The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals that Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae, which were observed during mechanical ventilation of patients. Certain lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes are included in this product recall. See the FDA website, link provided below, for model and lot numbers of affected product. All other sizes and styles of Shiley tracheostomy tubes are unaffected by this action. Affected tracheostomy tubes were manufactured and distributed from October 1, 2009, to June 26, 2012.
Customers should return all Shiley tracheostomy tubes from the affected models and lots to Covidien. If one of the recalled tubes is already in use in a patient, Covidien recommends that the tube be replaced as soon as clinically appropriate as determined by the patient's physician. If the physician advises leaving the tracheostomy tube in place, Covidien strongly encourages that the frequency of direct patient observation be increased.
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