Beaver-Visitec International Mini Blades

BVI identified a potential seal integrity issue affecting certain units of the products listed in this Voluntary Medical Device Recall notice. The issue may result in an "open seal" condition, in which sterility cannot be guaranteed. the condition has been confirmed through physical investigation, including visual inspection and dye penetration testing. Based on the investigation and sampling performed to date, the condition is intermittent and does not affect all units within the affected lots.