Recall Z-1371-2015 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the b
| Date | Apr 2, 2015 (initiated Mar 23, 2015) |
| Status | Terminated |
| Reason | Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula. |
| Root cause | Process change control |
| Action | The firm, Edwards, sent an "URGENT - PRODUCT RECALL - ACTION REQUIRED" letter dated March 23, 2015 via FED EX on March 27, 2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review entire inventory for the lots listed; complete and return attached acknowledgment form via fax to Edwards Customer Service at 800.422.9329. within three days of receipt of this Field Safety Notice; contact Customer Service at 800.422.3278 to obtain an RGA number and replacement product; return affected product to Edwards Lifesciences, Attn: |
| Quantity | 5125 units |
| Distribution | Nationwide Distribution. |
| 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 |