FDA Device recall Z-1873-2024
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure by Integra Lifesciences, citing potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1873-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-17 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Reason
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Identifiers
| code_info | UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 731213…UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025 |
|---|
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-1873-2024%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.