Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits causing the packaging to fail the required packaging integrity testing criteria. Therefore, there is a potential sterility concern for any lots produced with this outer packaging. The outer packaging represents the sterile barrier for the cranial access kits, which are sold as single use, sterile kits. Recall start date: January 31, 2024
RecallTracker