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U.S. Department of Health and Human Services

Class 2 Device Recall Duraflo coated FemFlex Arterial Cannula

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  Class 2 Device Recall Duraflo coated FemFlex Arterial Cannula see related information
Date Initiated by Firm August 26, 2013
Date Posted November 01, 2013
Recall Status1 Open3, Classified
Recall Number Z-0134-2014
Recall Event ID 66112
510(K)Number K123370  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only,

Product Usage:
Edwards Lifesciences femoral access 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. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Code Information Lot number 59388992 expiry 1/1/16
Recalling Firm/
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Suzanne Carpenter
Manufacturer Reason
for Recall
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
FDA Determined
Cause 2
Process control
Action Edwards sent an Urgent Field Safety Notice Product Recall letter dated August 26, 2013 to all affected customer, via Fed-Ex. The product is sold directly to hospitals and distributors. The distributors involved will communicate with their customers directly. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their entire inventory, quarantine and return the affected products. An acknowledgement form is included for completion to assist in the assessment of the inventory. For questions contact Edwards Customer Service at 800-424-3278.
Quantity in Commerce 80 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.