Medical device manufacturer, Boston Scientific Corporation issued a medical device safety alert concerning Advanix Biliary Stent with NaviFlex RX Delivery System (Catalogue number: 3427, 3421, lot number: 15294885, 15335278 and 15416240).
Boston Scientific discovered a limited number of units were shipped from the China distribution centre without the appropriate Chinese local label. These units are expected to have no clinical significance and no probability of injury. No relevant complaints have been reported to the manufacturer.
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 May 2013