BEUDAMED
    FDA Enforcement Class II Terminated

    ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

    Recall: Z-0102-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0102-2023
    Event ID
    90871
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 14, 2022
    Classification Date
    October 19, 2022
    Termination Date
    January 19, 2024
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

    Reason

    Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

    Code Info

    UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    18 devices