BEUDAMED
    FDA Enforcement Class II Terminated

    Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

    Recall: Z-0785-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0785-2016
    Event ID
    73022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    January 5, 2016
    Classification Date
    February 9, 2016
    Termination Date
    March 25, 2016
    Address
    1625 W 3rd St, N/A, Tempe, AZ, 85281-2438, United States

    Description

    Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

    Reason

    Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

    Code Info

    Product Code: DF6006SC Lot Number: VTZE1782

    Distribution

    Distributed in the states of AL, TX, and CA.

    Quantity

    4 units