BEUDAMED
    FDA Recall Terminated

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    Recall: Z-1303-2009 · Initiated February 26, 2009

    Recall

    Recall Number
    Z-1303-2009
    Event Number
    51284
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 26, 2009
    Posted
    May 26, 2009
    Terminated
    January 7, 2010
    Address
    1445 Flat Creek Rd, Athens, TX, 75751

    Description

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.

    Reason

    Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.

    Action

    Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.

    Distribution

    Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands.

    Quantity

    45 units