Drug recall
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement…
FDA recall event 72046 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 72046 |
|---|---|
| Recall numbers | Z-2780-2015 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot. |
| Initiation date | Aug 26, 2015 |
| Report date | Sep 30, 2015 |
| Termination date | Feb 10, 2017 |
| 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: