Events

Recall of Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61098
  • Event Risk Class
    Class 2
  • Event Number
    Z-1039-2012
  • Event Initiated Date
    2012-01-31
  • Event Date Posted
    2012-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107296
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, biliary, diagnostic - Product Code FGE
  • 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.
  • 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.

Device

Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent
  • Model / Serial
    Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
  • Product Description
    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.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA