BEUDAMED
    FDA Recall Terminated

    Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

    Recall: Z-1222-2017 · Initiated January 20, 2017

    Recall

    Recall Number
    Z-1222-2017
    Event Number
    76138
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    GBZ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 20, 2017
    Terminated
    November 3, 2020
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

    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)

    Action

    Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).

    Distribution

    Nationwide

    Quantity

    1394 cases (10/case)