Reported Oct 26, 2016 · Terminated
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation…
Tearscience, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tearscience, Inc · 5151 McCrimmon Pkwy Ste 250 · Morrisville, NC · 27560-5427
Is this the product you have?
- 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 the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
- Lot codes and dates
- Lot 201615220020
- Amount recalled
- 1,200 Activators (120 boxes of 10 units)
Where it was sold
Why it was recalled
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
This product could cause temporary or reversible health problems — stop using it.
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