BEUDAMED
    FDA Recall Terminated

    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

    Recall: Z-0135-2013 · Initiated July 27, 2012

    Recall

    Recall Number
    Z-0135-2013
    Event Number
    63302
    Firm
    Nipro Medical Corporation
    FEI Number
    1000132332
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    July 27, 2012
    Posted
    October 25, 2012
    Terminated
    May 25, 2013
    Address
    3150 Nw 107th Ave, Miami, FL, 33172

    Description

    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

    Reason

    Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.

    Action

    Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.

    Distribution

    Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil.

    Quantity

    1500