BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.

    Recall: Z-2288-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2288-2017
    Event ID
    76937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    March 20, 2017
    Classification Date
    June 6, 2017
    Termination Date
    December 18, 2018
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.

    Reason

    Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

    Code Info

    Material number ASK-04001-DU4S1

    Distribution

    Nationwide Distribution

    Quantity

    unknown-firm reports total devices distributed 43,394