Recall Z-1249-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Edwards Lifesciences, Llc
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
| Date | Jul 2, 2008 (initiated Dec 5, 2007) |
| Status | Terminated |
| Reason | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. |
| Root cause | Packaging process control |
| Action | Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779. |
| Quantity | Lot # FR6G0124 - 5 UNITS, FR6G0125 - 2 UNITS, FR6H0181 - 2 UNITS |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM Edwards Lifesciences, LLC, Dec 21, 2005 |