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

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide and the countries of CA, BE, CL. Quantity: 1,822 units Lot/code info: 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

UPC codes

10381780263906

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.