http://www.yourlawyer.com/topics/overview/shiley_tracheosoft Sat, 21 Nov 2009 23:36:38 -0800 pixel-app en http://www.yourlawyer.com/articles/read/8337 Sun, 08 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8337 Use: The device is an extended length cannula (tube) with accessory components used to provide an artificial airway to assist in the treatment of a variety of respiratory diseases and airway management in adults. The tube is inserted into a tracheostomy incision in a patients neck and trachea. The tracheostomy tube is secured in place through the tubes hub and flange assembly with the use of a holder or neck strap.

Recalling Firm: Nellcor/Tyco Healthcare
4280 Hacienda Drive
Pleasanton, CA 94588-2719

Reason for Recall: The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patients airway and significantly interfere with breathing and ventilation. This recall affects 73,355 disposable units that the firm has shipped to U.S. and international customers over the last four years.

FDA District: San Francisco

FDA Comment: Failure of the tracheostomy tube can allow the tube to migrate, leading to obstruction of the airway and subsequent lack of ventilation. Airway obstruction or failure to ventilate can lead to permanent neurological injury or death. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death. ]]> http://www.yourlawyer.com/articles/read/8323 Fri, 06 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8323
Recalled are Shiley TracheoSoft XLT Extended Length tracheostomy tubes. More than 73,000 were shipped to hospitals and other health organizations in the last four years.

There are 17 reports of part of that tubing breaking in a way that could let it slide down into the neck and block breathing, said Food and Drug Administration officials. Two of the reports involved patient deaths, and a third an injury.

Maker Nellcor/Tyco Healthcare says 80 percent of health organizations that bought the tubing have responded since it notified them of the recall on July 8. The recall was made public Friday.

The FDA said there's no way to know how many of the recalled tubes currently are implanted into patients or because the disposable tubing is supposed to be replaced monthly are being stored in their homes.

Patients or their families should call their doctors to see if they use the recalled brand, or check any home supplies, said FDA compliance officer Christy Foreman.

"We are recommending as soon as practical they find an alternative," she said. "It's urgent, because you can't predict" which tubes may break.

The tubing can be used on patients hooked to ventilators, in which case an alarm is supposed to sound if breathing is blocked. But tracheotomy recipients aren't necessarily hospitalized or even bed-bound, and quick action is required to restore breathing if the tubing breaks, Foreman said.

This is not standard tracheotomy tubing but a brand specially designed for certain patients who need a longer-than-usual version. Other extended-length brands are available, the FDA said.

The defect's cause hasn't been determined, and the recall covers all lots of that brand. ]]> http://www.yourlawyer.com/topics/overview/shiley_tracheosoft Fri, 06 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/shiley_tracheosoft Shiley TracheoSoft A variety of tracheotomy tubes has been recalled because they can break apart in the neck, a defect associated to two deaths that prompted federal health officials to advise patients to get replacements. The recalled product is the Shiley TracheoSoft XLT Extended Length Tracheotomy tubes. More than 73,000 were shipped to hospitals and other health organizations over the last four years.

There has been 17 reports of part of that tubing breaking in a way that could let it slide down into the neck and block breathing, said Food and Drug Administration officials. Two of the reports involved patient deaths and a third an injury. The FDA said there's no way to know how many of the recalled tubes currently are implanted into patients or because the disposable tubing is supposed to be replaced monthly are being stored in their homes.

The tubing can be used on patients hooked to ventilators, in which case an alarm is supposed to sound if breathing is blocked. But tracheotomy recipients aren't necessarily hospitalized or even bed-bound, and quick action is required to restore breathing if the tubing breaks, Foreman said. This is not standard tracheotomy tubing but a brand specially designed for certain patients who need a longer-than-usual version.

Other extended-length brands are available, the FDA said. The defect's cause hasn't been determined, and the recall covers all lots of that brand.

If you or a loved one suffered injuries from a Shiley TracheoSoft tube, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>