Recall Z-1507-2013 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
| Date | Jun 6, 2013 (initiated Apr 23, 2013) |
| Status | Terminated |
| Reason | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. |
| Root cause | Package design/selection |
| Action | Cordis sent an Urgent Medical Device Correction and Potential Removal letter dated April 24, 2013 e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected products to prevent further use of the affected product, until inspected. Use only product identified with a blue dot next to the lot number on the carton face label, carton end label, and outer pouch label, or product with upgraded sterile barrier system (not yet available, as of the date of this letter), rev |
| Quantity | 23 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081996 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc., Sep 15, 2009 |