BEUDAMED
    FDA Enforcement Class II Ongoing

    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

    Recall: Z-2239-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2239-2023
    Event ID
    92585
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 2, 2023
    Initiation Date
    June 8, 2023
    Classification Date
    July 27, 2023
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

    Reason

    There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

    Code Info

    Lot: 11481383, UDI: (00)886333217151

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    3.0