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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula
see related information
Date Posted April 14, 2013
Recall Status1 Open
Recall Number Z-1111-2013
Recall Event ID 64782
Premarket Notification
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, Utah 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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