BEUDAMED
    FDA Enforcement Class I Ongoing

    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

    Recall: Z-0654-2025 · Reported December 25, 2024

    Enforcement

    Recall Number
    Z-0654-2025
    Event ID
    95753
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Kirwan Surgical Products, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2024
    Initiation Date
    November 14, 2024
    Classification Date
    December 16, 2024
    Address
    180 Enterprise Dr, Marshfield, MA, 02050-2110, United States

    Description

    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

    Reason

    Potential for the outer stainless-steel tube to break or detach.

    Code Info

    Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

    Distribution

    Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.

    Quantity

    80,060 units