Class 2 Device Recall LipiFlow

• Date Initiated by Firm: January 30, 2017
• Date Posted: March 22, 2017
• Recall Status: Terminated on November 27, 2017
• Recall Number: Z-1535-2017
• Recall Event ID: 76365
• 510(K)Number: K112704 K133127 K161357
• Product Classification: Eyelid thermal pulsation system - Product Code ORZ
• Product: LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
• Code Information: Model number LFD-1000 and LFD-1100, All lots
• Recalling Firm/ Manufacturer: Tearscience, Inc; 5151 McCrimmon Pkwy Ste 250; Morrisville NC 27560-5427
• For Additional Information Contact: Stephen Beverrsluis; 919-459-4831
• Manufacturer Reason for Recall: Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
• FDA Determined Cause: Labeling Change Control
• 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.
• Quantity in Commerce: 94,095 units.
• Distribution: US (nationwide)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ORZ