Recall Z-3033-2018 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SPS Sterilization, Inc
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
| Date | Mar 7, 2018 |
| Status | Terminated |
| Reason | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Root cause | Labeling False and Misleading |
| Action | Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same. |
| Quantity | 1 unit total |
| Distribution | US distribution to AZ, CA, FL, OH, PA, TX, VA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140208 | FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII Edwards Lifesciences, LLC, Mar 5, 2014 |