Drug recall
Neoprobe GDS Control Unit, Model Number NPCU3
FDA recall event 86228 · Class III · Devicor Medical Products Inc
Key facts
| Event ID | 86228 |
|---|---|
| Recall numbers | Z-0070-2021 |
| Recalling firm | Devicor Medical Products Inc |
| Product type | Devices |
| Products | Neoprobe GDS Control Unit, Model Number NPCU3 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is… |
| Initiation date | Sep 7, 2020 |
| Report date | Oct 14, 2020 |
| Termination date | May 9, 2023 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 3008492462 |
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: