LipiFlow Thermal Pulsation System/LipiFlow recall: Labeling Error
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Why was LipiFlow Thermal Pulsation System/LipiFlow recalled?
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number LFD-1000 and LFD-1100, All lots
- Product
- LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- Recalling firm
- Tearscience, Inc
- Quantity
- 94,095 units.
- Distribution
- US (nationwide)
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)