FDA recall Z-1873-2024

Integra LifeSciences Corp. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-04-17
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1873-2024