|TO:||DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel|
|FROM:||David Carlow, DDS Director of Health Services and Daniel A. Micari, Director, Quality Management Services|
|DATE:||March 13, 2009|
MEDICAL DEVICE RECALL ADVISORY: Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.: Class 1 Recall of specific lots
Medical Device Recall Advisory
The FDA Safety Information and Adverse Event Reporting Program (MedWatch) 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:
Please ensure those responsible are aware of this medication advisory. Per the direction of the DDS Director of Health Services all agencies (public and private) should forward this information to their nursing staff. Any questions regarding this medication advisory should be directed to David Carlow, DDS Director of Health Services at (860) 418-6083.