BEUDAMED
    FDA Enforcement Class II Terminated

    Quanta System Sterile Optical Laser Fiber, reusable

    Recall: Z-1844-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1844-2021
    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, reusable

    Reason

    Product sterility is potentially compromised.

    Code Info

    Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150

    Distribution

    Nationwide distribution via 6 US distributors

    Quantity

    307