BEUDAMED
    FDA Enforcement Class II Terminated

    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

    Recall: Z-1153-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1153-2018
    Event ID
    79398
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    February 8, 2018
    Classification Date
    March 21, 2018
    Termination Date
    September 17, 2020
    Address
    5115 Ulmerton Rd, N/A, Clearwater, FL, 33760-4004, United States

    Description

    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

    Reason

    Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

    Code Info

    All lots manufactured since 01/01/2014

    Distribution

    worldwide

    Quantity

    1005 units