BEUDAMED
    FDA Enforcement Class II Ongoing

    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750

    Recall: Z-2138-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-2138-2024
    Event ID
    94622
    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
    June 19, 2024
    Initiation Date
    May 7, 2024
    Classification Date
    June 12, 2024
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750

    Reason

    Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

    Code Info

    UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569

    Distribution

    Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey

    Quantity

    59 units