioning of one of the affected tracheal tubes is required.