Z-0301-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- September 25, 2016
- Termination Date
- April 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69 units
Product Description
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Reason for Recall
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Distribution Pattern
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Code Information
All serial numbers