Medical device manufacturer, Applied Medical Resources Corporation, has issued a medical device safety alert concerning its GTK14, Alexis Contained Extraction System [Lot Number: 1399880].
The manufacturer is conducting a voluntary medical device correction for one lot of the GTK14, Alexis Contained Extraction System (CES). The manufacturer has identified that some units of GTK14, Alexis Contained Extraction System (CES) from lot number 1399880, contained an incorrect Instructions for Use (IFU). The units had the Kii Fios First Entry IFU rather than the correct Alexis CES IFU. According to the manufacturer, the inaccuracy does not affect the product functionality or safety.
According to the local supplier, the affected devices are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Aug 2021