Drug recall
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound…
FDA recall event 88624 · Class I · Aesthetics Systems Usa Inc
Key facts
| Event ID | 88624 |
|---|---|
| Recall numbers | Z-0029-2022 |
| Recalling firm | Aesthetics Systems Usa Inc |
| Product type | Devices |
| Products | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 23, 2021 |
| Report date | Oct 13, 2021 |
| City | Corona |
| State | CA |
| Country | United States |
| FEI number | 3006482872 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: