BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated August 19, 2019

    Recall

    Recall Number
    Z-1443-2020
    Event Number
    84859
    Firm
    RESPIRATORY THERAPEUTICS GROUP LLC
    FEI Number
    3011285025
    Product Code
    BSY
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    August 19, 2019
    Address
    5670 Wilshire Blvd, Ste 1803, Los Angeles, CA, 90036-5679

    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.

    Action

    On 8/19/19 a recall notice was sent to all affected customers. The letter outlined the recall issue and requested that customers complete the enclosed form for the return of the products (new and used) and the issuance of replacement product or credit.

    Distribution

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

    Quantity

    723 cases (7230 units)