Drug recall
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label…
FDA recall event 64395 · Class II · Endogastric Solutions Inc
Key facts
| Event ID | 64395 |
|---|---|
| Recall numbers | Z-1136-2013 |
| Recalling firm | Endogastric Solutions Inc |
| Product type | Devices |
| Products | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. |
| Initiation date | Feb 4, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | Jul 2, 2013 |
| City | Redmond |
| State | WA |
| Country | United States |
| FEI number | 3005473391 |
At a glance
- 1–9 Products in this recall
- 1–9 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: