BEUDAMED
    FDA Recall 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 · Initiated August 13, 2014

    Recall

    Recall Number
    Z-2636-2014
    Event Number
    69049
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 13, 2014
    Posted
    September 12, 2014
    Terminated
    June 30, 2015
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    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.

    Action

    Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.

    Distribution

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

    Quantity

    8251 total devices (3777 US)