Drug recall
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA recall event 80327 · Class II · Megadyne Medical Products, Inc.
Key facts
| Event ID | 80327 |
|---|---|
| Recall numbers | Z-2792-2018 |
| Recalling firm | Megadyne Medical Products, Inc. |
| Product type | Devices |
| Products | MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient. |
| Initiation date | May 15, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Jan 30, 2024 |
| City | Draper |
| State | UT |
| Country | United States |
| FEI number | 1721194 |
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: