FDA-Device2021-10-13Class I
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Aesthetics Systems Usa Inc
Hazard
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.
Sold states
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Affected count
23
Manufactured in
1149 Pomona Rd Ste J, Corona, CA, United States
Products
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2022Don't want to check this manually?
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