BEUDAMED
    FDA Enforcement Class I Terminated

    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

    Recall: Z-1375-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1375-2019
    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

    SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

    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:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09

    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

    1431