Edwards Lifesciences Swan-Ganz Thermodilution VIP recall
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Why was Edwards Lifesciences Swan-Ganz Thermodilution VIP recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413
- Product
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 32,145 units for all products in Recall Event
- Distribution
- 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).
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)