Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class I Recall
MedSun: Newsletter #87, August 2013

FDA MedWatch Safety Alert

The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually a 3.0mm pediatric tube. Although the neonatal and pediatric tubes have the same inner diameter, the pediatric tube is 4.0mm longer for this particular model.
An oversized tracheostomy tube may cause permanent injury to the trachea.

Additional Information:

Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall. FDA MedWatch Safety Alert. July 22, 2013.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/admin/segment_add.cfm?id=197


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