Drug recall
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial…
FDA recall event 65744 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 65744 |
|---|---|
| Recall numbers | Z-1972-2013 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude… |
| Initiation date | Jul 16, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Nov 30, 2016 |
| City | Draper |
| State | UT |
| Country | United States |
| FEI number | 1713910 |
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: