BEUDAMED
    FDA Enforcement Class II Terminated

    Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.

    Recall: Z-2636-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2636-2014
    Event ID
    69049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 13, 2014
    Classification Date
    September 12, 2014
    Termination Date
    June 30, 2015
    Address
    2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States

    Description

    Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.

    Reason

    Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

    Code Info

    Part number 91003: All Lots

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.

    Quantity

    8251 total devices (3777 US)