BEUDAMED
    FDA Recall Terminated

    6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.

    Recall: Z-1633-2008 · Initiated March 17, 2008

    Recall

    Recall Number
    Z-1633-2008
    Event Number
    47361
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 17, 2008
    Posted
    August 13, 2008
    Terminated
    July 7, 2011
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.

    Reason

    Mislabeling: The part number on the product label packaging may not match the product.

    Action

    Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.

    Distribution

    Nationwide Distribution.

    Quantity

    10 units