Recall Z-1146-2013 ยท KRA Catheter, Continuous Flush
Edwards Lifesciences, LLC
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.
| Date | Apr 18, 2013 (initiated Jan 30, 2013) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |