FDAFDA · Food and drugs·Recall number Z-2196-2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
Published August 22, 2012 · Recall initiated: May 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
- Lot
- 59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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