Recall Z-1146-2013
Edwards Lifesciences, LLC · initiated January 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
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-determined cause: Process change control
Action taken
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.
Details
- Recall number
- Z-1146-2013
- Initiated
- January 30, 2013
- Posted by FDA
- April 18, 2013
- Terminated
- March 10, 2016
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 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.
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA