Drug recall
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
FDA recall event 80423 · Class II · COVIDIEN MEDTRONIC
Key facts
| Event ID | 80423 |
|---|---|
| Recall numbers | Z-2503-2018, Z-2504-2018, Z-2505-2018, Z-2506-2018, Z-2507-2018, Z-2508-2018, Z-2509-2018, Z-2510-2018, Z-2511-2018, Z-2512-2018, Z-2513-2018, Z-2514-2018 and 2 more |
| Recalling firm | COVIDIEN MEDTRONIC |
| Product type | Devices |
| Products | Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT, Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM, Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM, Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT, Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV and 9 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage… |
| Initiation date | May 22, 2018 |
| Report date | Jul 25, 2018 |
| City | NORTH HAVEN |
| State | CT |
| Country | United States |
| FEI number | 3012474051 |
At a glance
- 10–99 Products in this recall
- None 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: