BEUDAMED
    FDA Enforcement Class I Terminated

    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.

    Recall: Z-1641-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1641-2014
    Event ID
    67991
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    April 10, 2014
    Classification Date
    June 11, 2014
    Termination Date
    November 29, 2016
    Address
    10 Bowman Dr, N/A, Keene, NH, 03431-5043, United States

    Description

    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.

    Reason

    One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

    Code Info

    Lot or Serial No: 2553426

    Distribution

    US distribution in the state of North Carolina.

    Quantity

    100 devices