BEUDAMED
    FDA Enforcement Class II Terminated

    Manometer, 550 ml three-Way Stopcock; STERILE;

    Recall: Z-1421-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1421-2018
    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

    Manometer, 550 ml three-Way Stopcock; STERILE;

    Reason

    The integrity of the sterile packaging is potentially compromised.

    Code Info

    Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962

    Distribution

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

    Quantity

    4,240 units