The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Mini 3.0mm Tube, for pediatric use [Reference number: 350-3.0; Lot number: 000-1000071752], manufactured by TRACOE medical GmbH.
According to the FDA, the pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1667-2013&w=07172013&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 July 2013