BEUDAMED
    FDA Enforcement Class II Ongoing

    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

    Recall: Z-0103-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0103-2023
    Event ID
    90870
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BALT USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 7, 2022
    Classification Date
    October 20, 2022
    Address
    29 Parker Ste 100, N/A, Irvine, CA, 92618-1667, United States

    Description

    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

    Reason

    Product pouch label does not match up with carton label

    Code Info

    Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.

    Quantity

    41 impacted devices