BEUDAMED
    FDA Enforcement Class II Terminated

    CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C

    Recall: Z-0049-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0049-2020
    Event ID
    82970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    May 2, 2019
    Classification Date
    October 7, 2019
    Termination Date
    November 30, 2021
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C

    Reason

    After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

    Code Info

    Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228

    Distribution

    Nationwide Foreign: Canada

    Quantity

    115,200