The FDA slapped its highest-risk label on a recall of Bryan Medical’s trachea opening device for neonatal and pediatric patients, citing a labeling mix-up that might permanently damage children’s windpipes.
The Cincinnati, Ohio-based company’s Tracoe Mini Tube, used to provide safe breathing while removing lung discharge, is being recalled under the FDA’s highest-risk Class I status.
Some of Bryan’s pediatric tubes were sold in boxes labeled for neonatal patients, a serious hazard because the oversized tubes could cause serious trachea damage or death if used in infants.
The FDA’s Class I status is reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
The company called all of its customers and asked them to return the affected products, according to the FDA. The mislabeled products were sold for 3 days in mid-April of this year, according to the recall notice.