FDA ALERT

 

March 10, 2009

Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.: Class 1 Recall of specific lots

FDA notified healthcare professionals of a Class 1 Recall of specific lots due to complaints received about difficulty inserting: 1) the device used to place the tracheostomy tube into the windpipe (obturator), and/or 2) a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced. Healthcare professionals and hospitals should remove all remaining affected products from their inventory, and return them for replacement or credit.

Read the MedWatch safety summary, including a link to the Recall Notice, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Shiley