Recall Z-1586-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Guidant Endovascular Solutions, Inc.
Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
| Date | Sep 24, 2005 (initiated Aug 8, 2005) |
| Status | Terminated |
| Reason | This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter. |
| Root cause | Other |
| Action | (1 )Identify all customers world wide who have been shipped affected product from 01/01/2003 through 08/03/2005. (2)Contact and coordinate with LA District FDA Recall Coordinator, KEMA Notified Body, and other Competent Authorities outside the US as mandated by country local law. (3)Deliver Physiciam Medical Device recall Notice and Reconciliation Form via Federal Express in US/Mexico/ Puerto Rico. (4)Reconcile receipt notification and physical product returns to expected returns. |
| Quantity | 69,700 |
| Distribution | Nationwide and Argentina, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Dominican Republic, Findland, France, Germany, Greece, Hungary, Israel, Italy, Jordan, Lebanon, Malta, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, Spain, Tunisia |
| FDA record | Open on fda.gov |