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U.S. Department of Health and Human Services

Class 2 Device Recall FemFlex II Pediatric Femoral Arterial Cannula

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  Class 2 Device Recall FemFlex II Pediatric Femoral Arterial Cannula see related information
Date Initiated by Firm March 23, 2015
Date Posted April 02, 2015
Recall Status1 Terminated 3 on April 17, 2017
Recall Number Z-1371-2015
Recall Event ID 70820
510(K)Number K140208  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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.
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
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Sherri L. Robbins
801-553-7531
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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: 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.
Quantity in Commerce 5125 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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