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FDA Slaps Ohio-Based Bryan Medical With Its Highest-Risk Recall


7/25/2013 7:48:04 AM

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Ohio-based airway management company Bryan Medical gets the FDA's highest-risk Class I recall for a mislabeling issue among its pediatric trachea tubes. 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.

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