Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic mo
FDA device recall Z-2189-2012 · posted 2012-08-12 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 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), Lati
- Date initiated
- 2012-05-11
- Date posted
- 2012-08-12
- Date terminated
- 2014-06-17
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWAN-GANZ FLOW-DIRECTED THERMODILUTION (K810352) | American Edwards Laboratories | 1981-03-27 |