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U.S. Department of Health and Human Services

Medical Devices

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Certain Cuffed Shiley Tracheostomy Tubes

Company, Product(s): Shiley Inflatable Cuff Tracheostomy Tubes

Recall Class: Class I

Date Recall Initiated: April 13, 2010

Product Names:

These tubes were distributed between November 2008 and September 2009.

The following link provides a chart with all Shiley inflatable cuff tracheostomy tubes that are part of this recall: http://www.fda.gov/Safety/Recalls/ucm209709.htm

Use:

Tracheostomy tubes are prescription devices used by the order of a physician.

A tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea). A tracheostomy tube is usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs.

Inflatable cuff tracheostomy tubes have a soft balloon around the far end of the tube that is inflated to seal off the space between the wall of the windpipe and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the windpipe.

Recalling Firm:

Nellcor Puritan Bennett Inc., doing business as Covidien Ltd.
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214

Reason for Recall: The company has voluntarily recalled this device because they may leak air, resulting in inadequate ventilation.

This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.

Public Contact: If you need assistance or have questions about this recall or your cuffed Shiley tracheostomy tubes, call Covdien Nellcor Puritan Bennett Customer Service available 24 hours a day, 7 days a week at 1-800-635-5267.

FDA District: Denver

FDA Comments:

Customers were notified of this recall by the company in a letter on April 13, 2010. The letter includes advice for healthcare facilities as well as patients and non-clinical caregivers. The letter is available on the Covidien website at http://respiratorysolutions.covidien.com/LinkClick.aspx? fileticket=GTn1%2f3%2f6cko%3d&tabid=234.Exit Disclaimer

Any adverse reactions experienced with the use of this product or quality problems may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

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