Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Reason for recall: Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom. Quantity: 173 units Lot/code info: UDI-DI: 10381780431930 Lot Number/Exp. Date: 6824670 1-Aug-24 7127164 1-Sep-24
10381780431930
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.