BEUDAMED
    FDA Recall Open, Classified

    X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

    Recall: Z-1457-2022 · Initiated June 27, 2022

    Recall

    Recall Number
    Z-1457-2022
    Event Number
    90555
    Firm
    Davol, Inc.
    FEI Number
    1213643
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2022
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    Description

    X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

    Reason

    The device may potentially cause a fire, leading to a safety risk.

    Action

    On June 27, 2022, the firm notified customers of the recall through Urgent Medical Device Recall letters. Customers were instructed to immediately identify and destroy all remaining product in your possession. BD will issue credit to customers who purchased the product from BD. If the customer purchased the product from a Distributor, contact your distributor for further instructions and credit resolution. If you have further questions about this recall, contact the firm: Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: [email protected]

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Chile.

    Quantity

    9420 (9337 in US; 83 OUS)