Drug recall
HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external…
FDA recall event 84305 · Class II · Bio-Signal Group Corp.
Key facts
| Event ID | 84305 |
|---|---|
| Recall numbers | Z-0704-2020, Z-0705-2020 |
| Recalling firm | Bio-Signal Group Corp. |
| Product type | Devices |
| Products | HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to…, HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| Initiation date | Oct 29, 2019 |
| Report date | Dec 25, 2019 |
| Termination date | Sep 7, 2021 |
| City | Acton |
| State | MA |
| Country | United States |
| FEI number | 3006315274 |
At a glance
- 1–9 Products in this recall
- 1–9 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: