Reported Mar 29, 2017 · Terminated
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
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/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- Lot codes and dates
- Model number LFD-1000 and LFD-1100, All lots
- Amount recalled
- 94,095 units.
Where it was sold
- 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Tearscience, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.