Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning RunWay Guide Catheter with catalogue no.: 38969-664
and lot no.: 2013040058. The expiry date of the affected product is April 2016.
The manufacturer is initiating a product recall as the sterile pouch of the affected devices may not be completely sealed and sterility may be compromised. To date, the manufacturer has received one complaint for this issue.
The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
According to the local supplier, the affected lot was not distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 March 2014