BEUDAMED
    FDA Recall Open, Classified

    Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

    Recall: Z-1814-2025 · Initiated May 1, 2025

    Recall

    Recall Number
    Z-1814-2025
    Event Number
    96801
    Firm
    SunMed Holdings, LLC
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 1, 2025
    Posted
    May 30, 2025
    Address
    2710 Northridge Dr Nw, Ste A, Grand Rapids, MI, 49544-9112

    Description

    Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

    Reason

    Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

    Action

    Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed. If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.

    Distribution

    US Nationwide distribution via Medline.

    Quantity

    11,358