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U.S. Department of Health and Human Services

Safety

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Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.

Audience: Emergency room healthcare professionals, pediatricians, hospital risk managers, EMTs

[Posted 03/10/2009] 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.

[March 09, 2009 - Recall Notice - FDA]