FDA Device recall Z-1203-2024
Ref No: INSHITHRZN / Integra Cranial Access Kit
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Ref No: INSHITHRZN / Integra Cranial Access Kit 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-1203-2024 |
| 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: INSHITHRZN / Integra Cranial Access Kit. 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: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 678860…UDI: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 6788605 1-Jan-24 6788606 1-Jan-24 6896388 17-Mar-24 6896389 1-Dec-23 6955158 17-Mar-24 6955159 17-Mar-24 7000265 17-Mar-24 7000266 17-Mar-24 7028235 17-Mar-24 7073054 17-Mar-24 7073055 1-Apr-24 7124709 1-Apr-24 7124710 1-Apr-24 7249011 1-Apr-24 7253162 1-Jun-24 7257042 1-Jun-24 7257043 1-Jun-24 7264841 1-Jun-24 |
|---|
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-1203-2024%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.