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U.S. Department of Health and Human Services

Class 2 Device Recall Aortic Perfusion Cannula

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  Class 2 Device Recall Aortic Perfusion Cannula see related information
Date Initiated by Firm April 18, 2006
Date Posted June 09, 2006
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-1092-06
Recall Event ID 35291
510(K)Number K831769  
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm, Edwards Lifesciences
Code Information REF: DARH221190A. Lot number: 58198731
Recalling Firm/
Edwards Lifesciences Research Medical, Inc.
6864 Cottonwood St
Midvale UT 84047-1083
For Additional Information Contact
Manufacturer Reason
for Recall
Due to potential embrittlement of the plastic tip which may crack or separate during use.
FDA Determined
Cause 2
Action Consignees were notified by letter and visit beginning 04/18/2006.
Quantity in Commerce 50 units (Domestic)
Distribution CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
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 = RESEARCH INDUSTRIES CORP.