BEUDAMED
    FDA Recall Open, Classified

    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

    Recall: Z-0234-2023 · Initiated October 14, 2022

    Recall

    Recall Number
    Z-0234-2023
    Event Number
    91045
    Firm
    Sonendo Inc
    FEI Number
    3010817521
    Product Code
    ELC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 14, 2022
    Posted
    November 14, 2022
    Address
    26051 Merit Cir, Ste 104, Laguna Hills, CA, 92653-7008

    Description

    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

    Reason

    Procedure Instruments with erroneous unit carton labels.

    Action

    On 10/14/2022, the firm sent an "URGENT PRODUCT ADVISORY NOTICE" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes: a) The GentleWave brand identification; b) The Sonendo brand identification; c) Information such as: "Manufactured by:" and various ISO informational labeling symbols Customers are instructed: -Complete and return (fax or email) the Customer Acknowledgement Letter. -No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error. For questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to [email protected]

    Distribution

    Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

    Quantity

    16 instruments