FDA Device recall Z-1201-2024
Ref No: INSHITH / 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: INSHITH / 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-1201-2024 |
| 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: INSHITH / 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: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 67…UDI: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 6788598 1-Sep-23 6788599 1-Dec-23 6788600 1-Jan-24 6896383 1-Dec-23 6896384 1-Jan-24 6896385 1-Jan-24 6955153 17-Mar-24 6955154 17-Mar-24 6955155 17-Mar-24 7000260 17-Mar-24 7000261 17-Mar-24 7000262 17-Mar-24 7028225 17-Mar-24 7028226 17-Mar-24 7028227 1-Apr-24 7073035 1-Apr-24 7073036 1-Apr-24 7073037 1-Apr-24 7124699 1-Apr-24 7124700 1-Apr-24 7124702 1-Apr-24 7249008 1-Jun-24 7249009 1-Jun-24 7257038 1-Jun-24 7257039 1-Jun-24 7257040 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-1201-2024%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.