BEUDAMED
    FDA Recall Terminated

    (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    Recall: Z-0293-2020 · Initiated October 16, 2018

    Recall

    Recall Number
    Z-0293-2020
    Event Number
    83633
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DRS
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    October 16, 2018
    Terminated
    June 15, 2021
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. 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.

    Action

    The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.

    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