FDA-Device2017-03-29Class II
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Tearscience, Inc
Hazard
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Sold states
US (nationwide)
Affected count
94,095 units.
Manufactured in
5151 McCrimmon Pkwy Ste 250, Morrisville, NC, United States
Products
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2017Don't want to check this manually?
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