On April 17, 2013, Bryan Medical, Inc. recalled a single lot of its Tracoe Mini 3.0mm Tracheostomy Tube due to mislabeled packaging. The tube is used “to provide safe airway access and to remove discharge from the lungs… in neonatal and pediatric patients.” The recalled lot consisted of longer pediatric tube mislabeled as shorter neonatal version. Use of an oversized tube in neonatal setting can cause permanent injury or death. The recall of the Tracoe Mini tubes is “Class I” – the most serious type of recall.
According to the FDA Recall Notice, “[t]he 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.”