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U.S. Department of Health and Human Services

Class 2 Device Recall Heartport

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  Class 2 Device Recall Heartport see related information
Date Initiated by Firm April 27, 2006
Date Posted June 09, 2006
Recall Status1 Terminated 3 on December 03, 2008
Recall Number Z-1101-06
Recall Event ID 35335
510(K)Number K990772  
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
Code Information Product Code DFK24 Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043.
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Cindy Crosby
908-218-3365
Manufacturer Reason
for Recall		 During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
FDA Determined
Cause 2		 Other
Action The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.
Quantity in Commerce 368
Distribution There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy.
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 = HEARTPORT, INC.
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