BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

    Recall: Z-0179-2018 · Reported December 6, 2017

    Enforcement

    Recall Number
    Z-0179-2018
    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

    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

    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 Numbers: 23F16M0017

    Distribution

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

    Quantity

    N/A