Recall Z-1535-2017 ยท ORZ Eyelid Thermal Pulsation System
Tearscience, Inc
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
| Date | Mar 22, 2017 (initiated Jan 30, 2017) |
| Status | Terminated |
| Reason | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. |
| Root 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 the |
| Quantity | 94,095 units. |
| Distribution | US (nationwide) |
| FDA record | Open on fda.gov |