BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

    Recall: Z-1365-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1365-2019
    Event ID
    82506
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    December 13, 2018
    Classification Date
    May 16, 2019
    Termination Date
    October 1, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.

    Reason

    Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

    Code Info

    Lot /Batch Number: 23F18F0005, 23F18B0583 GTN:40801902120753

    Distribution

    US Nationwide Distribution

    Quantity

    963 units (US) in total