Drug recall
Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260…
FDA recall event 64229 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 64229 |
|---|---|
| Recall numbers | Z-1146-2013 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. |
| Initiation date | Jan 30, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | Mar 10, 2016 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2015691 |
At a glance
- 1–9 Products in this recall
- None 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: