Device product
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 body (arterial) of a patient during cardiopulmonary bypass procedures.
Z-1371-2015
Product summary
- Event
- Event 70820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5125 units
- Official record key
device-enforcement:Z-1371-2015
Official wording
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.
Code information: Model/Lot Numbers: FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930; FEMII008AT/59807985, 59867050, & 59873263; FEMII008V/59873250 & 59873251; FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934; FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910; FEMII010V/59751074, 59849119 & 59890924; FEMII012A/ 59801792,59867064, 59884766 & 59884778 FEMII012AT/59852940 & 59867051; and FEMII012V/59723307, 59796683, 59849124 & 59873252
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.