Portex Uncuffed Pediatric-Sized Tracheal Tubes:Nationwide recall due to risk of obstruction and inability to ventilate patient

FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 11 Sep 2009 23:18:31 -0500 (CDT)

Title: Portex Uncuffed Pediatric-Sized Tracheal Tubes:Nationwide recall due to risk of obstruction and inability to ventilate patient

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.

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

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm 

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx. 

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). 

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420 

			GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA)
			· 5600 Fishers Lane

			· Rockville MD 20857
			· 800-439-1420