Drug recall
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency…
FDA recall event 74553 · Class II · Halyard Health, Inc
Key facts
| Event ID | 74553 |
|---|---|
| Recall numbers | Z-2391-2016 |
| Recalling firm | Halyard Health, Inc |
| Product type | Devices |
| Products | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mismatch between the length of the RF electrode (probe) and the cannula (introducer), |
| Initiation date | Jun 16, 2016 |
| Report date | Aug 17, 2016 |
| Termination date | Sep 8, 2016 |
| City | Alpharetta |
| State | GA |
| Country | United States |
| FEI number | 3011270181 |
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: