BEUDAMED
    FDA Enforcement Class II Ongoing

    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

    Recall: Z-1809-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1809-2024
    Event ID
    94389
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 1, 2024
    Classification Date
    May 13, 2024
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

    Reason

    Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.

    Code Info

    All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860

    Distribution

    Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.

    Quantity

    85