Drug recall
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The…
FDA recall event 65173 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 65173 |
|---|---|
| Recall numbers | Z-1542-2013 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used. |
| Initiation date | May 14, 2013 |
| Report date | Jun 19, 2013 |
| Termination date | Oct 14, 2014 |
| 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: