BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0134-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0134-2013
    Event ID
    63302
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    July 27, 2012
    Classification Date
    October 25, 2012
    Termination Date
    May 25, 2013
    Address
    3150 Nw 107th Ave, N/A, Miami, FL, 33172, United States

    Description

    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. 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.

    Code Info

    Item Code: AL+60000303 Lot #: 11I27, 12B13

    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

    400