CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

Pressure Monitoring sets with VAMP Plus closed blood sampling system recalled

Edwards Lifesciences is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling system, distributed nationwide in the US. The recall was initiated on 30 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes59184554, 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.

Quantity recalled30,467

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1146-2013
FDA event ID: 64229
Recalling firm: Edwards Lifesciences, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jan 2013
FDA classified: 18 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

30 Jan 2013	Recall initiated by company
18 Apr 2013	Classified by FDA	+78 days
24 Apr 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Florida Hawaii Idaho Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri North Carolina North Dakota New Mexico Nevada New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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