ISSUE: 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. This product may cause serious adverse health consequences, including death.
BACKGROUND: The Tracoe Mini 3.0mm Tracheostomy Tube is intended to be placed into a surgical opening of the trachea (windpipe) to provide safe airway access and to remove discharge from the lungs. These devices are indicated for use in neonatal and pediatric patients.
The affected products (Model: 350-3.0, Lot Number: 000-1000071752) were manufactured from December 12, 2012, to January 14, 2013, and distributed from April 9, 2013, to April 12, 2013.
RECOMMENDATION: On April 17, 2013, the firm notified its customers of the problem by telephone and asked them to return affected devices for replacement. For questions about this recall, contact Bryan Medical, Inc. at 513-272-1600.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: