Recall Of Portex® Pediatric-Sized Tracheal Tubes

Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009.

A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient’s airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is a reasonable probability of serious injury and/or death, although to date the company has not received any reports of death or permanent injury.

For more information, including recommended action to take if you use these tubes, click on this link:  http://www.fda.gov/Safety/Recalls/ucm181955.htm

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