BEUDAMED
    FDA Enforcement Class II Terminated

    VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

    Recall: Z-1178-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1178-2021
    Event ID
    87267
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    January 29, 2021
    Classification Date
    March 5, 2021
    Termination Date
    November 1, 2021
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

    Reason

    Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

    Code Info

    All lots

    Distribution

    US Nationwide distribution.

    Quantity

    1,525 units