BEUDAMED
    FDA Enforcement Class I Ongoing

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    Recall: Z-0004-2025 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-0004-2025
    Event ID
    95303
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mercury Enterprises, Inc. dba Mercury Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 9, 2024
    Initiation Date
    August 30, 2024
    Classification Date
    October 2, 2024
    Address
    11300 49th St N, N/A, Clearwater, FL, 33762-4807, United States

    Description

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    Reason

    Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

    Code Info

    Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

    Distribution

    US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

    Quantity

    1,300 units