Integra LifeSciences Corp. Recall 94453
Description: Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Integra LifeSciences Corp. Recall 94453 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1873-2024 |
| Event ID | 94453 |
| Event Description | Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of CA, BE, CL. |
| Quantity | 1,822 units |
| Recall Reason | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. |
| Device Classification | 20240529 |
| 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 |
| Center Classification Date | 20240520 |
| Recall Initiation Date | 20240417 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Letter |
| Similar To |