Recall Z-1146-2013— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2013-01-30, terminated 2016-03-10. It names 2 FDA 510(k) clearances: K925638, K896819. 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: The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-30
- Terminated
- 2016-03-10
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K925638 — PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
- K896819 — VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.