BEUDAMED
    FDA Recall Open, Classified

    HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

    Recall: Z-1154-2021 · Initiated February 1, 2021

    Recall

    Recall Number
    Z-1154-2021
    Event Number
    87274
    Firm
    Bovie Medical Corporation
    FEI Number
    3007593903
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 1, 2021
    Address
    5115 Ulmerton Rd, Clearwater, FL, 33760-4004

    Description

    HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

    Reason

    There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

    Action

    The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.

    Distribution

    US Nationwide distribution in the states of CA and FL.

    Quantity

    3862 units