Home / Recalls / Medical Devices
Lumenis Limited recalls FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional
Recalled November 2, 2016 · FDA recall Z-0301-2017 · Lumenis
Hazard
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. · FDA Class II
Units
69 units
Sold at
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Description
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.
Product
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Manufacturer(s)
Lumenis Limited
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →