FDA Enforcement
Class II
Ongoing
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Recall: Z-1873-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1873-2024
- Event ID
- 94453
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 29, 2024
- Initiation Date
- April 17, 2024
- Classification Date
- May 20, 2024
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650, United States
Description
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Reason
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Code Info
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
Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Quantity
1,822 units