FDA warns Consort's King Systems on marketing

WASHINGTON | Tue Dec 1, 2009 10:02am EST

WASHINGTON Dec 1 (Reuters) - The U.S. Food and Drug administration ordered Consort Medical's (CSRT.L) King Systems Corp to cease marketing its oropharyngeal airway for uses not yet approved by the agency.

In a warning letter to King Systems, based in Noblesville, Indiana, FDA ordered the firm to stop marketing materials that describe the device as "intended for airway management in over 4 feet in height for controlled or spontaneous ventilation ... for difficult and emergent airway cases ... and (as) well-suited for ambulatory and office-based anesthesia."

FDA said the device was approved for use of "controlled ventilation during anesthesia" for short procedures in adults, when patients are considered at low risk of aspiration of stomach contents. (Reporting by Jackie Frank, editing by Gerald E. McCormick) ((Company news desk in Washington, +1 202 898 8400, washington.newsroom@thomsonreuters.com))

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