FDAJanuary 30, 2017device
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
What to do
FDA enforcement status: Terminated
Brands named
tearscience
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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