Medical device manufacturer, Covidien, has issued a field safety notice concerning the recall of certain size 8 Shiley Reusable Cannula Cuffed Tracheostomy Tubes.
The manufacturer has received customer reports on certain size 8 Shiley reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed.
If one of the recalled tubes is already in use in a patient, the manufacturer recommends that the tube 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, the manufacturer strongly encourages that the frequency of direct patient observation be increased. Unused products from the affected product codes and lots (as stated in the attachment) should be returned to the local supplier.
According to the local supplier, the affected devices were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 July 2012