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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 Posted September 11, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall Number Z-1893-2008
Recall Event ID 47204
510(K)Number K891576  K033464  
Product Classification Cardiopulmonary bypass tubing - Product Code DWF
Product Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
Code Information Lot 58458668
Recalling Firm/
Manufacturer		 Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale UT 84047
For Additional Information Contact
801-565-6173
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 25 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.
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