BEUDAMED
    FDA Enforcement Class II Terminated

    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

    Recall: Z-0182-2018 · Reported December 6, 2017

    Enforcement

    Recall Number
    Z-0182-2018
    Event ID
    77589
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    November 28, 2017
    Termination Date
    April 13, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

    Reason

    There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

    Code Info

    Lot/Batch Number: 23F16L0021

    Distribution

    Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

    Quantity

    N/A