BEUDAMED
    FDA Enforcement Class II Terminated

    CoolSeal Generator, REF: CSL-200-50

    Recall: Z-0736-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0736-2022
    Event ID
    89570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bolder Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 25, 2022
    Classification Date
    March 8, 2022
    Termination Date
    May 15, 2024
    Address
    331 S 104th St, Suite 200, Louisville, CO, 80027-9713, United States

    Description

    CoolSeal Generator, REF: CSL-200-50

    Reason

    A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

    Code Info

    Serial Numbers: 00161-170, UDI: 00850346007023

    Distribution

    US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK

    Quantity

    10