BEUDAMED
    FDA Recall Terminated

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751

    Recall: Z-0883-2008 · Initiated November 19, 2007

    Recall

    Recall Number
    Z-0883-2008
    Event Number
    45857
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 19, 2007
    Posted
    January 31, 2008
    Terminated
    June 5, 2008
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751

    Reason

    Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.

    Action

    Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.

    Distribution

    Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.

    Quantity

    444