BEUDAMED
    FDA Enforcement Class I Ongoing

    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

    Recall: Z-2167-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2167-2025
    Event ID
    97222
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hamilton Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 26, 2025
    Classification Date
    July 30, 2025
    Address
    Parc Industrial Vial 10, Domat/Ems, N/A, Switzerland

    Description

    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

    Reason

    Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

    Code Info

    UDI-DI: 07630002802963, Lots: 199675, 199676

    Distribution

    US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.

    Quantity

    2,560