Portex Pediatric-Sized Tracheal Tubes
Smiths Medical Issued An Urgent Device 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.
Description of the Issue:
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. To date, the company has not received any reports of death or permanent injury related to this issue.
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