Reuters: Regulatory News: Covidien to recall some lots of ventilation device: FDA

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Covidien to recall some lots of ventilation device: FDA Aug 15th 2012, 16:58 Wed Aug 15, 2012 12:58pm EDT Aug 15 (Reuters) - Covidien Plc, a maker of drugs and medical devices, is recalling some lots of its ventilation device after consumers complained of leakage of fluid, U.S. health regulators alerted on Wednesday. The U.S. Food and Drug Administration classified the recall as Class I, meaning that the affected products could cause serious health problems, even death. The recalled device, called the cuffed Shiley tracheostomy tube, is placed in the patients' windpipe during a surgical procedure to create an airway and provide a pathway to remove fluid from the trachea and lungs. The recall affects tubes manufactured between October 2009 and June 2012, and Covidien estimates that about 330,000 tubes were manufactured during this time, according to Rhonda Luniak, a company spokeswoman. "All of those (330,000) tubes are subject to the recall, but at this point, many of them would have already been used and discarded. So, we expect that there are about 34,000 that would remain unused and would then be subject to the recall," Luniak told Reuters. Some lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes are included in this recall, while all other sizes and styles of the tubes are unaffected, the FDA said in an alert posted on its website. Covidien recommends that physicians using the affected tube should replace it as soon as possible and return it to the company. The company's shares were trading marginally down at $57.28 on Wednesday afternoon on the New York Stock Exchange. Link this Share this Digg this Email Reprints

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