Z-0496-2024 Class II Ongoing
FDA device recall Z-0496-2024 was initiated by Integra LifeSciences Corp. on October 19, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 485 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 485 units
Product Description
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Code Information
UDI-DI: 10381780431916 Lot Number/Exp. Date: 6500469 1-Mar-25 6844175 1-Mar-25 7078238 1-May-25