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Tracheotomy Tubes Recalled After Deaths

Aug 6, 2004 | AP

A brand of tracheotomy tubes is being recalled because it can break apart in the neck, a defect linked to two deaths that prompted federal health officials Friday to urge that patients get prompt replacements.

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.

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