BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1413-2015 · Initiated March 23, 2015

    Recall

    Recall Number
    Z-1413-2015
    Event Number
    70839
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 23, 2015
    Posted
    April 10, 2015
    Terminated
    August 28, 2015
    Address
    1625 W 3rd St, Ste 109, Tempe, AZ, 85281-2438

    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.

    Action

    Bard sent an Urgent Medical Device Recall Notification letter dated March 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the product code and lot combination listed on the attachment 1 of the recall letter may be at risk of having deflation related issues. Customers are instructed to complete and return the Effectiveness Check Form. Customers with questions are instructed to call Bard Peripheral Vascular's (BPV) at (800) 321-4254 option #2 Ext 2501 (M-F 7am-4pm MST) Customers are instructed to fax the recall and effectiveness check form to BPV at (800) 994-6772.

    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