Z-1873-2024 Class II Ongoing
FDA device recall Z-1873-2024 was initiated by Integra LifeSciences Corp. on Apr 17, 2024 and is designated Class II. Reason for recall: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. The recall status is ongoing. Affected quantity: 1,822 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Apr 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,822 units
Product Description
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Reason for Recall
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1873-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026