Events

Recall of SMARTSITE COMPONENTS AND EXTENSION SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA.

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
    35636
  • Event Risk Class
    II
  • Event Initiated Date
    2014-01-29
  • 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 affected smartsite connector lots may unintentionally disconnect from a female luer during infusion. an inability to disconnect may require replacement of a line.

Device

SMARTSITE COMPONENTS AND EXTENSION SETS
  • Model / Serial
    Model Catalog: 2000E (Lot serial: Contact manufacturer.); Model Catalog: 2000E (Lot serial: >10 serial numbers.)
  • Product Description
    SmartSite Needlefree Connector
  • Manufacturer
    CARDINAL HEALTH CANADA

Manufacturer

CARDINAL HEALTH CANADA
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC