Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning certain lots of Soloist™ Single Needle Electrode.
According to Boston Scientific, an internal review showed that certain lots of the products were labeled with incorrect expiration dates, in which the expiration date labeled on the electrode (20 years) and the outer box (5 years) was greater than the acceptable 3 year expiration date. No injury is reasonably expected because all affected lots of the product are still within the 3 year expiration date. The manufacturer advised to immediately discontinue use of the affected products.
According to the local supplier, the affected products have not been distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.