Medical device manufacturer, Penlon Ltd., has issued an urgent field safety notice concerning CrystalR Metal Disposable Blade (Mac 3 and Mac 4).
Penlon has been made aware of an incident where Mac 3 blades have been incorrectly packaged in disposable bags labeled as Mac 4 and then packed in a carton stating size Mac 4. The affected batches have been identified and Penlon has determined that this poses a low risk to the users, as users will recognise that the blade is not the size stated on the disposable bag prior to use or during pre-use check.
The manufacturer further advised that all theatre staff and stores personnel should check their stock with expiry dates between August 2010 and August 2015 and ensure that the sizes etched on the blades, inner plastic bags, and the carton all match.
According to Penlon, the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.