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FDA Drug & Medical Device Recall News & Comments 
Friday, September 11 2009

Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)

Audience: Anesthesiology healthcare professionals, hospital risk managers

Smiths Medical and FDA notified healthcare professionals about a nationwide voluntary recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). 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.

Tracheal Tube Recall - Press Release from Manfacturer

Smiths Medical is instructing customers to return all unused Tracheal Tubes and in their press release has provided recommendations for management of recalled product that is currently in use.

Read the complete MedWatch Safety summary, including a link to the firm's press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182084.htm


Posted by: DW AT 11:41 am   |  Permalink   |  Email
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