Lumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions
Lumenis Limited is recalling 69 units of the FemTouch delivery system because the provided cleaning instructions may be ineffective for fully assembled devices, posing a risk of cross-contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential cross-contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Lumenis Limited is recalling 69 units of the FemTouch delivery system, which includes the FemTouch Kit (AC-1007415) and FemTouch Tip (SPSA-20002590). This medical device is used to provide fractional treatments in gynecology. The recall affects all serial numbers of the product.
The recall was initiated because the cleaning instructions provided in the FemTouch Operator's Manual may be ineffective for a fully assembled device. This deficiency creates a potential for cross-contamination. The affected units were distributed worldwide, including in the USA, Italy, Russian Federation, Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Healthcare providers and users of the FemTouch delivery system should stop using the device and contact Lumenis Limited for further instructions on how to proceed with the recall.
The recalled product
- Product
- FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
- Manufacturer
- Lumenis Limited
- Hazard
- Affected units
- 69
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distribution scope not specified by the agency.
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