BEUDAMED
    FDA Enforcement Class II Ongoing

    Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

    Recall: Z-2501-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2501-2021
    Event ID
    88520
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    July 8, 2021
    Classification Date
    September 21, 2021
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002, United States

    Description

    Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

    Reason

    As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

    Code Info

    Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

    Distribution

    U.S. Nationwide distribution in the state of WA. O.U.S.: N/A

    Quantity

    20 units