Portex Uncuffed Pediatric-Sized Tracheal Tubes
(sizes 2.5, 3.0 and 3.5 mm) have been recalled by Smiths Medical. According to the company, there is a reasonable probability that these Tracheal Tubes could cause serious injury and/or death. To date, Smiths Medical has not received any reports of death or permanent injury related to these recalled devices.
According to the recall notice, 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 one of these Tracheal Tubes 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.
This recall applies to Portex Uncuffed Pediatric-Sized Tracheal Tubes manufactured prior to September 2009. The following product codes are involved in this recall:
* 100/105/025 Portex® Tracheal Tube, Oral/Nasal, Ivory
* 100/105/030 Portex® Tracheal Tube, Oral/Nasal, Ivory
* 100/105/035 Portex® Tracheal Tube, Oral/Nasal, Ivory
* 100/111/025 Portex® Tracheal Tube, Oral/Nasal, Siliconized
* 100/111/030 Portex® Tracheal Tube, Oral/Nasal, Siliconized
* 100/111/035 Portex® Tracheal Tube, Oral/Nasal, Siliconized
* 100/126/025 Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
* 100/126/030 Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
* 100/126/035 Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
* 100/134/030 Portex® Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear
* 100/134/035 Portex® Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear
* 100/141/025 Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized
* 100/141/030 Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized
* 100/141/035 Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized
In a Recall Notice sent directly to all customers, Smiths Medical is instructing them to return all unused Tracheal Tubes.
The company’s recall notice advises that if a Tracheal Tube is currently in use with a patient, there is no evidence to suggest its immediate removal is necessary. If suctioning of a Tracheal Tube currently in use is required, Smiths Medical recommends that customers refer to a company-supplied Guidance Chart for suction catheter sizes, available at www.smiths-medical.com.Clinicians who choose to use larger-than-recommended suction catheters should base this decision on sound clinical judgment and use caution, to assure the suction catheter readily passes through and can be readily withdrawn from the Tracheal Tube.
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