Drug recall
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient…
FDA recall event 68193 · Class II · ConMed Corporation
Key facts
| Event ID | 68193 |
|---|---|
| Recall numbers | Z-1719-2014 |
| Recalling firm | ConMed Corporation |
| Product type | Devices |
| Products | MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. |
| Initiation date | May 8, 2014 |
| Report date | Jun 11, 2014 |
| Termination date | Apr 11, 2017 |
| City | Utica |
| State | NY |
| Country | United States |
| FEI number | 3001451571 |
At a glance
- 1–9 Products in this recall
- 10–99 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: