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U.S. Department of Health and Human Services

Class 2 Device Recall Aortic Cannula

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 Class 2 Recall
Aortic Cannula
see related information
Date Posted May 13, 2011
Recall Status1 Terminated on May 13, 2011
Recall Number Z-2196-2011
Recall Event ID 57951
Premarket Notification
510(K) Number
K033463 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Code Information Lot Number: 58946275
Recalling Firm/
Manufacturer
Edwards Lifesciences Llc
12050 Lone Peak Parkway
Draper, Utah 84020-9414
Manufacturer Reason
for Recall
Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020. If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time.
Quantity in Commerce 20
Distribution Nationwide distribution: CA only.
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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