BEUDAMED
    FDA Enforcement Class II Terminated

    Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

    Recall: Z-1221-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1221-2017
    Event ID
    76138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    January 20, 2017
    Classification Date
    February 16, 2017
    Termination Date
    November 3, 2020
    Address
    5 Wentworth Dr, N/A, Hudson, NH, 03051-4929, United States

    Description

    Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

    Reason

    Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

    Code Info

    All Lot Numbers With Expiration Date Prior To December 2019

    Distribution

    Nationwide

    Quantity

    660 cases (10/case)