BEUDAMED
    FDA Enforcement Class II Terminated

    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

    Recall: Z-1082-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1082-2015
    Event ID
    70175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 2, 2015
    Classification Date
    February 10, 2015
    Termination Date
    October 25, 2016
    Address
    2400 Bernville Road, N/A, Reading, PA, 19605, United States

    Description

    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

    Reason

    Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

    Code Info

    product number CDC-42802-P1A, lot number 23F14A0063

    Distribution

    Nationwide

    Quantity

    1195