Home / Recalls / Medical Devices
Integra LifeSciences Corp. recalls Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Recalled December 13, 2023 · FDA recall Z-0496-2024 · Integra LifeSciences
Hazard
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device · FDA Class II
Units
485 units
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Description
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Product
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →