Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1146-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 30, 2013

Date Posted: April 24, 2013

Recall Number: Z-1146-2013

Event ID: 64229

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.

Status: Terminated

Product Quantity: 30,467

Code Information:

59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041, 59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated