Class 2 Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula

• Date Initiated by Firm: March 14, 2013
• Date Posted: April 14, 2013
• Recall Status: Terminated on March 08, 2016
• Recall Number: Z-1111-2013
• Recall Event ID: 64782
• 510(K)Number: K123298
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
• Code Information: Model DIIFEMII018A, Lot 59337174
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 12050 Lone Peak Pkwy; Draper UT 84020-9414
• For Additional Information Contact: Suzanne Carpenter; 801-565-6195
• Manufacturer Reason for Recall: Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
• FDA Determined Cause: Packaging process control
• Action: Edwards Lifesciences sent an Urgent Field Safety Notice letter dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of any affected product remaining in inventory and to return any unused devices to Edwards. A completed Acknowledgement Form should be faxed to Edwards at 800-422-9329 within three days of receiving the notice. Questions regarding the recall should be directed to Edwards Customer Services at 800-424-3278, 6:00AM - 4:30PM PST.
• Quantity in Commerce: 379 units
• Distribution: USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
• 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