BEUDAMED
    FDA Enforcement Class II Ongoing

    RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

    Recall: Z-1443-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1443-2020
    Event ID
    84859
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RESPIRATORY THERAPEUTICS GROUP LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 11, 2020
    Initiation Date
    August 19, 2019
    Classification Date
    March 5, 2020
    Address
    5670 Wilshire Blvd Ste 1803, N/A, Los Angeles, CA, 90036-5679, United States

    Description

    RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

    Reason

    It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

    Code Info

    Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019

    Distribution

    US Nationwide distribution in the states of CA, NJ, NY. OUS: None

    Quantity

    723 cases (7230 units)