BEUDAMED
    FDA Enforcement Class I Ongoing

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    Recall: Z-1047-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1047-2025
    Event ID
    96094
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    December 26, 2024
    Classification Date
    February 4, 2025
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    Reason

    There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

    Code Info

    Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486.

    Distribution

    Distribution was made to MO. There was no government/military/foreign distribution.

    Quantity

    414 kits