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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 Recall
Femoral Venous Cannula
see related information
Date Posted September 11, 2008
Recall Status1 Terminated on September 16, 2008
Recall Number Z-1894-2008
Recall Event ID 47204
Premarket Notification
510(K) Number
K891576 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - 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/
Manufacturer
Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale, Utah 84047
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
PRODUCTION CONTROLS: 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 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 = RESEARCH MEDICAL, INC.
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