BEUDAMED
    FDA Recall Terminated

    Quanta System Sterile Optical Laser Fiber, single use

    Recall: Z-1843-2021 · Initiated April 27, 2021

    Recall

    Recall Number
    Z-1843-2021
    Event Number
    87814
    Firm
    Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy
    FEI Number
    3004378299
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 27, 2021
    Terminated
    September 5, 2023

    Description

    Quanta System Sterile Optical Laser Fiber, single use

    Reason

    Product sterility is potentially compromised.

    Action

    The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.

    Distribution

    Nationwide distribution via 6 US distributors

    Quantity

    2427 units