Device product
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Z-1535-2017
Product summary
- Firm
- Tearscience, Inc
- Event
- Event 76365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,095 units.
- Official record key
device-enforcement:Z-1535-2017
Official wording
Reason: Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Code information: Model number LFD-1000 and LFD-1100, All lots
Distribution pattern: US (nationwide)
Derived failure modes
-
Unknown
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.