Medical Device Safety Alert: Boston Scientific RIGIFLEX II Single Use Achalasia Balloon Dilator
Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning RIGIFLEX II Single Use Achalasia Balloon Dilator with:
Boston Scientific has become aware that the pouch label expiration date on a single lot/batch of RIGIFLEX II Single Use Achalasia Balloon Dilators is labeled with the incorrect expiration date, 0213-12. Boston Scientific has confirmed that the correct expiration date is 2013-12 (in the year-month format, YYYY-MM). The product is not expired and there is no patient risk related to the labeling issue if the product is used prior to 2013-12.
The manufacturer advises users to immediately discontinue use of and segregate affected products, and to return the affected product.
According to the local supplier, affected products were not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 31 May 2013