FDA Enforcement
Class II
Ongoing
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Recall: Z-0497-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0497-2024
- Event ID
- 93356
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 13, 2023
- Initiation Date
- October 19, 2023
- Classification Date
- December 6, 2023
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650, United States
Description
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
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 Info
UDI-DI: 10381780263876 Lot Number/Exp. Date: 6844180 1-Dec-23; 7028238 1-Jan-24; 7078247 17-Mar-24 7248995 1-Jun-24
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Quantity
160 units