FDA Device recall Z-0499-2024
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain by Integra Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0499-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
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
Identifiers
| code_info | UDI-DI: 10381780178095 Lot Number/Exp. Date: 6926457 31-May-24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0499-2024%22
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