Integra LifeSciences Corp. Recall 93881
Description: Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences Corp. Recall 93881 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1196-2024 |
| Event ID | 93881 |
| Event Description | Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the). |
| Quantity | 1324 units |
| Recall Reason | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| Device Classification | 20240306 |
| Device Code Info | UDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-25 7253136 16-Jul-25 7275711 29-Jul-25 7300837 29-Jun-25 |
| Center Classification Date | 20240228 |
| Recall Initiation Date | 20240119 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Letter |
| Similar To |