Z-1535-2017 Class II Terminated
FDA device recall Z-1535-2017 was initiated by Tearscience, Inc on January 30, 2017 and is designated Class II. Reason for recall: Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. The recall status is terminated (terminated November 27, 2017). Affected quantity: 94,095 units..
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- January 30, 2017
- Termination Date
- November 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,095 units.
Product Description
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Reason for Recall
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Distribution Pattern
US (nationwide)
Code Information
Model number LFD-1000 and LFD-1100, All lots