Pressure Monitoring sets with VAMP Plus closed blood sampling system… — Class II medical device recall Z-1146-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-04-24, distributed nationwide. The device is being recalled because the firm has received multiple complaints related to incorrect assembly t
| Recall number | Z-1146-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2013-01-30 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2016-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 30,467 |
| Model numbers | PXVP0566, PXVP0826, PXVP0827, PXVP2260, PXVP2284AT3, PXVP23X3AT3, T001691A, T001762A, T100605B, T391T00A, T398807D, VP2 |
Product
Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1146-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.