BEUDAMED
    FDA Enforcement Class II Terminated

    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

    Recall: Z-1943-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1943-2018
    Event ID
    80080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olsen Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    May 11, 2018
    Classification Date
    May 25, 2018
    Termination Date
    April 15, 2019
    Address
    3230 Commerce Center Pl, N/A, Louisville, KY, 40211-1900, United States

    Description

    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

    Reason

    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

    Code Info

    all codes

    Distribution

    Worldwide Distribution

    Quantity

    71,890 devices