Reported Nov 2, 2016 · Terminated
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional…
Lumenis Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis Limited · 13 Hayetzira St.,Yokneam Ind. Park · Yokneam · N/A
Is this the product you have?
- FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
- Lot codes and dates
- All serial numbers
- Amount recalled
- 69 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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