Drug recall
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight…
FDA recall event 62408 · Class II · Gulf Fiberoptics, Inc.
Key facts
| Event ID | 62408 |
|---|---|
| Recall numbers | Z-2029-2012 |
| Recalling firm | Gulf Fiberoptics, Inc. |
| Product type | Devices |
| Products | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. |
| Initiation date | Apr 9, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Mar 7, 2013 |
| City | Oldsmar |
| State | FL |
| Country | United States |
| FEI number | 3003768921 |
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: