BEUDAMED
    FDA Enforcement Class II Terminated

    1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

    Recall: Z-2329-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2329-2017
    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

    1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

    Reason

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

    Code Info

    Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

    Distribution

    Worldwide Distribution - US (nationwide) and Canada

    Quantity

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