BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1154-2021
    Event ID
    87274
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    February 1, 2021
    Classification Date
    February 26, 2021
    Address
    5115 Ulmerton Rd, Clearwater, FL, 33760-4004, United States

    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.

    Code Info

    Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).

    Distribution

    US Nationwide distribution in the states of CA and FL.

    Quantity

    3862 units