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Recall Observatory FDA recall evidence

Device product

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Z-1873-2024

April 17, 2024

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 94453
Status
Ongoing
Classification
Class II
Quantity
1,822 units
Official record key
device-enforcement:Z-1873-2024

Official wording

Reason: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging (header bag) of the Cranial Access Kit may compromise