BEUDAMED
    FDA Enforcement Class II Terminated

    Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

    Recall: Z-1426-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1426-2018
    Event ID
    76620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 23, 2017
    Classification Date
    April 18, 2018
    Termination Date
    July 9, 2019
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

    Reason

    The integrity of the sterile packaging is potentially compromised.

    Code Info

    Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185

    Distribution

    Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

    Quantity

    1200 units