FDA Device recall Z-1196-2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard by Integra Lifesciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1196-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-19 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | UDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1196-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.