BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

    Recall: Z-2335-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2335-2017
    Event ID
    77232
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    May 9, 2017
    Classification Date
    June 12, 2017
    Termination Date
    September 17, 2018
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

    Reason

    Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

    Code Info

    Material number: CDC-11242-1A Device Listing D025760

    Distribution

    Worldwide Distribution - US (nationwide) and Canada

    Quantity

    27,485 units distributed in U.S., 4,371 units distributed internationally