Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Venous Cannula

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Femoral Venous Cannulasee related information
Date Initiated by FirmFebruary 25, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall NumberZ-1893-2008
Recall Event ID 47204
510(K)NumberK033464 K891576 
Product Classification Cardiopulmonary bypass tubing - Product Code DWF
ProductEdwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
Code Information Lot 58458668
FEI Number 1713910
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
ActionConsignees 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 Commerce25 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWF
510(K)s with Product Code = DWF
-
-