BEUDAMED
    FDA Enforcement Class II Terminated

    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation

    Recall: Z-2337-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2337-2017
    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

    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation

    Reason

    The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access

    Code Info

    Material number: CDC-24301-1A, CDC-24306-1A Device Listing D025398

    Distribution

    Worldwide Distribution - US (nationwide) and Canada

    Quantity

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