Recalls / —
—#115631
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.
- FDA product code
- KRA — Catheter, Continuous Flush
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K896819, K925638
- Affected lot / code info
- 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.
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.
Root cause (FDA determination)
Process change control
Action the firm took
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.
Recalling firm
- Firm
- Edwards Lifesciences, LLC
- Address
- 1 Edwards Way, Irvine, California 92614-5688
Distribution
- 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.
Timeline
- Recall initiated
- 2013-01-30
- Posted by FDA
- 2013-04-18
- Terminated
- 2016-03-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #115631. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.