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Date: 10/2/2009 9:13:59 AM

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

REASON: 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.

distribution: nationwide.

Audience: Anesthesiology healthcare professionals, hospital risk managers

[UPDATED 09/21/2009] Class I Recall Notice added.

[Posted 09/11/2009] 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.

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.

[09/21/2009 - Recall Notice - FDA]
[09/10/2009 - Press Release - Smiths Medical]

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