The FDA reports a recall of cuffless pediatric tracheostomy tubes
In its May 2009 Patient Safety News, the FDA reports Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes.
The recall stems from difficulties in inserting the obturator that is used to place the tube in the trachea and problems inserting a suction catheter into the tracheostomy tube, which may require replacing the tube.
In a letter issued January 14, 2009, Covidien originally advised to users was to make sure that the obturator and suction catheter fit properly into the tube before using the device on a patient.
In a letter dated March 6, 2009, however, the company revised its recommendations and instructed users to remove all of the affected products from their inventory and return them for replacement or credit.