Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning ALAIR Bronchial Thermoplasty Catheter with:
According to Boston Scientific, it has discovered an inconsistent "Use By" expiration date on a single lot/batch of ALAIR Bronchial Thermoplasty Catheters. The expiration date is listed in two locations on the packaging of the product; the outer box label and the inner tray label. The expiration date on the outer box label, 2014-04, is correct. However, the expiration date on the inner tray, 2012-04, is incorrect. The actual product expiration date is 2 years beyond the incorrect date on the inner tray label. There is no patient risk related to the incorrect date on the inner tray label since the product is not actually expired.
The manufacturer advises users that they can continue to use the device until the expiration date on the outer box label, 20 14-04.
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