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 Numbers in the above sequence with S.M.A.R.T CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.
FDA Recall Z-1039-2012 · Posted 2012-02-15
Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2012-01-31
Date Terminated2014-08-08
Product Quantity18,000 units
Reason for Recall
Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.