BEUDAMED
    FDA Enforcement Class II Terminated

    Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    Recall: Z-0296-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0296-2020
    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 AHD Luer Lock Cap, REF 501303, 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 11228902 and 11230445

    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