LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model number LFD-1000 and LFD-1100, All lots
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Tearscience, Inc
- Reason for Recall:
- Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Product Codes/Lot Numbers:
Model number LFD-1000 and LFD-1100, All lots
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1535-2017
Related Recalls
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.