The FDA has announced a class I recall of certain Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tubes. The affected products (Model: 350-3.0, Lot Number: 000-1000071752) were manufactured by Tracoe Medical Gmbh, a German company, from December 12, 2012, to January 14, 2013, and distributed by Bryan Medical, Inc., an Ohio company, from April 9, 2013, to April 12, 2013.
The outside packaging on these recalled products states that it contains 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 is warning that the recalled Bryan Medical Tacoe Mini may cause serious adverse health consequences, including death.
Bryan Medical recalled this product in April, 2013, yet the recall was not made public until today. Because of this delay, it is possible that some neonatal doctors may not have known about the connection between the mislabeled tracheostomy tube and tracheal injuries. If your baby suffered tracheal injuries, you should contact our lawyers to determine if you have product liability claims against Bryan Medical and Tracoe Medical. A lawsuit against the companies would seek compensation for medical expenses, cost of care, pain, emotional distress, loss of wages (parents), and other lawful damages.