Recall Z-0029-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
Aesthetics Systems Usa Inc
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
| Date | Aug 23, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 23 |
| Distribution | U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., Feb 21, 1996 |