Z-1535-2017 Class II Terminated
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