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The recall was issued in response to reports of volume leakage and disconnection between the inner and outer cannulae. Only certain lots of the size 8 tubes are being recalled. Unused products should be returned to the company, while currently used products should 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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