BEUDAMED
    FDA Recall Open, Classified

    Mojo 2 Full Face Non Vented Mask, All Sizes

    Recall: Z-1354-2024 · Initiated March 1, 2024

    Recall

    Recall Number
    Z-1354-2024
    Event Number
    94169
    Firm
    SleepNet Corporation
    FEI Number
    1222088
    Product Code
    BZD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 1, 2024
    Posted
    April 1, 2024
    Address
    5 Merrill Industrial Dr, Hampton, NH, 03842-1980

    Description

    Mojo 2 Full Face Non Vented Mask, All Sizes

    Reason

    Update to contraindications and warning language due to CPAP masks containing magnets.

    Action

    The firm emailed consignees a notification titled URGENT: MEDICAL DEVICE RECALL, dated 3/1/24. Consignees were instructed to stop using recalled masks if the user or anyone in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets and contact their mask provider for a replacement mask that does not contain magnets. Consignees that do not have an active medical implant or metallic implant that will interact with magnets do not have to cease use. If a consignee is unsure whether or not to cease use, they should consult with their physician or manufacturer of the implant. Consignees are to continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. Consignees with any questions are to contact Himabindu Koppusetty via email at [email protected] or by phone at 1-800-742-3646x6611 from Monday through from, 8:00 AM to 4:00 PM.

    Distribution

    Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ, IRELAND, ISRAEL, ISREAL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SULTANATE OF OMAN, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.

    Quantity

    2,107 units