Reported Oct 13, 2021 · Ongoing
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer…
Aesthetics Systems USA Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Aesthetics Systems Usa Inc · 1149 Pomona Rd Ste J · Corona, CA · 92882-7600
Is this the product you have?
- Action De Gala
- FuSion Conductive Gel - Product UsageIntended for use in acoustic coupling of ultrasound transducer to tissue
- Lot codes and dates
- All lots with valid expiration dates
- Amount recalled
- 23
Where it was sold
Why it was recalled
Stop using this product now
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Using this product could cause serious injury, illness or death — stop using it now.
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