Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Jagtome RX, Hydratome RX, Dreamtome RX, Cannulating Sphincterotomes, and Jagtome Revolution RX [Multiple Material Number, GTIN, Batch Number and Expiration Date Range].
The manufacturer's internal investigation has determined that the inner pouch for affected product may be damaged and may compromise the sterile barrier. Use of a Sphincterotome from a package with a sterile barrier breach presents a risk of infection. The most serious health risk that could occur is a post-procedure bile duct infection.
The manufacturer advises affected user to identify, segregate and return the affected product.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Dec 2021