BEUDAMED
    FDA Enforcement Class II Terminated

    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    Recall: Z-2647-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2647-2016
    Event ID
    74790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 18, 2016
    Classification Date
    August 24, 2016
    Termination Date
    December 14, 2016
    Address
    5115 Ulmerton Rd, Clearwater, FL, 33760-4004, United States

    Description

    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    Reason

    The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.

    Code Info

    Lot 0316D and 0516B.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.

    Quantity

    95