Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.
MedSun: Newsletter #35, April 2009
FDA MedWatch Safety Alert
FDA notified healthcare professionals of a Class 1 Recall of specific lots due to complaints received about difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator), and/or a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced.
Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. FDA MedWatch Safety Alert. March 10, 2009.
Class 1 Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube. FDA Recall. January 14, 2009.