FDA-Device2024-05-29Class II
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Integra LifeSciences Corp.
Hazard
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Sold states
Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Affected count
1,822 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1873-2024Don't want to check this manually?
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