BEUDAMED
    FDA Enforcement Class I Terminated

    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

    Recall: Z-1376-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1376-2019
    Event ID
    82705
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2019
    Initiation Date
    April 26, 2019
    Classification Date
    May 28, 2019
    Termination Date
    September 22, 2020
    Address
    950 Elkton Blvd, N/A, Elkton, MD, 21921-5322, United States

    Description

    Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

    Reason

    There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

    Code Info

    Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17

    Distribution

    The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

    Quantity

    1481