Aesthetics Systems Usa Inc Recall 88624
Description: Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Aesthetics Systems Usa Inc Recall 88624 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0029-2022 |
| Event ID | 88624 |
| Event Description | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA. |
| Quantity | 23 |
| Recall Reason | 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. |
| Device Classification | 20211013 |
| Device Code Info | All lots with valid expiration dates |
| Center Classification Date | 20211006 |
| Recall Initiation Date | 20210823 |
| Recalling Firm | Aesthetics Systems Usa Inc |
| Initial Notification | Letter |
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