Australian Recall: Medtronic Covidien Shiley Hi/Low-Contour Oral/Nasal Tracheal Tubes Cuffed
Medtronic Australasia has advised that a shipment of Covidien Shiley Hi-Contour and Low-Contour Cuffed Oral/Nasal Tracheal Tubes to Australia may have been contaminated with fungicidal agents in transit.
The potential contamination occurred during fumigation of adjacent cargo by Australian customs authorities. It is not clear whether the fungicide will have penetrated the sterile packaging of the tubes; therefore, Medtronic is recalling all affected lots for testing.
Users are advised to immediately remove from use and quarantine all affected lots. Return the products to Medtronic along with the form that has been distributed to customers. Please also distribute the recall notice to all personnel who may handle affected tubes.
More information is available from the Therapeutic Goods Administration recall notice.