BEUDAMED
    FDA Enforcement Class II Ongoing

    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

    Recall: Z-1196-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1196-2024
    Event ID
    93881
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    January 19, 2024
    Classification Date
    February 28, 2024
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

    Reason

    A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

    Code Info

    UDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-25 7253136 16-Jul-25 7275711 29-Jul-25 7300837 29-Jun-25

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).

    Quantity

    1324 units