Recall Z-2195-2012
Edwards Lifesciences, LLC · initiated May 11, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
Codes / lots: 59174297, 59194298, 59194299, 59197887, 59203360, 59203361, 59207070, 59219837, 59247401, 59247402
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.
Details
- Recall number
- Z-2195-2012
- Initiated
- May 11, 2012
- Posted by FDA
- August 12, 2012
- Terminated
- June 17, 2014
- Product code
- DYG – Catheter, Flow Directed
- 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).
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2188-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2189-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2190-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2191-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2192-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2193-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2194-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2196-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2197-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |
| Z-2198-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | 05/11/2012Terminated |