Integra LifeSciences Corp. Recall 93356
Description: Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
Integra LifeSciences Corp. Recall 93356 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0491-2024 |
| Event ID | 93356 |
| Event Description | Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND |
| 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 | 1639 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:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-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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