FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use

FDA device recall Z-1509-2013 · posted 2013-06-06 · Terminated

Recall details

Recalling firm

Cordis Corporation

Reason for recall

Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

FGE

Quantity affected

1357 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, Nether

Date initiated

2013-04-23

Date posted

2013-06-06

Date terminated

2014-06-27

Location

Miami Lakes, FL

Related 510(k) clearances