BEUDAMED
    FDA Enforcement Class II Terminated

    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.

    Recall: Z-1166-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1166-2018
    Event ID
    79342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    November 14, 2017
    Classification Date
    March 22, 2018
    Termination Date
    July 15, 2019
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.

    Reason

    Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

    Code Info

    CDC-42703-P1A CDC-45703-P1A 13F16H0215 13F16H0216 13F16J0157 13F16J0053 13F16J0182 13F16J0186 13F16K0119 13F16K0266

    Distribution

    Nationwide Distribution

    Quantity

    18,124 total