BEUDAMED
    FDA Enforcement Class II Terminated

    Quanta System Sterile Optical Laser Fiber, single use

    Recall: Z-1843-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1843-2021
    Event ID
    87814
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quanta System, S.p.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    April 27, 2021
    Classification Date
    June 9, 2021
    Termination Date
    September 5, 2023
    Address
    Via Acquedotto 109, N/A, Samarate, N/A, N/A, Italy

    Description

    Quanta System Sterile Optical Laser Fiber, single use

    Reason

    Product sterility is potentially compromised.

    Code Info

    Product Part Numbers: OAF002011 - lots A194207, A194208, A194528, A194529, A201001, A201002 OAF005511 - lots A184635, A192114, A193613, A194527, A202027 OAF006001 - lots A183626 and A193106 OAF008001 - lot A193616 OAF009901 - lot A192911 and A193108 OAF009911 - lots A192914 and A202028 OAF302711 - lot A202029 OAF402011 - lots A380350, A384633, A392907 OAF702711 - lots A190301, A192113, A192906, A193110, A193111, A193112, A194108, A194211, A194532 OAF703611 - lots A180300, A190302, A190303, A192115, A192908, A193102, A193113, A194209, A194210, A195013, A195014

    Distribution

    Nationwide distribution via 6 US distributors

    Quantity

    2427 units