Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Reported: October 13, 2021 Initiated: August 23, 2021 #Z-0029-2022
Product Description
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Reason for Recall
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.
Details
- Recalling Firm
- Aesthetics Systems Usa Inc
- Units Affected
- 23
- Distribution
- U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.. Recalled by Aesthetics Systems Usa Inc. Units affected: 23.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Critical. Recall number: Z-0029-2022.
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