BEUDAMED
    FDA Enforcement Class II Terminated

    Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    Recall: Z-0295-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0295-2020
    Event ID
    83633
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    October 16, 2018
    Classification Date
    November 5, 2019
    Termination Date
    June 15, 2021
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    Reason

    The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

    Code Info

    Lot numbers 11228251 and 11229805

    Distribution

    Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

    Quantity

    Total number in recall for all products in dist: 49,130 units