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Tearscience, Inc recalls LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Recalled March 29, 2017 · FDA recall Z-1535-2017 · Tearscience
Hazard
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. · FDA Class II
Units
94,095 units.
Sold at
US (nationwide)
Description
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Product
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Manufacturer(s)
Tearscience, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →