Recall Z-1466-2014 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
| Date | Apr 16, 2014 (initiated Apr 9, 2014) |
| Status | Terminated |
| Reason | Potential for separation of dilator tips. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified via letter on 4/4/14 to return affected products. |
| Quantity | 13,115 |
| Distribution | Nationwide, including foreign, govt/VA/Military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123298 | FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING Edwards Lifesciences, LLC, Mar 15, 2013 |