LipiFlow Thermal Pulsation System/LipiFlow recalled over fire hazard

Recall date

January 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tearscience, Inc recalls LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

Recall number

Z-1535-2017

FDA classification

Class II

Brand / firm

Tearscience, Inc

Sold / distributed

US (nationwide)

Why it was recalled

Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile