Drug recall
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology…
FDA recall event 79166 · Class II · Covidien LLC
Key facts
| Event ID | 79166 |
|---|---|
| Recall numbers | Z-0908-2018 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device cartridge disengaged during use due to manufacturing error. |
| Initiation date | Sep 15, 2017 |
| Report date | Mar 14, 2018 |
| Termination date | Dec 19, 2018 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
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: