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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Venous Cannula

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  Class 2 Device Recall Femoral Venous Cannula see related information
Date Initiated by Firm February 25, 2008
Date Posting Updated September 11, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall Number Z-1894-2008
Recall Event ID 47204
510(K)Number K891576  K033464  
Product Classification Cardiopulmonary bypass tubing - Product Code DWF
Product Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing.
Code Information Lot 58458813
Recalling Firm/
Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale UT 84047
For Additional Information Contact
Manufacturer Reason
for Recall
Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
FDA Determined
Cause 2
Process control
Action Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.
Quantity in Commerce 10 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 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 = EDWARDS LIFESCIENCES LLC.
510(K)s with Product Code = DWF and Original Applicant = RESEARCH MEDICAL, INC.