BEUDAMED
    FDA Enforcement Class II Terminated

    Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

    Recall: Z-1413-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1413-2015
    Event ID
    70839
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2015
    Initiation Date
    March 23, 2015
    Classification Date
    April 10, 2015
    Termination Date
    August 28, 2015
    Address
    1625 W 3rd St Ste 109, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

    Reason

    Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

    Code Info

    Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575

    Distribution

    Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia.

    Quantity

    2620 units