Medical device manufacturer and distributor, Boston Scientific Corporation, has issued a notification of market withdrawal concerning the Extender Cables for Autolith Touch Bipolar Electrohydraulic Lithotripter (EHL). The affected products are identified as follow:

• Extender Cable Universal Product Number (UPN) : M00546750
• Extender Cable Global Trade Item numbers (GTIN) : 00817183020455
• Affected Lot Numbers: 13400, 13401

Boston Scientific, a distributor of the Autolith Touch Bipolar EHL Generators and Extender Cables, is notifying the customers that the manufacturer, Northgate Technologies, Inc., is initiating a voluntary market withdrawal of mislabeled extender cables that were packaged with certain generators.

According to Boston Scientific, the flag label on these cables did not include the Unique Device Identification number required by the United States Food and Drug Administration. The labeling issue has no impact on product performance and there is no risk to patient safety.

The market withdrawal does not include Autolith Touch Bipolar EHL Extender Cables that were sold individually and affects only two extender cable lot numbers mentioned above. No other lot numbers are impacted by the notification.

The affected customers are instructed to verify the UPN and serial number on their generator(s) and the lot number of their extender cable(s). The generator is not impacted and should not be returned or replaced.

Product (i.e. extender cable) replacement is on-going.

According to the local supplier, the affected products are not distributed in Hong Kong

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 06 March 2019