BEUDAMED
    FDA Enforcement Class II Terminated

    ArrowClarke" PleuraSeal¿ Thoracentesis Kit

    Recall: Z-1298-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1298-2018
    Event ID
    79294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    October 24, 2017
    Classification Date
    April 3, 2018
    Termination Date
    April 17, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    ArrowClarke" PleuraSeal¿ Thoracentesis Kit

    Reason

    Product packaging may not be completely sealed.

    Code Info

    AK01000 AK-01000-J AK-01000-T ASK-01000-CHP

    Distribution

    Nationally

    Quantity

    N/A