—#134907

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K140208
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Process change control

Action the firm took

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: Cirilo Chaparro, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA#XXX; and transfer this notice to other organizations if the affected devices have been transferred to any another facilities. If you have any questions that have not been answered by this letter, please call Edwards Customer Services at 800.424.3278 from the hours of 6:00AM - 4:30PM PST; Edwards Customer Service at (800) 268-3993 from 8:00AM 4:30PM Eastern Time or contact your Edwards sales representative concerning the recall.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-03-23
Posted by FDA: 2015-04-02
Terminated: 2017-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.