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.

Additional Information:

Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. FDA MedWatch Safety Alert. March 10, 2009.
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Shiley

Class 1 Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube. FDA Recall. January 14, 2009.
http://www.fda.gov/cdrh/recalls/recall-011409.html


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