BEUDAMED
    FDA Enforcement Class II Terminated

    Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616

    Recall: Z-0818-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0818-2022
    Event ID
    89618
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2022
    Initiation Date
    January 21, 2022
    Classification Date
    March 22, 2022
    Termination Date
    March 19, 2024
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616

    Reason

    Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

    Code Info

    Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382

    Distribution

    Worldwide distribution - US Nationwide and the country of Hong Kong.

    Quantity

    1160 kits