BEUDAMED
    FDA Enforcement Class II Terminated

    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.

    Recall: Z-1158-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1158-2018
    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

    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction 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

    ASK-09903-ECL 23F16H0387 23F16H0595

    Distribution

    Nationwide Distribution

    Quantity

    18,124 total