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.
Recall
- Recall Number
- Z-1509-2013
- Event Number
- 65182
- Firm
- Cordis Corporation
- FEI Number
- 1016427
- Product Code
- FGE
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- April 23, 2013
- Posted
- June 6, 2013
- Terminated
- June 27, 2014
- Address
- 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802
Description
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.
Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
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), review, complete, sign and return the enclosed Acknowledgement Form and maintain a copy of this notice with the affected product. For questions related to the issue, please contact our FSS/Cordis representative, or please contact Cordis Direct at (800) 781-0282, Monday through Friday from 9:00 AM to 5:00 PM EDT.
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
1357 units