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Aesthetics Systems Usa Inc recalls Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to
Recalled October 13, 2021 · FDA recall Z-0029-2022 · Aesthetics Systems Usa
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. · FDA Class I
Units
23
Sold at
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Description
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.
Product
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Manufacturer(s)
Aesthetics Systems Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →