Class II

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

Integra LifeSciences Corp. · April 17, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

1,822 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1873-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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