Events

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

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    65003
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-17
  • 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
    Based on one complaint and the subsequent investigation cordis has determined that selected lots of s.M.A.R.T. flex biliary stent system have a potential for cracked luer hubs due to a manufacturing error. the luer hub is used to inject contrast/saline during procedure preparation prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline or in the worst case inability to flush the outer sheath of the catheter.

Device

S.M.A.R.T. FLEX BILIARY STENT SYSTEM
  • Model / Serial
    Model Catalog: SF06100MB (Lot serial: 41322); Model Catalog: SF06120MB (Lot serial: 41322); Model Catalog: SF09060MB (Lot serial: 41322); Model Catalog: SF10060SB (Lot serial: 41322); Model Catalog: SF10040SB (Lot serial: 40997); Model Catalog: SF06120MB (Lot serial: 40997); Model Catalog: SF06100MB (Lot serial: 40997); Model Catalog: SF09100SB (Lot serial: 40997); Model Catalog: SF09060MB (Lot serial: 40997); Model Catalog: SF10060SB (Lot serial: 40997); Model Catalog: SF10040SB (Lot serial: 41353); Model Catalog: SF06120MB (Lot serial: 41353); Model Catalog: SF06100MB (Lot serial: 41353); Model Catalog: SF09100SB (Lot serial: 41353); Model Catalog: SF09060MB (Lot serial: 41353); Model Catalog: SF10060SB (Lot serial: 41353); Model Catalog: SF10040SB (Lot serial: 41318); Model Catalog: SF06120MB (Lot serial: 41318); Model Catalog: SF06100MB (Lot serial: 41318); Model Catalog: SF09100SB (Lot serial: 41318); Model Catalog: SF09060MB (Lot serial: 41318); Model Catalog: SF10060SB (Lot serial: 41318); Model Catal
  • Product Description
    S.M.A.R.T. FLEX BILIARY STENT SYSTEM
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC