Device product
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Z-0498-2024
Product summary
- Event
- Event 93356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 173 units
- Official record key
device-enforcement:Z-0498-2024
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: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23; 7002983 1-Jan-24
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