Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Covidien DAR airway products [Multiple item codes and lot numbers].
The manufacturer was notified by its supplier of sterilisation services, Steril Milano, of potential deviations from validated parameters for ethylene oxide sterilisation. The deviations affect certain production lots of products which occurred between March 2018 and February 2021 – please refer to the customer letter from the manufacturer for full details.
The manufacturer is advising users to identify, quarantine and discontinue use of the affected products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 April 2021