BEUDAMED
    FDA Enforcement Class I Ongoing

    CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

    Recall: Z-0548-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0548-2024
    Event ID
    93084
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    October 5, 2023
    Classification Date
    December 14, 2023
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

    Reason

    Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

    Code Info

    UDI-DI 10381780520665 All lots distributed

    Distribution

    US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.

    Quantity

    4941