—#107296

Product

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 product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K031777
Affected lot / code info: Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB.

Why it was recalled

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 (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.

Timeline

Recall initiated: 2012-01-31
Posted by FDA: 2012-02-15
Terminated: 2014-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107296. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.