Aesthetics Systems Usa Inc recalls Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer t…

Recall date

August 23, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0029-2022

FDA classification

Class I

Brand / firm

Aesthetics Systems Usa Inc

Sold / distributed

U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.