BEUDAMED
    FDA Enforcement Class II Terminated

    Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

    Recall: Z-1869-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1869-2017
    Event ID
    76446
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elcam Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    February 2, 2017
    Classification Date
    April 19, 2017
    Termination Date
    June 8, 2018
    Address
    2 University Plz Ste 620, N/A, Hackensack, NJ, 07601-6224, United States

    Description

    Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

    Reason

    The stopcock was found to have punctures.

    Code Info

    Lot #1670350901

    Distribution

    U.S Nationwide Distribution

    Quantity

    810