FDASeptember 13, 2016device
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
What to do
FDA enforcement status: Terminated
Brands named
tearscience
UPCs
201615220020
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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