Events

Recall of S.M.A.R.T. TRANSHEPATIC BILIARY STENT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    80340
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The reason for the recall is due to the possibility of holes or tears in the tyvek side of the packaging in specific lots of this product. in the event a hole or tear in the tyvek side of the pouch is present loss of the sterile barrier could occur leading to use of a non-sterile device in the procedure.

Device

S.M.A.R.T. TRANSHEPATIC BILIARY STENT SYSTEM
  • Model / Serial
    Model Catalog: C08120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C07120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C06150MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C06120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C07150MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C08150MB (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    S.M.A.R.T. TRANSHEPATIC BILIARY STENT
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.