Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Recall
- Recall Number
- Z-0029-2022
- Event Number
- 88624
- Firm
- Aesthetics Systems Usa Inc
- FEI Number
- 3006482872
- Product Code
- ITX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 23, 2021
- Address
- 1149 Pomona Rd, Ste J, Corona, CA, 92882-7600
Description
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
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.
On 08/23/2021, recall notices were emailed to customers. Customer were asked to take the following actions: Stop using and discard affected product. If you have further distributed affected product, please notify them at once of this product recall by sharing the recall notification letter. Complete the response form indicating the product and lot numbers identified and the actions taken in the comment section. Customers with questions are encouraged to call the recalling firm at 1-800-332-8763.
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
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