Smith Medical ASD, Inc., a New Hampshire based medical device manufacturer, has instituted a recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) as some were incorrectly manufactured and could cause patients' airways to be partially or completely obstructed. Smith is working with the U.S. Food & Drug Administration (FDA), which has classified this as a Class I recall – meaning that there is a reasonable probability of serious injury and/or death.

Class I medical device recall

This FDA Class I medical device recall involves the following 17 different tracheal tube medical devices which were manufactured prior to September 01, 2009 and distributed from September 1, 2004 through August 31, 2009:

Product Code	Product Description
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
100/127/025	Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/030	Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/035	Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
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

According to a press release from Smith Medical on the FDA's website:

Some of the products were manufactured with internal diameters smaller than indicated on the labeling. The clinician may have difficulty passing through or withdrawing the suction catheter. Use of this device may also include the inability to remove secretions from the device and from the patient’s airway. This may result in partial or complete obstruction of the patient’s airway and the inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient.

The company and the FDA recommend that customers review their inventory and segregate any unused products before September 2009 and within its expiration date and return any unused products to the company, who can be reached at 1-800-348-6064.

Patients using tracheal tubes should check with their doctors to make sure that they are not given one of these defective medical devices in order to avoid personal injuries or wrongful deaths. If you are victim of a tracheal tube defect, contact an attorney to learn your legal rights.