Recall Z-1039-2012 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog N
| Date | Feb 15, 2012 (initiated Jan 31, 2012) |
| Status | Terminated |
| Reason | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches. |
| Root cause | Packaging |
| Action | All affected consignees were notified by an "Urgent Medical Device Recall (Removal) Letter" dated January 31, 2012 and mailed by overnight delivery on February 1st and 2nd, 2012. Consignees were instructed to identify and quarantine affected product; review, complete, sign, and return an Acknowledgement Form; return the affected product per instructions. Questions should be directed to Customer Service at (800) 551-7683. |
| Quantity | 18,000 units |
| Distribution | Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp., Jul 7, 2003 |