BEUDAMED
    FDA Enforcement Class II Terminated

    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

    Recall: Z-1535-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1535-2017
    Event ID
    76365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tearscience, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    January 30, 2017
    Classification Date
    March 22, 2017
    Termination Date
    November 27, 2017
    Address
    5151 McCrimmon Pkwy Ste 250, Morrisville, NC, 27560-5427, United States

    Description

    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

    Reason

    Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.

    Code Info

    Model number LFD-1000 and LFD-1100, All lots

    Distribution

    US (nationwide)

    Quantity

    94,095 units.