BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1535-2017 · Initiated January 30, 2017

    Recall

    Recall Number
    Z-1535-2017
    Event Number
    76365
    Firm
    Tearscience, Inc
    FEI Number
    3008169506
    Product Code
    ORZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 30, 2017
    Posted
    March 22, 2017
    Terminated
    November 27, 2017
    Address
    5151 McCrimmon Pkwy, Ste 250, Morrisville, NC, 27560-5427

    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.

    Action

    Tearscience sent an MEDICAL DEVICE LABELING CORRECTION/RECALL letter dated January 30, 2017. .Actions to be Taken by Customer: Within 10 business days of receipt of this letter, please take the following actions: 1) Read the enclosed Summary of Important Labeling Changes for the LipiFlow System. 2) Complete the Acknowledgement and Receipt form at www.TSVerify.pmcprograms.com or return the enclosed completed form by email or mail. 3) If you have stored Activators in an environment that is not temperature controlled (without heat and air conditioning), discontinue use of these Activators and call TearScience Labeling Change Hotline at (844) 872-5658. For any questions regarding this letter, please call (844) 872-5658 Monday through Friday, 8:00AM to 6:00PM, Eastern Time. We want to thank you for being a valuable TearScience partner, and as always would like to thank you for your business, your trust, and your commitment to treating MGD. For further questions please call (919) 459-4831.

    Distribution

    US (nationwide)

    Quantity

    94,095 units.