BEUDAMED
    FDA Enforcement Class II Terminated

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    Recall: Z-2346-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2346-2015
    Event ID
    71510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2015
    Initiation Date
    June 19, 2015
    Classification Date
    August 5, 2015
    Termination Date
    March 21, 2016
    Address
    5 Wentworth Dr, N/A, Hudson, NH, 03051-4929, United States

    Description

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    Reason

    Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

    Code Info

    Lot Number : ME215673 EXp: 2019/09

    Distribution

    AZ, CA, LA. IN, NC, TN, TX, VA

    Quantity

    62 cases (10/cs)=620 units