BEUDAMED
    FDA Enforcement Class II Ongoing

    Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

    Recall: Z-0491-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0491-2024
    Event ID
    93356
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 13, 2023
    Initiation Date
    October 19, 2023
    Classification Date
    December 6, 2023
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

    Reason

    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

    Code Info

    UDI-DI:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.

    Quantity

    1639 units