Drug recall
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and…
FDA recall event 73183 · Class II · Cordis Corporation
Key facts
| Event ID | 73183 |
|---|---|
| Recall numbers | Z-1174-2016 |
| Recalling firm | Cordis Corporation |
| Product type | Devices |
| Products | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect cannula of the sheath introducer (smaller than intended). |
| Initiation date | Dec 31, 2015 |
| Report date | Mar 23, 2016 |
| Termination date | Aug 25, 2016 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 1016427 |
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: