Recall Z-0179-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Edwards Lifesciences, Llc
Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614
| Date | Nov 28, 2007 (initiated Mar 19, 2007) |
| Status | Terminated |
| Reason | Failure to deploy. |
| Root cause | Process control |
| Action | This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their invento |
| Quantity | 12 units |
| Distribution | Nationwide including states of OK, GA, CA WI, MO, and LA |
| 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 |