Drug recall
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode) is a smooth electrode…
FDA recall event 89306 · Class II · DIXI MEDICAL USA
Key facts
| Event ID | 89306 |
|---|---|
| Recall numbers | Z-0534-2022, Z-0535-2022, Z-0536-2022, Z-0537-2022, Z-0538-2022, Z-0539-2022, Z-0540-2022, Z-0541-2022, Z-0542-2022 |
| Recalling firm | DIXI MEDICAL USA |
| Product type | Devices |
| Products | The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Initiation date | Dec 9, 2021 |
| Report date | Feb 9, 2022 |
| Termination date | Sep 8, 2023 |
| City | Plymouth |
| State | MI |
| Country | United States |
| FEI number | 3014527920 |
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: