Z-1146-2013Class II

Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260...

Name: Z-1146-2013 Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260...
Creator: Edwards Lifesciences, LLC
Published: 2013-01-30
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-01-30 / Terminated

FDA source

Edwards Lifesciences, LLC began a recall of Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3... on 2013-01-30. FDA classified it as Class II and gives the reason as "The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1146-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-30
Posted: 2013-04-18
Terminated: 2016-03-10
Recalling firm: Edwards Lifesciences LLC
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.
Product code: KRA Catheter, Continuous Flush
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 30,467
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code KRA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)