Integra LifeSciences Corp. Recall 93356
Description: Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences Corp. Recall 93356 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0493-2024 |
| Event ID | 93356 |
| Event Description | Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom. |
| Quantity | 59 units |
| Recall 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 |
| Device Classification | 20231213 |
| Device Code Info | UDI-DI: 10381780431909 Lot Number/Exp. Date: 6837706 1-Mar-25 |
| Center Classification Date | 20231206 |
| Recall Initiation Date | 20231019 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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