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Edwards Lifesciences, LLC recalls Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXV
Recalled April 24, 2013 · FDA recall Z-1146-2013 · Edwards Lifesciences
Hazard
The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. · FDA Class II
Units
30,467
Sold at
Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI) and Europe.
Description
The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
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.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →