BEUDAMED
    FDA Recall Open, Classified

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    Recall: Z-1688-2024 · Initiated March 13, 2024

    Recall

    Recall Number
    Z-1688-2024
    Event Number
    94293
    Firm
    Electro Medical Systems SA Chemin De La Vuarpilliere
    FEI Number
    3002806910
    Product Code
    ELC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 13, 2024
    Posted
    April 24, 2024
    Address
    31 Nyon Switzerland

    Description

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    Reason

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

    Action

    On 3/13/2024, the firm notified, via email, its distributors and asked them to extend the recall to end users. Currently the Customer Notification Letter to end users is being drafted (date of distribution pending). The Customer Notification Letter will information customers that the firm is recalling WATER, CLEANER and PIEZON Bottles due to a manufacturing issue that may result with these affected bottles to leak and/or break and in unfavorable cases may lead to injuries. Customers are instructed to: 1. Cease use of the affected products. 2. Return the affected products to their distributors For questions or assistance, contact EMS Dallas at 1-800-367-0367 or email to [email protected] Monday thru Friday 8:00 a.m. to 5:00 p.m. CST.

    Distribution

    Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.

    Quantity

    54