BEUDAMED
    FDA Recall Terminated

    CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    Recall: Z-1738-2010 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-1738-2010
    Event Number
    55234
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 29, 2010
    Posted
    June 2, 2010
    Terminated
    July 29, 2010
    Address
    1445 Flat Creek Rd, Athens, TX, 75751

    Description

    CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    Reason

    There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

    Action

    Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.

    Distribution

    Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.

    Quantity

    10 kits