Device product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Z-1873-2024
Product summary
- Event
- Event 94453
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,822 units
- Official record key
device-enforcement:Z-1873-2024
Official wording
Reason: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Code information: UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025
Distribution pattern: Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Derived failure modes
-
Sterility assurance
sterile packaging (header bag) of the Cranial Access Kit may compromise