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

Recalled May 29, 2024 · FDA recall Z-1873-2024 · Integra LifeSciences

Hazard

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

Units

1,822 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Integra LifeSciences Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →