LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
FDA Recall Z-1535-2017 · Posted 2017-03-22
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Recalling FirmTearscience, Inc
Recall StatusTerminated
Product CodeORZ
Date Initiated2017-01-30
Date Terminated2017-11-27
Product Quantity94,095 units.
Reason for Recall
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
US (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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