Tracoe Mini 3.0mm Tracheostomy Tubes, model number 350-3.0, lot number 000-1000071752, have been recalled because the device packaging is mislabeled. 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. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected products were manufactured from December 12, 2012, to January 14, 2013, and distributed from April 9, 2013, to April 12, 2013.
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.
See the FDA Announcement