BEUDAMED
    FDA Recall Terminated

    Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.

    Recall: Z-0737-2016 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-0737-2016
    Event Number
    72945
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    DTK
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 13, 2015
    Posted
    February 1, 2016
    Terminated
    February 1, 2016
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.

    Reason

    IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.

    Action

    The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada

    Distribution

    Distributed to CA only.

    Quantity

    1,183 units