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Pressure Monitoring sets with VAMP Plus closed blood… recallZ-1146-2013 · Edwards Lifesciences, LLC · initiated Jan 30, 2013

Class II Terminated All recalls posted in April 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

The firm initiated a recall in Europe via customer letters starting January 30, 2013 to notify the recall of model number T001691A lot number 59326333. The recall was expanded and a worldwide recall via customer letters was initiated on February 11, 2013. The letter identified the product, problem, and actions to be taken by the customers.

Recall details

Recall number
Z-1146-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 30, 2013
Posted by the FDA
Apr 18, 2013
Recalling firm
Edwards Lifesciences, LLC
Quantity
30,467
Product code
KRA
FDA submissions
K896819, K925638
Distribution
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.

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

40 devices cleared under K896819, K925638 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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