Recall Z-1893-2008 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Research Medical, Inc.
Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
| Date | Sep 11, 2008 (initiated Feb 25, 2008) |
| Status | Terminated |
| Reason | Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury. |
| Root cause | Process control |
| Action | Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product. |
| Quantity | 25 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |