Device product
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Z-0496-2024
Product summary
- Event
- Event 93356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 485 units
- Official record key
device-enforcement:Z-0496-2024
Official wording
Reason: 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
Code information: UDI-DI: 10381780431916 Lot Number/Exp. Date: 6500469 1-Mar-25 6844175 1-Mar-25 7078238 1-May-25
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Derived failure modes
-
Unknown
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